EAST AFRICAN COMMUNITY

DRAFT 7: JANUARY, 2015

EAST AFRICAN COMMUNITY REGIONAL PROJECT PROPOSAL ON STRENGTHENING AND HARMONIZATION OF THE REGULATION OF

MEDICAL DEVICES AND DIAGNOSTICS IN THE EAST AFRICAN COMMUNITY PARTNER STATES

EAC Secretariat,

EAC Close

P.O. BOX 1096, Arusha, Tanzania

Tel: +255-27-2162100/14

Fax: Fax: +255-27-2162190

E-Mail: eac@eachq.org; health@eachq.org

Website: www.eac.int

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Table of Contents1.0 EXECUTIVE SUMMARY........................................................................................................... 3

2.0 DEFINITIONS............................................................................................................................. 4

3.0 BACKGROUND AND RATIONALE......................................................................................... 63.1 Republic of Burundi...........................................................................................................................73.2 Republic of Kenya............................................................................................................................... 73.3 United Republic of Tanzania (Mainland)...................................................................................83.4 United Republic of Tanzania (Zanzibar)....................................................................................83.5 Republic of Rwanda........................................................................................................................... 83.6 Republic of Uganda............................................................................................................................ 8

4.0 REGIONAL AND INTERNATIONAL REGULATORY HARMONIZATION LANDSCAPE........................................................................................................................................................... 12

4.1 EAC Medicines Regulatory Harmonization.............................................................................124.2 Regulation of medical devices and IVDs..................................................................................124.3 The Global Harmonization Task Force.....................................................................................134.4 Asian Harmonization Working Party (AHWP).......................................................................134.6 International Organisation for Standardisation...................................................................14

5.0 GOAL, PURPOSE AND OBJECTIVES................................................................................... 155.1 GOAL..................................................................................................................................................... 155.2 PURPOSE............................................................................................................................................. 155.3 OBJECTIVES........................................................................................................................................ 16

5.3.1 Specific objectives.......................................................................................................................................165.3.2 Attributable benefits..................................................................................................................................16

5.4 Project Framework Narrative..................................................................................................... 175.4.1 Objective 1:.....................................................................................................................................................175.4.2 Objective 2:.....................................................................................................................................................185.4.3 Objective 3:.....................................................................................................................................................195.4.4 Objective 4:.....................................................................................................................................................215.4.5 Objective 5:.....................................................................................................................................................21

6.0 PROJECT DESIGN AND IMPLEMENTATION...................................................................226.1 Management and Staffing Plan for this Project.....................................................................25

7.0 MONITORING AND EVALUATION..................................................................................... 27

8.0 SUSTAINABILITY................................................................................................................... 28

9.0 CITATIONS............................................................................................................................... 29

10.0 PROJECT FRAMEWORK AND BUDGET.........................................................................30

APPENDIX I Elements of regulation of medical devices and diagnostics..................39

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EAST AFRICAN COMMUNITY REGIONAL PROJECT PROPOSAL ON THE

STRENGTHENING AND HARMONIZATION OF THE REGULATION OF MEDICAL

DEVICES AND DIAGNOSTICS

1.0 EXECUTIVE SUMMARY

East African Community (EAC) is a regional inter-governmental organization of the five Partner

States, namely the Republic of Burundi, the Republic of Kenya, the Republic of Rwanda, the United

Republic of Tanzania and the Republic of Uganda, with its headquarters located in Arusha, Tanzania.

Access to medical devices and diagnostics for health in the EAC is limited by their availability and

cost, and there is uncertainty as to the safety and effectiveness of some products. Regulatory control

of medical devices and diagnostics is weak across the EAC with efforts to control the quality of

imported products largely confined to national disease programs for pathogens such as Human

Immunodeficiency Virus (HIV) and malaria. Weak regulation allows poor quality products to be

marketed. Inefficient regulation delays access to beneficial new products and increases costs to

manufacturers, inflating prices for consumers. Streamlining and harmonizing regulatory processes in

EAC Partners States can reduce delay and unnecessary expense, and improve access to new

products.

The primary aim of the East African Community Regional Project Proposal on Strengthening and

Harmonization of the Regulation of Medical Devices and Diagnostics is to enhance the health of the

population by improving access to diagnosis and treatment of communicable and non-

communicable diseases by ensuring access to safe and effective medical devices and diagnostics

though the enhancement of regulatory capacity and supporting the use of collaborative mechanisms

for regulatory approval in the region in accordance with the mandate provided by Article 118 of the

Treaty on the establishment of the EAC.

The project will be implemented by EAC Secretariat’s Health Department together with the National

Medicines Regulatory Authorities (NMRAs). In undertaking this project a Project Coordination team

operating within the EAC Secretariat will be responsible for the overall management and

implementation at regional level while national level activities will be undertaken by the technical

staff of the NMRAs’.

It is envisaged that the project will run for five years with the following objectives:

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i. To develop and implement regional harmonized regulatory and mutual recognition

framework for regulation of medical devices and in vitro diagnostics

ii. To develop and implement Quality Management System in EAC Partner States NMRA’s for

regulation of medical devices and in vitro diagnostics

iii. To build and improve human resource and infrastructural capacity for the regulation of

medical devices and diagnostics in the EAC region

iv. To develop and implement a regional integrated Information Management System (IMS) for

regulation of medical devices and in vitro diagnostics linked to all EAC Partner States and

EAC Secretariat

v. To establish and strengthen platforms for sharing developments in research and innovations

on medical devices and in-vitro diagnostics

The EAC harmonized regional medical devices and diagnostics regulation system will be sustained

through the existing organisational and institutional framework of the EAC Secretariat and Partner

States’ NMRAs. Financial resources to be mobilized will be used to support the project for the five

years of its duration. Subsequently, the cost of maintaining on-going project activities and personnel

will be borne by the EAC Secretariat and the Partner States’ NMRAs. The project staff at EAC

Secretariat and at the NMRAs will be absorbed and retained as regular staff in order to

institutionalize the harmonized regulatory systems.

This proposal was developed in consultation with the World Health Organization (WHO), London

School of Hygiene and Tropical Medicine (LSHTM), African Society for Laboratory Medicine (ASLM),

Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) and African Union New Partnership

for Africa’s Development (AU-NEPAD).

2.0 DEFINITIONS

The following definitions have been adopted from the IMDRF.

‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant,

reagent for in vitro use, software, material or other similar or related article, intended by the

manufacturer to be used, alone or in combination, for human beings, for one or more of the specific

medical purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

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investigation, replacement, modification, or support of the anatomy or of a physiologi-

cal process,

supporting or sustaining life,

control of conception,

disinfection of medical devices,

providing information by means of in vitro examination of specimens derived from

the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic

means, in or on the human body, but which may be assisted in its intended function by such means.

Note: Products which may be considered to be medical devices in some jurisdictions but not in

others include:

disinfection substances,

aids for persons with disabilities,

devices incorporating animal and/or human tissues,

devices for in-vitro fertilization or assisted reproduction technologies.

Medical devices vary greatly in complexity and application. Examples range from simple devices such

as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as

computers which assist in the conduct of medical testing, implants including those used for

contraception and prostheses. The design of medical devices constitutes a major segment of the

field of biomedical engineering.

Medical devices are assigned to one of four regulatory classes on the basis of its risk and the

evaluation necessary to demonstrate safety and effectiveness. Most class I devices (e.g.,

stethoscopes) are low-risk and subject only to “general controls,” such as tests of sterility. Class II

devices (e.g., computed tomographic scanners) meet general controls as well as “special controls,”

such as additional labeling requirements. Class III products (e.g., deepbrain stimulators and

implantable cardioverter–defibrillators) require clinical studies evaluating the safety and

effectiveness of the device. Class IV are of high risk and require design/clinical trial reviews, product

certification, and an assessed quality system involving clinical trials.

