5 Oct 2009 REGULATION AND ISSUES OF MEDICAL DEVICE INNOVATIONS

Medical Device BureauMINISTRY OF HEALTH MALAYSIA

Research Enrichment Seminar, USM Kelantan, 5 Oct 2009

Regulation and Issues of Medical Device Innovations/Inventions in Malaysia

REGULATION AND ISSUES OF MEDICAL

DEVICE INNOVATIONS/INVENTI

ONS IN MALAYSIA

REGULATION AND REGULATION AND ISSUES OF MEDICAL ISSUES OF MEDICAL

DEVICE DEVICE INNOVATIONS/INVENTIINNOVATIONS/INVENTI

ONS IN MALAYSIAONS IN MALAYSIAResearch Enrichment Seminar

Health Campus University of Science MalaysiaKota Bharu, Kelantan

5 October 2009

AHMAD SHARIFF HAMBALI [email protected] ●

Medical Devices Bureau, Ministry of Health MalaysiaLevel 5, No 26, Boulevard Plot 3C4, Precinct 3, 62675 Putrajaya ●

http://www.mdb.gov.my/

●

Tel: 603‐88850600

●

Fax: 603‐88850759/0760

mailto:[email protected]





CONTENTS CONTENTS CONTENTS •

Why regulate?

•

What is a medical device?•

What are the factors affecting safety & performance?

•

How medical device is regulated? Regulatory framework

•

Legislative support and enforcement•

Issues on innovations/inventions




CONTENTS CONTENTS CONTENTS ••

Why regulate?Why regulate?

•



•


•





Regulation and Issues of Medical Device Innovations/Inventions in Malaysia Regulation and Issues of Medical Device Innovations/Inventions in Malaysia

AIMS OF REGULATION

Ensure public health & safetyProvide assurance for quality, safety, performancePrevent defective & unsafe medical devicesTimely access to beneficial medical devices

Facilitate medical devices trade & industry

Rules-based environment for medical devices industryFacilitate trade & export




Essential Principles of Safety and Performance of Medical Devices

Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and where applicable, by virtue of the technical knowledge, experience, education or training of intended users, they will not compromise the clinical condition or safety of patients, or the safety and health of users, or other persons where applicable

-

GHTF 30/6/1999; WHO April 2001

BASIS OF REGULATION




The regulatory system should; expedite timely availability of and access to safe and beneficial medical devicesprevent sub-standard, unsafe and ineffective medical devices from entering the marketprovide a proportionate level of control according to the degree of risk, taking into account the benefits offered by the use of the device

GUIDING PRINCIPLES




The regulatory system should;incorporate all elements of control from design through disposal to ensure;

continued safety and quality; ongoing regulatory compliance after market clearance has been obtained

be in-line with global harmonization effort with some modifications to suit local circumstances

GUIDING PRINCIPLES





Why regulate?

••

What is a medical device?What is a medical device?•


•


•






The term “medical device” covers any products used in healthcare for

the diagnosis, prevention, monitoring or treatment of illness or handicap

but excludes drugs

What is a medical device?

DEFINITION OF MEDICAL DEVICE




Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a)

intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose (s) of;

diagnosis, prevention, monitoring, treatment or alleviation of disease;diagnosis, monitoring, treatment, alleviation of or compensation for an injury;investigation, replacement, modification, or support of the anatomy or of a physiological process;supporting or sustaining life;control of conception;disinfection of medical devices;providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and

b)

which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may

be assisted in its intended function by such means

GHTF/SG1-N29R16:2005: Information Document Concerning the Definition of the Term "Medical Device“

DEFINITION OF MEDICAL DEVICE




o A classification to categorize medical devices based on risk associated with the vulnerability

of the human body, the

technical design and the manufacture

of the medical device

o It uses a set of classification rules based on:•

intended use

•

duration of use (transient, short-term and long-term)

•

part of human body (non-invasive or invasive with respect to body orifices, surgically invasive interventions, central circulatory system, central nervous system)

CLASSIFICATION OF MEDICAL DEVICE




Devic

e Clas

s

Device Risk

Risk: Combination of the probability of occurrence of harm and the severity of that harm

Class A

Class B

Class C

Class D





Class Risk Level Device examples

A Low Simple surgical instruments, tongue depressor, liquid-in-glass thermometer, examination light, simple wound dressing, oxygen mask, stethoscopes, walking aids

B Low-

Moderate

Hypodermic needles, suction equipment, anesthetic breathing circuits, aspirator, external bone growth simulators, hearing aids, hydrogel dressings, patient controlled pain relief, phototherapy

unit, x-ray films

C High-

Moderate

Lung ventilator, orthopedic implants, baby incubator, blood oxygenator, blood bag, contact lens disinfecting/cleaning products, deep wound dressing, defibrillator, radiological therapy equipment, ventilator

D High Pacemakers and their leads, implantable defibrillators, implantable infusion pumps, heart valves, inter-uterine contraceptive devices, neurological catheters, vascular prostheses, stents






Why regulate?