‘In-Vitro Diagnostic (IVD) medical device’ means a medical device, whether used alone or in

combination, intended by the manufacturer for the in-vitro examination of specimens derived from

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the human body solely or principally to provide information for diagnostic, monitoring or

compatibility purposes.

Note 1: In-vitro Diagnostic (IVD) medical devices include reagents, calibrators, control materials,

specimen receptacles, software, and related instruments or apparatus or other articles and are used,

for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring,

predisposition, prognosis, prediction, determination of physiological status.

Note 2: In some jurisdictions, certain In-vitro Diagnostic (IVD) medical devices may be covered by

other regulations.

Note 3: Because In-vitro Diagnostics (IVDs) are a subset of medical devices, the internationally

acknowledged regulatory framework for IVDs is very similar to that of medical devices. Jurisdictions

therefore chose to establish one regulation for medical devices that encompasses IVDs (for example

United States Food and Drug Administration, Therapeutic Goods Administration of Australia), with

specific requirements for IVDs identified within, or as a separate but aligned regulation (for example,

the European directives for medical devices and IVDs).

In vivo diagnostics are used to make test within the body, such as imaging equipment (UltraSonography and Manometry) as opposed to vitro diagnostics test a sample of tissue or bodily fluids.

3.0 BACKGROUND AND RATIONALE

East African Community is a regional inter-governmental organization of the five Partner States,

namely the Republic of Burundi, the Republic of Kenya, the Republic of Rwanda, the United Republic

of Tanzania and the Republic of Uganda, with its headquarters located in Arusha, Tanzania

(www.eac.int). The region covers an area of approximately 2.0 million square kilometres, has a

combined gross domestic product of US$110 billion and an estimated population of over 143.5

million people who share a common history, language, culture and infrastructure a. These advantages

provide the Partner States with a unique framework for regional co-operation and integration in

various political, economic, social and cultural areas of common interest. These include joint action

in prevention, control and management of communicable and non-communicable diseases of public

health concern; harmonization of health policies and regulation; and promotion of information

exchange on health issues which are explicitly detailed in Chapter 21 (Article 118) of the EAC Treatyb.

a EAC Facts and Figures Report 2014b EAC Treaty available at www.eac.int

EAC6

[The map should be placed to the left of the text above it]

The five EAC Partner States have six (6) National Medicines Regulatory Authorities (NMRAs) namely

Department of Pharmacy and Medical Laboratories (DPML) of Burundi, Pharmacy Task Force (PTF) of

Rwanda, Pharmacy and Poisons Board (PPB) of Kenya, Tanzania Food and Drugs Authority (TFDA),

Zanzibar Food and Drugs Board (ZFDB) and National Drug Authority (NDA) of Uganda. The current

status of the regulation of medical devices and in-vitro diagnostics in the EAC is as follows:

3.1 Republic of Burundi

In the Republic of Burundi, the regulation of medicines, medical devices and diagnostics falls under

the Department of Pharmacy, Medicines and Laboratories (DPML) in the Ministry of Public Health

and Fight Against AIDS. However, there are advanced institutional arrangements towards the

establishment of the proposed Burundi Medicines Regulatory Authority (ABREMA), once the draft

law is approved and enacted by the Senate of Burundi.

3.2 Republic of Kenya

The Pharmacy and Poisons Board (PPB) was established in 1957 under the Pharmacy and Poisons Act

(Chapter 244), with the legal mandate to control the trade in medicines and poisons and to regulate

the practice of pharmacy. PPB’s Registration of Drugs Rules, Legal Notices on 147/1981, 142/1991

and 192/2010 allowed it to start regulating medical devices in Kenya. The Pharmaceutical Sector

Regulation 4.1.3 is paving way for the establishment of a national Food and Drug Authority (FDA),

responsible for protecting the public health by assuring the safety, efficacy, quality and security of

human and veterinary drugs, biological products, medical devices, cosmetics, tobacco products,

complementary/alternative and herbal medicines and products that emit radiation.

The Pharmaceutical Sector Regulation 4.1.4 will transform the National Quality Control Laboratory

into a state corporation with expansion of its mandate and capacity to include testing of medical

devices, food products, cosmetics. There is currently a requirement to register and pay importation

fees for all medical devices and diagnostics to the Kenya Medical Technicians and Technologists’

Board.

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3.3 United Republic of Tanzania (Mainland)

Tanzania Food and Drugs Authority (TFDA) is responsible for ensuring that all medicines, cosmetics

and medical devices are correctly evaluated for quality, safety and effectiveness before being

approved for use. TFDA is also responsible for inspection and enforcement of medicines, cosmetics

and medical devices. Control of clinical trials and adverse drug reactions monitoring and evaluation

are also regulated by TFDA. Private Health Laboratories Board is currently mandated to regulate in

vitro diagnostic devices. However, processes are underway to confer the mandate to TFDA.

3.4 United Republic of Tanzania (Zanzibar)

The Zanzibar Food and Drugs Board is a semi-autonomous agency responsible for the regulation of

medicines, medical devices, diagnostics and food established by the Zanzibar Food, Drugs and

Cosmetics Act of 2006

3.5 Republic of Rwanda

All matters pertaining to the control of pharmaceuticals including drugs, devices and diagnostics are

handled by the Pharmacy Task Force (PTF) under the Ministry of Health of Rwanda. An act of

parliament (No. 74/2013 of 11/09/2013) has been passed to establish the Rwanda Food and

Medicines Regulatory Authority (RFMRA).

3.6 Republic of Uganda

The National Drug Authority (NDA) was established by the National Drug Policy and Authority Act

Cap 206 of the Laws of Uganda. It is mandated to regulate the quality, safety and efficacy of drugs.

NDA is also involved to some extent in the regulation of medical devices and diagnostics though not

explicitly mandated by the law. Specifically NDA performs physical inspection of imported medical

devices at the ports of entry. For the locally manufactured medical diagnostics NDA performs quality

audits annually. The National Drug Quality Control Laboratory (NDQCL) tests all batches of medical

gloves, male latex condoms and insecticide treated mosquito nets before they are released for use

by the population.

A baseline survey on regulatory activities for medical diagnostics in EAC and other selected African

countries undertaken in 2012 found that the capacity to regulate medical devices and diagnostics

was limited in terms of skills and human resource. The survey noted that in some countries the

regulation of medical devices and diagnostics had been delegated to the NMRAs while in other

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countries Ministry of Health departments were involved. Control of medical devices and diagnostics

was largely confined to those used by national disease programs such as Human Immunodeficiency

Virus (HIV) and malaria. In addition, some activities to evaluate medical devices and diagnostics were

performed in research laboratories but post market surveillance was rarely done.

Table 1: Summary of regulatory activities for medical diagnostics in East Africa and other selected

African countries.

Generally, the regulatory landscape for medical devices and diagnostics in EAC was found to be weak

and inefficient. While much effort and resources have been placed in strengthening regulation of

medicines, the area of medical devices including in vitro diagnostics has been forgotten or very little

effort has been made towards their regulation. Weak regulation allows defective or substandard

products to be marketed. Inefficiency in regulation causes unnecessary delay and increases costs to

manufacturers and consumers. Wrong diagnosis resulting from a defective or substandard device

may result in a complete failure of the whole treatment cycle including wrong medication and may

result into death. Therefore, the issue of safety and performance of medical devices and diagnostics

cannot be underestimated.

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In almost all five countries in East Africa with the exception of Tanzania, nothing much has been done

in terms of regulation of medical devices and in vitro diagnostics. EAC is bordered by seven countries

which do not have any system yet to regulate devices. Therefore, the region is prone to influx of

substandard or counterfeit medical devices from the bordering countries through the multiple porous

borders. The other concern is the fact that in all the five EAC countries there are few or no

manufacturing facilities for devices and therefore at least 80-90% of these products are imported. A

report by Mori M, Ravinetto R & Jacobs J et al (2011); Quality of Medical Devices and In Vitro

Diagnostics in Resource Limited Settingsc showed that there were limited reports and evidence with

regards to poor quality medical devices and this was mainly due to:

(i) the poor regulatory oversight of medical devices and in vitro diagnostics in resource-limited

settings;

(ii) a general lack of awareness of the problem of poor-quality medical devices and in vitro

diagnostics amongst the scientific community and decision-makers; and

(iii) poor quality assurance in diagnostic laboratories in resource-poor settings, precluding

tracing quality problems of IVDs from the other potential causes of diagnostic inaccuracy.

The report went further to cite examples of reported substandard and defective products found in

different parts of the world including Africa. This proves that poor quality products can easily find

ways into the market especially those that are poorly regulated. Some of the examples are Syphilis

Rapid Plasma regain (RPR) purchased in Tete, Mozambique in January 2007; malaria rapid tests in

Benin in May 2007; malaria rapid tests in the Republic of South Africa in June 2010 and HIV

diagnostic test in Kinshasa, March 2011.

In order to address the challenges, the East African Community has developed a Regional Project on

Strengthening and Harmonization of the Regulation of Medical Devices Including In Vitro Diagnostics

to enhance the regulatory capacity of NMRAs and supporting the use of collaborative mechanisms

for regulatory approval in the region. The project will focus on the coordination, capacity

strengthening and harmonization of regional policies, regulations, standards, guidelines and

procedures for the regulation and post-market surveillance of medical devices and diagnostics

through the organizational and institutional strengthening of the existing EAC Partner States’

National Medicines Regulatory Authorities (NRAs) and the establishment of the proposed East

African Community Medicines and Food Safety Commission (EACMFSC).

c Quality of Medical Devices and In Vitro Diagnostics in Resource Limited Settings

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4.0 REGIONAL AND INTERNATIONAL REGULATORY HARMONIZATION

LANDSCAPE

4.1 EAC Medicines Regulatory Harmonization

As part of collaboration on matters of health generally and in particular harmonization of regulation

of health products, the Partner States through their NMRAs are currently implementing the EAC

Medicines Regulatory Harmonization Project (EAC-MRH). The goal of EAC-MRH is to have

harmonized and functioning medicines regulatory systems within the EAC in accordance with

national and internationally recognized standards. So far, the EAC-MRH has been able to develop

harmonized standards for medicines evaluation and registration, Good Manufacturing Practices,

Quality Management Systems and is in the process of establishing common information

management systems in all NMRAs. Collaborative mechanisms for drug regulatory systems and

processes at the regional level should translate into improved regulatory approval processes and

operational efficiencies at the national level. In this regard, the project will increase the capacity of

the national medicines regulatory authorities and specifically strengthen the administrative,

structural and technical elements of medicine regulation. In doing so, the project will help countries

to enhance and facilitate their decision-making processes regarding the registration of medicines, as

well as exercise more control over medicines circulating on the market. The long term vision of EAC-

MRH is to expand the scope of regulation to cover other product streams such as medical devices

including in-vitro diagnostics, biological products and other regulatory functions including clinical

trials and post marketing surveillance (PMS).

4.2 Regulation of medical devices and IVDs

The World Health Organization (WHO) Prequalification of Diagnostics Programme which aims to

promote and facilitate access to safe, appropriate and affordable diagnostics of good quality in an

equitable manner has evaluated and prequalified a selection of diagnostic products for malaria and

HIV. They have published guiding principles on the regulation of medical devices based on

International Medical Devices Regulators Forum (IMDRF) regulatory model. Documents have also

been developed to assist with evaluation of diagnostics for persons living with HIV and for reporting

post market complaints of WHO prequalified products. The Programme has previously assisted the

Tanzania Food and Drugs Authority to prepare for their forthcoming role as regulators of IVDs,

including developing a strategy for post market surveillance. Currently, Tanzania is the only EAC

Partner State that has adopted a regulatory system based on IMDRF/GHTF recommendations.

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4.3 The Global Harmonization Task Force

The Global Harmonization Task Force (GHFT) was conceived in 1992 in response to the growing need

for international harmonization in the regulation of medical devices to ensure the safety,

effectiveness and quality of medical devices. Harmonization can promote technological innovation

and facilitate international trade. GHTF was a voluntary group of representatives from national

medical device regulatory authorities and the medical device industry. Its Founding Members are

Australia, Canada, Japan, USA and the European Union. Chairmanship of the GHTF rotated among

the representatives of the five Founding Members. The GHTF published and disseminated

harmonized documents on basic regulatory practices and served as an information exchange forumd.

In 2012, GHTF transitioned to a purely regulatory body called the International Medical Devices

Regulatory Forum (IMDRF) which will continue to promote the principles of harmonization.

4.4 Asian Harmonization Working Party (AHWP)

Convergence in Asia is being facilitated by the work of the Asian Harmonization Working Party

(AHWP)e, a voluntary organisation of regulators and manufacturers from 23 member economies

(Abu Dhabi, Brunei Darussalam, Cambodia, Chile, Chinese Taipei, Hong Kong SAR, China, India,

Indonesia, Jordan, Kingdom of Saudi Arabia, Korea, Laos PDR, Malaysia, Myanmar, Pakistan,

People's Republic of China, Philippines, People's Republic of China, Singapore, South Africa, Thailand,

Vietnam and Yemen). AHWP aims to promote harmonization among its member economies through

the adoption and application of GHTF guidance documents in collaboration with APEC and the

Association of East Asian Nations (ASEAN) and other related international organizations. AHPW

provides a platform for the harmonization of medical device regulations among member economies

to ensure safety, quality, and effectiveness of medical devices marketed in its member economies.

Seven AHWP working groups have been established to develop practical guidance on

implementation of GHTF recommendations.

4.5 Pan-African Harmonization Working Party

d www.imdrf.orge http://www.ahwp.info/

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The Pan-African Harmonization Working Party on Medical Devices and Diagnostics (PAHWP) fwas

conceived in 2012. It is a voluntary body whose mission is to improve access to safe and affordable

medical devices and diagnostics in Africa though harmonized regulation and forums such as the

African Regulatory Forum on Medical Diagnostics. PAHWP aims to study and recommend ways to

ensure tests are safe and effective while minimizing costs and delays, allowing faster access to

cheaper products. The work of PAHWP was facilitated by the London School of Hygiene and Tropical

Medicine (LSHTM) with grant funding from Grand Challenges Canada (GCC). The PAHWP is housed

under the African Union-New Partnership for Africa's Development (AU-NEPAD) Planning and

Coordinating Agency. Founding members include the East African Community Health Secretariat

(EAC) and the EAC Partner States, Ethiopia, Nigeria and South Africa and LSHTM. Partners include

German International Co-operation (EAC-GIZ), the African Society for Laboratory Medicine (ASLM)

and the WHO. The priority areas for PAHWP are:

i. Common risk classification system

ii. Common registration file

iii. Reduction in duplication of clinical performance studies by joint review of data

iv. Reduction in duplication of manufacturing audits through adoption of the single audit

programme similar to the MD-SAP initiative

v. Post-marketing surveillance

4.6 International Organisation for Standardisation

The International Organisation for Standardisation (ISO) is a federation of national standards bodies

that works with the International Electro technical Commission (IEC) on standards and terminology

in the areas of electrical, electronic and related technologies. Kenya, Rwanda, Tanzania and Uganda

have Membership to ISO through their national standards bodies and Burundi has correspondent

Membership status. The adoption of different standards by individual countries creates technical

barriers which may hinder the flow of goods between countries. To overcome this EAC NMRA will

apply common standards for regulation of medical devices and in vitro diagnostics.

4.7 African Organization for Standardisation

The African Organization for Standardisation (ARSO)g is an intergovernmental body that works under

the auspices of the African Union, with the principal mandate to harmonise African Standards and

conformity assessment procedures in order to reduce technical barriers and promote trade. ARSO

f http://www.pahwp.org/ghttp://www.arso-oran.org/

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have not published standards specific for medical devices or IVDs but have adopted some general

ISO standards for quality systems.

The proposed EAC project will utilize the experience of the above harmonization initiatives and

expertise, in particular those of IMDRF and WHO.

5.0 GOAL, PURPOSE AND OBJECTIVES

5.1 GOAL

The goal is to enhance the health of the population by improving access to quality medical devices and in vitro diagnostics for management of diseases and other health conditions.

5.2 PURPOSE

The purpose is to enhance the health of the population in Partner States by improving access to

diagnosis and treatment of communicable and non-communicable diseases by ensuring access to

safe and effective medical devices and diagnostics though the enhancement of regulatory capacity

and supporting the use of collaborative mechanisms for regulatory approval in the region in

accordance with the mandate provided by Article 118 of the Treaty on the establishment of the EAC.

The implementation of this project will focus on the coordination, capacity strengthening and

harmonization of regional policies, regulations, standards, guidelines and procedures for the

regulation and post-market surveillance of medical devices and diagnostics through the

organizational and institutional strengthening of the existing EAC Partner States’ National Medicines

Regulatory Authorities (NRAs) and the establishment of the proposed East African Community

Medicines and Food Safety Commission (EACMFSC).

Setting international standards and streamlining the regulatory process for medical devices and

diagnostics will diminish the regulatory burden, lower costs, reduce delays and provide a basis for

mutual recognition of regulatory decisions among Partner States’ NMRAs. Ultimately, a product

registered under the harmonized rules in one EAC Partner States shall be accepted for registration in

all EAC Partner States without further review, other than to check that the documentation submitted

to the regulatory body is complete.

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5.3 OBJECTIVES

The overall objective of the project is to establish a harmonised framework for regulation of medical

devices and in vitro diagnostics in EAC Partner States based on internationally accepted principles

and standards.

5.3.1 Specific objectives

i. To develop and implement regional harmonized regulatory and mutual recognition

framework for regulation of medical devices and in vitro diagnostics

ii. To develop and implement Quality Management System in EAC Partner States NMRA’s for

regulation of medical devices and in vitro diagnostics

iii. To build and improve human resource and infrastructural capacity for the regulation of

medical devices and in vitro diagnostics in the EAC region

iv. To develop and implement a regional integrated Information Management System (IMS) for

regulation of medical devices and in vitro diagnostics linked to all EAC Partner States and

EAC Secretariat

v. To establish and strengthen platforms for sharing developments in research and innovations

on medical devices and in-vitro diagnostics

5.3.2 Attributable benefits

The project will address the problems associated with weak and inefficient regulation of medical

devices and diagnostics and contribute the following benefits:

i. Communities/patients: The population of EAC will enjoy better health outcomes due to

improved access to safe and effective medical devices and in vitro diagnostics for diagnosis

and management of diseases. Collaborative approaches will facilitate introduction of new

products into the market and lower cost recovery by manufacturers will make products

more affordable.

ii. National Medicines Regulatory Authorities: Streamlined approval processes will reduce

duplication of efforts by the NMRAs and they will be better equipped to assess devices and

diagnostics in a timely and efficient manner through collaborative mechanisms.

iii. Development Partners: There will be more efficient use of resources from development

partners to address the challenges in regulation and procurement of medical devices and in

vitro diagnostics.

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iv. Industry: The streamlined processes will facilitate compilation and submission of technical

files to NMRAs medical devices and diagnostics regulatory authorities. Reduction in

duplication of clinical evaluation and manufacturing audits as well as faster approval times

will translate into cost savings and boost investment potential of the East African market.

5.4 Project Framework Narrative

5.4.1 Objective 1:

To develop and implement regional harmonized regulatory and mutual recognition framework for

regulation of medical devices and in vitro diagnostics.

Milestone: Harmonized Legal and Mutual Recognition for regulation of medical devices and in vitro

diagnostics in the EAC region developed and implemented by end of year five (5)

Activities:

i. Review existing national policies and legal frameworks using WHO National Regulatory

Authorities (NRAs) assessment guidelines and IMDRF/GHTF requirements as a benchmark.

ii. Development of EAC regional harmonized policy for regulation of medical devices and in

vitro diagnostics.

iii. Development of EAC regional legal framework for regulation of medical devices and in vitro

diagnostics.

iv. Development of regional mutual recognition framework (MRF) for regulation of medical

devices and in vitro diagnostics.

v. Conduct sensitization meetings with national and regional stakeholders including

parliamentarians.

vi. Develop and adopt EAC harmonized guidelines and SOP’s for pre market registration, market

and post-market control based on GHTF and IMDRF

vii. To adopt international harmonized guidelines for quality audits of medical devices and in

vitro diagnostics manufacturers.

Description (Activities):

The strategic objective focuses on development and implementation of regional harmonized

policies, legal and regulatory framework for regulation of medical devices and in vitro diagnostics in

EAC Partner States. In order to achieve this, the EWG on Pharmaceutical Policy, Legal and

Regulatory Reform as well as the EWG on Medical Devices and In Vitro Diagnostics will spearhead

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the review of the existing policies and laws. In addition the EWG on Medical Devices and In Vitro

Diagnostics will formulate harmonized guidelines and procedures for:

i. Premarket controls: definition of medical devices, common nomenclature, risk-based

classification, clinical evaluation, dossier submission template (CDST), quality audits and

standards.

ii. Market controls: import and export, advertising and labelling.

iii. Post market controls: adverse events monitoring, sample collection and testing and recalls.

The development of the harmonized regulatory framework will be done with the involvement of

stakeholders.

5.4.2 Objective 2:

To develop and implement Quality Management System in EAC Partner States NMRA’s for regulation

of medical devices and in vitro diagnostics.

Milestone:

Quality Management System for regulation of medical devices and in vitro diagnostics established at

the end of year five (5).

Activities:

i. Develop and implement QMS requirements for medical devices and in vitro diagnostics for

NMRAs and quality control laboratories in line with internationally recognized standards

ii. Dissemination and capacity building on the developed guidelines and SOPs in Partner States

iii. Piloting joint audit using the developed QA tools

iv. Conduct audits of the NMRAs and quality control laboratories to facilitate certification

Description:

Currently, all Partner States have no QMS for medical devices and in vitro diagnostics. Development

of QMS for regulating medical devices is of paramount importance in order to ensure consistency in

quality and safety of medical devices within the Region. The strengthening of quality management

systems in NMRAs and quality control laboratories will facilitate uniformity of procedures and

decision making processes as well as mutual recognition hence improving the quality of medical

devices and in vitro diagnostics available in the region.

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In implementing this objective manuals, guidelines and standard operating procedures will be

developed in consultation within the partner states and reference will be made to existing processes

in the region as well as those of WHO and well resourced NMRAs.

5.4.3 Objective 3:

To build and improve human resource and infrastructural capacity for the regulation of medical

devices and in vitro diagnostics in the EAC region

Milestones:

i. A pool of well trained and motivated regional experts to regulate medical devices and

diagnostics in the EAC market established by year five (5)

ii. A regional centre of excellence in training of regulation of health products by year five (5)

Activities:

i. Strengthen infrastructure capacity of NMRAs and Laboratories for regulation of medical

devices and diagnostics

ii. Recruit national and regional staff to implement the project

iii. Conduct regional trainings to NMRAs and laboratory technologists on assessment of quality

and safety of medical devices and in vitro diagnostics.

iv. Identify and utilize opportunities for e-learning

v. Facilitate regional and international staff exchange and/or twinning programmes on

regulation of medical devices and diagnostics

vi. Conduct joint assessment of dossiers for registration of medical devices and in vitro

diagnostics.

vii. Conduct joint quality audits of manufacturer’s of medical devices and in vitro diagnostics

viii. Conduct joint laboratory evaluation

ix. Establish regional centres of excellences to provide continuous training programme on

regulation of medical devices

Description:

Human resource capacity at both NMRAs and EAC Secretariat is of paramount importance to

successfully establish functional and harmonized medical devices and in vitro diagnostics regulatory

systems. It is for this reason that the following persons will be recruited:

18

EAC Secretariat

i. Senior Health Officer (Medical Devices and Diagnostics Regulation) – Pathologist (P2)

ii. Health Officer (Medical Devices) – Biomedical Engineer (P1)

iii. Health Officer (Diagnostics) – Laboratory Technologist (P1)

National Medicines Regulatory Authorities

i. Health Officer (Medical Devices) – Biomedical Engineer (P1)

ii. Health Officer (Diagnostics) – Laboratory Technologist (P1)

iii. e-Health Information Systems Expert (P1)

The above staff will work within the existing structure of the EAC Secretariat’s Health Department

and together with the following existing staff:

Senior Health Officer (Medicines Regulation) (EAC P2),

National Medicines Regulation Officers (EAC P1)

e-Health and Informatics Expert (EAC P1),

Accountant (EAC P1)

Pharmaceutical Programme Assistant (EAC G5) at the regional level

To facilitate the work of the recruited staff as well as implementation of other objectives office

equipment will be procured and installed in all Partner States and at the EAC Secretariat. There will

also be a series of trainings conducted on project management, pre market, market and post market

controls. To institutionalize these trainings in the existing regional and national programmes,

regional centres of excellence will be identified. Staff exchange will be organized between EAC

NMRAs and well-resourced NMRAs. Joint laboratory evaluation, assessment of dossiers for

registration, quality audits of manufacturer’s of medical devices and in vitro diagnostics will be

conducted regularly as part of capacity building.

5.4.4 Objective 4:

To develop and implement a regional integrated Information Management System (IMS) for

regulation of medical devices and in vitro diagnostics linked to all EAC Partner States and EAC

Secretariat.

Milestone: Regional integrated information management system established and linked to all

Partner States by end of year three (3).

19

Activities:

i. Mapping of regulatory processes for medical devices and in vitro diagnostics.

ii. Procure, install and maintain Information Management System (IMS) equipment for all EAC

Partner States and EAC Secretariat

iii. Training of staff on the use of IMS for regulation of medical devices and in vitro diagnostics.

iv. Package and disseminate regulatory information and best practices on medical devices and

in vitro diagnostics.

Description:

The integrated information management system will be installed and linked in all EAC partner states

by end of year three (3). In the first year, EAC will facilitate the regional mapping of medical devices

and in vitro diagnostics regulatory processes. The exercise will help to identify the gaps in different

NMRAs. In addition, in year one, experts from the Partner States will develop systems requirement

for the IMS solutions. All the regulatory processes will be covered.

In year two and three, installation, training and maintenance of the IMS will be done. The system

will continue to be used through years four and five.

5.4.5 Objective 5:

To establish and strengthen platforms for sharing developments in research and innovations on

medical devices and in-vitro diagnostics

Milestone:

Increase visibility for regulation of medical devices and in vitro diagnostics within broad range of

stakeholders throughout the five (5) years of the project’s duration.

Activities:

i. Enhancing NMRAs participation in national, regional and international fora to share

information and best practices on regulation of medical devices and in vitro diagnostics.

ii. Organise and participate in symposia on medical devices and in vitro diagnostics within the

margin of existing regional and continental health research scientific conferences.

Description:

20

Under this objective, the EAC Secretariat will support collaboration between NMRAs and partners so

as to ensure that the region keeps pace with advances in technology. Specifically, the NMRAs will

participate in regional and international meetings, such as meetings of the Pan African

Harmonization Working Party (PAHWP), African Society for Laboratory Medicine (ASLM),

International Medical Devices Regulators Forum (IMDRF), Asian Harmonization Working Party

(AHWP), Latin American Alliance for the Development of In Vitro Diagnostics (ALADDIV) and London

School of Hygiene and Tropical Medicine (LSHTM).

The NMRAs will endeavour to inform the public and interested parties, including manufacturers and

distributors of medical products, of the harmonised regulation of medical device and diagnostics in

EAC Partner States through website and advocacy materials, articles in the media, articles in

newsletters and presentation of papers at international symposia including the East African Health

and Scientific Conference.

6.0 PROJECT DESIGN AND IMPLEMENTATION

At regional level the EAC medical devices and diagnostics regulation harmonization will be

implemented within the existing EAC Secretariat organizational and institutional structures and

financial management systems and procedures, which among others include; EAC Organizational

and Staffing Structure (2007), EAC Staff Rules and Regulations (2006), EAC Financial Rules and

Regulations (2006), EAC Procurement Manual and Procedures, EAC Policy and Budget Approval

Process through the EAC Council of Ministers, and EAC Audit Commission composed of EAC Partner

States’ National Audit Commissions.

The Project Coordination Team based at the EAC Secretariat will operate under the overall

supervision of the EAC Principal Health Officer (as indicated in Fig 2) and will focus on the overall

project management and implementation. The Project Coordination Team will also play the Secretariat role

to the Project Steering Committee comprised of heads of Partner States’ NMRAs for medical devices and

diagnostics. National level coordination will be through focal points at the respective NMRAs supported by

this project.

All technical matters including drafting of technical guidelines and procedures shall be done by EWG

on medical device and in vitro diagnostics which shall be constituted by members drawn from all the

six (6) NMRAs. The EWG shall meet regularly at least twice a year to develop the Annual Work Plans

and Budgets and draft technical documents. The Annual Work Plans and Budgets (AWPBs) and draft

21

technical documents developed by the EWG will be presented to the Project Steering Committee for

review and adoption and thereafter onward submission to the EAC Sectoral Committee on Health for

consideration in accordance with existing EAC Governing Structures.

The areas of focus shall be;

iv. Premarket controls: definition of medical devices, common nomenclature, risk-based

classification, clinical evaluation, dossier submission template (CDST), quality audits and

standards.

v. Market controls: import and export, advertising and labelling.

vi. Post market controls: adverse events monitoring, sample collection and testing and recalls.

Members EWG will regularly carry out their tasks within the individual regulatory body according to

the assigned tasks and thereafter meet at least twice a year to jointly review and approve their

reports before presentation to the Project Steering Committee. Both the Project Team and National

MRH Focal Points will participate in EWG meetings to provide both technical and secretariat support.

The EWG may when required invite to their meetings experts from other institutions with relevant

knowledge and experience.

Under the proposed project technical assistance will be required to support the implementation of

the project. Particularly knowledge and skills transfer and guidance in development of the medical

devices and in vitro diagnostics regulatory system for the EAC. The following institution may be

requested for technical assistance: WHO, ASLM, LSHTM, NRAs or any other technical expert groups

22

Implementation Arrangements for EAC Medical Devices & Diagnostics Project

Organizational and institutional structures and financial management systems exist in each of the

Partner States though with varying capacities. In this respect, training to the staff of the regulatory

authorities has been incorporated in this project.

EAC has previously developed, implemented and managed various health projects including:

1. SIDA/Norway/IrishAID– “EAC Regional Integrated Multisectoral HIV and AIDS Programme:

2008 - 2013”– USD $ 6,842,128.00over five years (FY 2009 -2013)

2. Rockefeller Foundation (RF) – “East African Integrated Disease Surveillance Network

Regional Project to Strengthen Cross-Border Human and Animal Disease Prevention and

Control in the East African Community Partner States: 2004 - 2012” – 1 st Grant worth USD $

USD $ 406,760.00 over four years from 1st October 2004 to 30th September 2008 and 2nd

Grant worth USD $500,000.00 over three years(1st October 2008 to 30th September 2011).

• Advocacy•AgencyNEPAD

TA•

WHO, LSHTM,FDA, ASLM

harmonization• Policy & Guidelines

for •

consultationsParticipation in •Nomination of experts•

Expert Working Group

Ministers of HealthEAC Sectoral Council of

EAC Council of Ministers

HealthEAC Sectoral Committee on

Audit Annual •Finance ReportsInterim •

procurement planConsolidated Budget & •

Work PlansRegional Annual •

ReportsQuarterly performance •Plans Procurement •

Annual Budgets •Work PlansNMRA Annual •

Project Steering Committee

EAC Project Coordination Team (EAC SECRETARIAT)

5NMRA 4NMRA NMRA 3NMRA 2NMRA 1

23

3. Federal Government of Germany (BMZ) through the German Technical Cooperation

Agency (GTZ) – “Regional Project to Strengthen the East African Community Partner States in

the area of WTO/TRIPS and Pharmaceutical Production: 2009 - 2011”–€800,000.00 over

three years (FY 2009 – 2011).

4. European Commission (EC) – “The East African Community Regional Sexual and

Reproductive Health and Rights Programme (Invest in Adolescents: Building Advocacy

Capacity in East Africa ): 2010 - 2013” – (EURO 1.497.959.00)

5. European Commission (EC) – “EAC Regional Programme for the Prevention and Control of

Human and Animal Trans-boundary Diseases in East Africa: 2007 – 2012” – USD

3,000,000.00 over three years (FY 2008 – 2012)

6. EC/ACP/WHO Partnership on Pharmaceutical Policies – “Regional Harmonization of

Medicines Policy and Regulation in the East African Community Partner States Project:

March 2004 – September 2010” – USD $421,478.00 was earmarked for EAC Countries

through WHO-AFRO and the regional activities of the project were coordinated by the

Principal Health Officer (PHO) of the EAC Secretariat in collaboration with the EAC Partner

States’ National Medicines Regulatory Authorities (NRAs) and the WHO Country Offices in

each of the respective EAC Partner States.

Management and Staffing Plan for this Project

Human resource capacity at both NMRAs and EAC Secretariat is of paramount importance to

successfully establish functional and harmonized medical devices and in vitro diagnostics regulatory

systems. It is for this reason that the following new project staff will be recruited under the EAC

Secretariat Health Department in accordance with the existing EAC Staff Rules and Regulations.

EAC Secretariat

iv. Senior Health Officer (Medical Devices and In Vitro Diagnostics Regulation) – Pathologist (P2)

v. Health Officer (Medical Devices) – Biomedical Engineer (P1)

vi. Health Officer (In Vitro Diagnostics) – Laboratory Technologist (P1)

National Medicines Regulatory Authorities

vii. Health Officer (Medical Devices) – Biomedical Engineer (P1)

viii. Health Officer (In Vitro Diagnostics) – Laboratory Technologist (P1)

ix. e-Health Information Systems Expert (P1)

24

The above staff will work within the existing structure of the EAC Secretariat’s Health Department

together with the following existing staff:

Principal Health Officer – Health Department (P3)

Senior Health Officer (Medicines and Food Safety Unit) (P2)

Senior Health Officer (Medicines Regulation) (P2)

National Medicines Regulation Officers (P1)

e-Health and Informatics Expert (P1),

Accountant (P1)

Pharmaceutical Programme Assistant (G5) at the regional level

The Senior Health Officer (Medical Devices and In Vitro Diagnostics Regulation) will be responsible

for the technical coordination and implementation of the EAC Regional Medical Devices and

Diagnostics Regulation Harmonization Program on full time basis under the supervision of the Senior

Health Officer in charge of Medicines and Food Safety. In addition, the other staff will jointly and

individually support the implementation of the approved regulatory activities for medical devices

and diagnostics at both EAC regional level and at country level.

The project will run for five years and will focus on the coordination, capacity strengthening, quality

assurance and harmonization of regional policies, regulations, standards, guidelines and procedures

for the regulation of medical devices and diagnostics through the organizational and institutional

strengthening of the existing EAC Partner States’ National Medicines Regulatory Authorities (NRAs)

and the establishment of the proposed East African Community Medicines and Food Safety

Commission (EACMFSC).

In the first year, the EAC will facilitate a region wide assessment of the existing policies and laws on

regulation of medical devices and diagnostics. The assessment will compare the regulatory situation

in each country to the internationally accepted regulatory model of GHTF/IMDRF. The legal,

institutional and human resource gaps required for effective regulation will be identified. The

findings and recommendations of the assessment will guide the review and development of national

and regional policies and laws including the EAC mutual recognition framework. The laws will be

developed through consultative processes involving stakeholders from legislature, NMRAs, industry,

academia, professional associations, consumer associations and patient advocacy groups. It is

expected that by year three the new laws will be effective. This will pave way for the establishment

of infrastructure for regulation of medical devices and diagnostics. As the legal framework is being

25

reviewed or developed, NMRAs will continue to use their existing mandates to implement the

project.

In years one and two regional and international experts will develop harmonized framework for

premarket, market and post-market controls.

In year three regional experts with the support of international experts will initiate collaborative pre-

market assessments, quality audits of manufacturers, import controls, control of promotion, post

market surveillance activities, adverse events monitoring and information management. The joint

activities will continue through years four and five. These joint activities as opposed to national level

activities will pave the way for mutual recognition of regulatory decisions and reduce duplication of

effort. Collaboration will also translate to improved efficiency in regulation and expertise through

information sharing.

7.0 MONITORING AND EVALUATION

Monitoring and evaluation (M&E) will play a key role in ensuring that the project implementation is

in line with the set project objectives. It will generate information and provide lessons during

implementation that will be essential for improving strategy and ensuring that the project has an

impact on the health of the people of the EAC region. Within the project, M&E will serve three main

purposes including:

i. provide the project office, focal points and other relevant stakeholders with relevant

information and feedback as implementation of project unfolds;

ii. synthesize the lessons learned during implementation and using them for improving the project

delivery process;

iii. assess the progress of NMRAs in the harmonization process and proposing next steps.

The Senior Health Officer (Medical Devices and In Vitro Diagnostics) will be responsible for M&E

activities within the project at all levels. They will be assisted by all the project staff at EAC

Secretariat and NMRAs.

A situational analysis studies will be commissioned by EAC during project development with the aim

of establishing the situation on regulation of medical devices and diagnostics within the EAC region.

This study will be used to provide baseline information on the set indicators in the project

26

framework. A monitoring and evaluation system will be developed based on the project framework

and the milestones table that will enable the project management team collect relevant information

for improving action and documenting lessons learnt. The main focus in M&E system will be:

i. Process monitoring which will mainly centre on continuous tracking of activities and

milestones. This will be key for project management with timely information on the

performance of the project for facilitating improvement of action where necessary

ii. Output monitoring and evaluation which will mainly focus on tracking progress in the

achievement of project outputs. The information regarding outputs will be collected during

both continuous monitoring processes and the midterm evaluation. The midterm evaluation

will also be the main reflection point on the progress being made and the likelihood of the

project to achieve its set targets.

iii. Outcome and impact monitoring which will mainly focus on assessing if the project has

achieved its set immediate and intermediate outcomes. The end of project evaluation will

that will be conducted at the end of the project will be a key for providing this assessment

data.

In order to ensure that learning is internalized in the project implementation process, there will be

key learning activities that will be organized. These activities will provide a forum through which

project management team will be briefed on the progress being made in the implementation of

activities and achievement of outputs and outcomes. The bi-annual Project Steering Committee

meetings will be organized with the aim of providing feedback on the progress made in

implementation and to provide a way forward for improving action. The Project Coordinator in

collaboration with the national focal points through the heads of the NRAs will produce project

quarterly, biannual and annual reports that will be presented to the Project Steering Committee

during their meetings. Lessons learnt will also be documented for providing lessons and improving

actions.

8.0 SUSTAINABILITY

The EAC harmonized regional medical devices and diagnostics regulation system will be sustained

through the existing organisational and institutional framework of the EAC Secretariat and Partner

States’ NMRAs. Financial resources to be mobilized will be used to support the project for the five

years of its duration. Subsequently, the cost of maintaining on-going project activities and personnel

will be borne by the EAC Secretariat and the Partner States’ NMRAs. The project staff at EAC

27

Secretariat and at the NMRAs will be absorbed and retained as regular staff in order to

institutionalize the harmonized regulatory systems.

9.0 CITATIONS

1. Rugera SP, McNerney R, Poon AK, et al. Regulation of Medical Diagnostics and Medical Devices in

the East African Community Partner States. . Under review.

2. McNerney R, Sollis K, Peeling R. Improving access to new diagnostics through harmonised

regulation: priorities for action. Afr J Lab Med 2104;3(1).

3. Peeling R, McNerney R. Increasing access to diagnostics through technology transfer and local

production. Geneva: WHO, 2011.

4. Ecclestone R. A model regulatory program for medical devices: an international guide. In:

Hernández A, ed. Washington, D.C.: World Health Organization and United States Food and

Drug Administration, 2001.

28

10.0 PROJECT FRAMEWORK AND BUDGET

29

Objective Year 1 Year 2 Year 3

Responsible Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11 Q12

1 To establish and

strengthen the legal

and policy framework

on regulation of (i)

medical devices and (ii)

in vitro diagnostics

within each of the

Partner States

i. Assessment report of

the existing policy and

legal framework

ii. Policy framework

iii. Legal framework

iv. For each Partner State

an established

regulatory body, or a

business plan and

timelines for

establishment of a NRA,

with capacity for

harmonized regulation

of medical devices and

in vitro diagnostics.

2 To build and improve

human resource and

infrastructural capacity

for the regulation of (i)

medical devices and (ii)

in vitro diagnostics

amongst the Partner

i. Equipped and furnished

offices

ii. IT support and web

pages established

iii. Recruited staff

iv. Strategy for human

resource retention and

30

States career development

v. Report of training needs

and identification of

partners to conduct

training

vi. Number of staff trained,

level and scope of

training.

3 To establish criteria for

laboratories to

undertake post market

surveillance activities

for in vitro diagnostics.

The criteria to include

indicators of quality

and good practice, and

timely access to

appropriate samples.

i. Published criteria for

laboratories to perform

post-market evaluation

of IVD for selected major

diseases (e.g. HIV,

malaria)

4 To establish an EAC

network of

laboratories accredited

for post market

surveillance of in vitro

diagnostics for major

i. Register of laboratories

ii. A common information

management systems

for post market

surveillance, to include

web based platforms in

31

diseases and

implement common

information

management systems

for post market

surveillance in each of

the EAC Partner States’

NRAs and the East

African Community

Medicines and Food

Safety Commission

(EACMFSC).

each Partner State

5 To implement regional

harmonized regulatory

framework and mutual

recognition for

regulation of (i)

medical devices and (ii)

in vitro diagnostics

based on risk

classification

i. Published documents,

and web-based

dissemination of risk

classification rules and

common definitions for

medical devices and IVD

ii. A strategy to determine

risk classification for

novel

technologies/products

seeking market entry.

iii. List of EAC Partner

32

States priority IVDs and

medical devices, by type

and disease and risk

classification

iv. Model regulations,

guidelines and standard

operating procedures for

regulation of medical

devices and IVDs

v. Recommendations for

recognizing regulatory

decisions of stringent

NRAs or WHO

Prequalification Program

and process for

expedited review, if

appropriate.

vi. Common post market

surveillance strategy

vii. Mechanism for

correction and recall

viii. Report on progress

towards ISO 90001

certification of National

33

Regulatory Authorities

of Partner States

ix. Roadmap

6 To implement a

common information

management systems

for registration of (i)

medical devices and (ii)

in vitro diagnostics in

each of the EAC

Partner States’ NRAs

i. List of common

elements to be captured

ii. A platform for

information sharing

iii. Guidelines and standard

operating procedures for

analysing and sharing

information

7 To work in

collaboration with

IMDRF, PAHWP, AHWP

and other international

organisations to

promote access to safe

and affordable medical

devices and diagnostics

though harmonized

regulation.

i. Attendance at IMDRF

meetings and other

international fora,

including meetings of

the PAHWP.

8 To work in

collaboration with

the London School of

i. To establish a forum

for collaboration,

technical exchanges

34

Hygiene and Tropical

Medicine and other

partners to establish

mechanisms to

ensure that

regulatory decisions

are based on strong

and clear science

and that regulatory

science keeps pace

with technological

innovation

on new science and

technologies among

regulators, healthcare

professional groups,

academia and

consumers.

ii. To foster mechanisms

for harmonized

assessment of new

technologies and

develop regulatory

science in keeping

with technological

innovation

9 To inform the public

and interested parties,

including

manufacturers and

distributors of medical

products, of the

harmonised regulation

of medical device and

i. Website and

advocacy materials

ii. Articles in the media

iii. Articles in

newsletters

35

diagnostics in EAC

Partner States.

36

37

APPENDIX I Elements of regulation of medical devices and diagnostics

The table below contains a summary of internationally recognized elements of regulation of medical

devices and diagnostics.

Premarket controls

Policy and Legal Framework A legal framework allows national regulatory control authorities to

administer and enforce the regulations. Regulations may pertain to

safety, performance, quality, good manufacturing practices, labelling,

advertising and other such matters deemed in the interest of public

health protection. For a regulatory system to be effective it must be

enforceable in both the public and private healthcare sector.

Definitions, nomenclature

and Unique device identifier

(UDI)

Clear definition of terms and nomenclature is required to inform the

regulations. Adherence to internationally accepted definitions, such as

those proposed by IMDRF/GHTF, and Global Medical Device

Nomenclature (GMDN) advances harmonisation efforts and reduces

barriers to trade.

Risk Based classification Activities undertaken by or on behalf of the regulator should be

proportional to the product under consideration where products are

stratified according to the risk (or hazard) they pose to public or

personal health according to the intended use. References:

GHTF/SG1/N77:2012;GHTF/SG1/N045:2008

Premarket conformity

assessment

To assess quality, safety, performance, benefits and risks. The

conformity assessment activity will be determined by the risk class of

the medical device or diagnostic. References: GHTF/SG1/N78:2012;

GHTF/SG1/N046:2008; GHTF/SG1/N063:2011; GHTF/SG1/N011:2008

Manufacturing controls To verify conformance with manufacturing standards and validate

quality assurance. Auditing of manufacturing processes may include site

inspection. The IMDRF single audit program (MD-SAP) will provide for a

single audit to be undertaken by a recognised competent organisation

using agreed standards of inspection.

Standards International standards are tools to assure the safety, quality and

performance of products or services. Regulatory Authorities (RA)

should establish a mechanism for recognizing international standards to

38

provide manufacturers with a method of demonstrating conformity

with the Essential Principles. Refer GHTF/SG1/N044:2008

Registration and Listing Registration provides information on the parties that are or will be,

supplying medical devices and diagnostics to the market that is within

the NRA’s jurisdiction. Refer GHTF/SG1/N065:2010

Provisions for access under

exceptional circumstances.

This may include provisions for wavering of fees or specific regulatory

requirements, based on exceptional needs such as response to a novel

disease with high public impact. The provisions may be of a permanent

nature (e.g. lower fees where the product is needed for a limited

number of patients) or time limited, as is the case of needing a novel

device during an emergency.

Marketing Controls

Advertising control To avoid inappropriate marketing of a device, or propagation of

misleading claims regarding product effectiveness.

Labelling Controls (also can

be considered in premarket

controls)

Provisions to avoiding misbranding, which includes but is not limited to,

information that is misleading, insufficient or false. Also providing for

clear and unambiguous instruction for use.

Market entry controls Conditions under which devices can be offered for sale, and intended

use.

Post-marketing Controls

Medical Devices and

diagnostics post market

surveillance

Active and/or passive system to maintain vigilance over marketed

products to ensure their continued safety, quality and performance, as

well as on going regulatory compliance by manufacturers or suppliers

after obtaining market clearance. References:

GHTF/SG2/N79R11:2009;GHTF

SG2/N47R4:2005;GHTF/SG2/N61R4:2004;GHTF/SG2/N33R11:2002

Device adverse event

reporting

A method for information sharing among users and national health

authorities of similar devices is vital to preventing additional adverse

incidents and their unwanted health effects. References:

SG2 N87:2012; GHTF/SG2/N54R8:2006;

GHTFSG2/N68R3:2005;GHTF/SG2/N31R8:2003;

39

GHTF/SG2/N32R5:2002; GHTF/SG2/N36R7:2003; GHTF-SG2-N008R4;

GHTF/FD: 99-7

Corrections/Recall A means by which corrections can be made and where there is a risk to

public health substandard products can be removed from the market.

Reference: GHTF SG2/N57R8:2006

Information Exchange Establishment of systems to ensure timely exchange in confidence, of

adverse events and other aspects associated with quality, safety and

performance of a medical device or diagnostic. References: GHTF/SG2/

N38R19:2009; GHTF/SG2/N9R11:2003; GHTF/SG2/N20R10:2002

Post market inspections Mechanism to inspect as required in response to a concern regarding

the quality, safety and performance of a medical device or diagnostic.

See references from premarket controls.

Penalties Legislation should include relevant and appropriate penalties to ensure

that manufacturers and suppliers comply with the regulation.

Premarket controls

Policy and Legal Framework A legal framework allows national regulatory control authorities to

administer and enforce the regulations. Regulations may pertain to

safety, performance, quality, good manufacturing practices, labelling,

advertising and other such matters deemed in the interest of public

health protection. For a regulatory system to be effective it must be

enforceable in both the public and private healthcare sector.

Definitions, nomenclature

and Unique device identifier

(UDI)

Clear definition of terms and nomenclature is required to inform the

regulations. Adherence to internationally accepted definitions, such as

those proposed by IMDRF/GHTF, and Global Medical Device

Nomenclature (GMDN) advances harmonisation efforts and reduces

barriers to trade.

Risk Based classification Activities undertaken by or on behalf of the regulator should be

proportional to the product under consideration where products are

stratified according to the risk (or hazard) they pose to public or

personal health according to the intended use. References:

GHTF/SG1/N77:2012;GHTF/SG1/N045:2008

Premarket conformity

assessment

To assess quality, safety, performance, benefits and risks. The

conformity assessment activity will be determined by the risk class of

the medical device or diagnostic. References: GHTF/SG1/N78:2012;

40

GHTF/SG1/N046:2008; GHTF/SG1/N063:2011; GHTF/SG1/N011:2008

Manufacturing controls To verify conformance with manufacturing standards and validate

quality assurance. Auditing of manufacturing processes may include site

inspection. The IMDRF single audit program (MD-SAP) will provide for a

single audit to be undertaken by a recognised competent organisation

using agreed standards of inspection.

Standards International standards are tools to assure the safety, quality and

performance of products or services. Regulatory Authorities (RA)

should establish a mechanism for recognizing international standards to

provide manufacturers with a method of demonstrating conformity

with the Essential Principles. Refer GHTF/SG1/N044:2008

Registration and Listing Registration provides information on the parties that are or will be,

supplying medical devices and diagnostics to the market that is within

the NRA’s jurisdiction. Refer GHTF/SG1/N065:2010

Provisions for access under

exceptional circumstances.

This may include provisions for wavering of fees or specific regulatory

requirements, based on exceptional needs such as response to a novel

disease with high public impact. The provisions may be of a permanent

nature (e.g. lower fees where the product is needed for a limited

number of patients) or time limited, as is the case of needing a novel

device during an emergency.

Marketing Controls

Advertising control To avoid inappropriate marketing of a device, or propagation of

misleading claims regarding product effectiveness.

Labelling Controls (also can

be considered in premarket

controls)

Provisions to avoiding misbranding, which includes but is not limited to,

information that is misleading, insufficient or false. Also providing for

clear and unambiguous instruction for use.

Market entry controls Conditions under which devices can be offered for sale, and intended

use.

Post-marketing Controls

Medical Devices and

diagnostics post market

Active and/or passive system to maintain vigilance over marketed

products to ensure their continued safety, quality and performance, as

41

surveillance well as on going regulatory compliance by manufacturers or suppliers

after obtaining market clearance. References:

GHTF/SG2/N79R11:2009;GHTF

SG2/N47R4:2005;GHTF/SG2/N61R4:2004;GHTF/SG2/N33R11:2002

Device adverse event

reporting

A method for information sharing among users and national health

authorities of similar devices is vital to preventing additional adverse

incidents and their unwanted health effects. References:

SG2 N87:2012; GHTF/SG2/N54R8:2006;

GHTFSG2/N68R3:2005;GHTF/SG2/N31R8:2003;

GHTF/SG2/N32R5:2002; GHTF/SG2/N36R7:2003; GHTF-SG2-N008R4;

GHTF/FD: 99-7

Corrections/Recall A means by which corrections can be made and where there is a risk to

public health substandard products can be removed from the market.

Reference: GHTF SG2/N57R8:2006

Information Exchange Establishment of systems to ensure timely exchange in confidence, of

adverse events and other aspects associated with quality, safety and

performance of a medical device or diagnostic. References: GHTF/SG2/

N38R19:2009; GHTF/SG2/N9R11:2003; GHTF/SG2/N20R10:2002

Post market inspections Mechanism to inspect as required in response to a concern regarding

the quality, safety and performance of a medical device or diagnostic.

See references from premarket controls.

Penalties Legislation should include relevant and appropriate penalties to ensure

that manufacturers and suppliers comply with the regulation.

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ANVISA:

1. Good Distribution Practice and Good Storage Practice for both Medical Devices and IVDs in

Portuguese.

2. Post-marketing surveillance documents – active technical surveillance implemented by a

network of 195 hospital/labs

Pilots in PAHWP:

New WHO Classification for IVDs

WHO PQ dossier for CD4

Joint review of CD data

Post-marketing surveillance –WHO Global Fund and ASLM involved

Meetings in 2014:

1. PAHWP joint data review workshop: July 3-4 in Arusha, Tanzania

2. AHWP: Sept 2-3 in Taiwan ; Annual AHWP meeting Nov 18-21 in Korea

3. ALADDIV: Week of Oct 27 in Brasilia

4. PAHWP: 3rd African Regulatory Forum Nov 29-30 in Cape Town (preceding ASLM Congress)

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