•

What is a medical device?••

What are the factors affecting What are the factors affecting safety & performance?safety & performance?

•


•






PRE-MARKETDesign and development

The concept, design, construction and testing (incl clinical trials) require scientific scrutiny to minimize unwarranted risks

ManufacturingManufacturing processes need to be properly managed and controlled to prevent inconsistency in the quality of products

Packaging and labeling Appropriate packaging is important

especially in delivering clean, sterile and protected medical devices to the point of useto prevent damage during transportation and handling

Labeling (incl hazard warnings and instructions for use) is crucial in identifying a medical device and specifying instructions for its proper use Mislabeling may result in serious consequences to the user

FACTORS AFFECTING SAFETY & PERFORMANCE




PLACEMENT ON-MARKETAdvertising

Advertisement can create expectations and influence the belief in the capabilities of a medical deviceMisleading advertisement may deprive the patient of more appropriate treatment and could lead to patient or user injury

Sale/distributionThe sale of medical devices by the vendor leads to the device being put into actual useThere is a higher risk of exposing the public to low quality or ineffective devices if the distributors are not subject to regulation





POST-MARKETUsage

Device failure may occur even no design/manufacturing defects due to; unfamiliarity with technology or operating procedurethe use of device for clinical indications outside the specified scope

Re-use of single-use devices, use of devices contrary to instructions, use of devices without proper control or precautions can be dangerous

Installation and maintenance/calibrationSome devices require proper installation (incl testing and commissioning) Inappropriate or lack of testing and maintenance/calibration of such devices may jeopardize safety and performance

DisposalDisposal of certain types of devices should follow specific safety rules, eg devices that are contaminated after use or devices that contain toxic chemicals






Why regulate?

•



••

How medical device is regulated? How medical device is regulated? Regulatory frameworkRegulatory framework

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PRE-MARKET POST-MARKET

•

Design & development •

Manufacturing, importing•

Packaging, labeling, storage

•

Installation, T&C•

Usage, maintenance•

Decommission, disposal•

Surveillance, vigilance•

Distribution & sale •

Advertising

Medical device life-cycle

SCOPE OF REGULATION

PLACEMENT ON-MARKET




DEVICEto ensure quality, safety

& effectiveness of medical devices

REPRESENTATIONto ensure correct

product representation

USEto ensure medical devices in use

continue to be safe & effective

ELEMENTS OF REGULATION




Pre-market review (review of submiss ion, test ing ,

cl inical evidence, audit)

a p p o i n t m e n t o f C A B

E s t a b l i s h m e n t

l i c e n s i n g ,MD reg i s t r a t ion ,

a d v e r t i s e m e n t c o n t r o l

Usage & maintenance

control, post-market

surveillance & vigilance, aud i t s , en forcement

REGULATORY ACTIVITIES

PRE-MARKET POST-MARKETPLACEMENT ON-MARKET




To ensure; product safety & performance; appropriate manufacturer’s quality systemappropriate post-market surveillance

Done via the review of;technical documentation (incl testing & audit)declaration of conformityquality management systempost-market surveillance system

PRE-MARKET CONTROL




Licensing of establishments dealing with MD is crucial in MD controlRegistration of MD demonstrates that it has undergone the scrutiny and complied with essential requirements for safety and performanceDone in conjunction with CAB

PRE-MARKET CONTROL




To identify “which” establishment dealing with “what” medical devicesManufacturers and local representatives (of imported products) will be licensedLocal representative should maintain linkage and obtain support of manufacturer if requiredEnables regulator to;

track the establishment when difficulty arisescarry out inspections to ensure compliance

PLACEMENT ON- MARKET CONTROL




Establishments are required to perform post-market obligations as one of the licensing requirementsAdvertisement control is performed to;

ensure correct product representation prevent misleading/fraudulent advertisements or claims that may lead the user or public to purchase an inappropriate medical device

PLACEMENT ON- MARKET CONTROL




To ensure continued safety and quality as well as ongoing regulatory compliance of medical devices after market clearancePre-market control cannot predict all devices failures/incidents arising from their use Two major activities to be performed;

post-market surveillanceadverse event reporting

POST-MARKET CONTROL




What is post-market surveillance?A post-market data collection system especially for high-risk medical devicesDone as a condition for product approval and to re-affirm product safety

What is adverse event reporting?A timely dissemination of information

to prevent recurrence of similar incident to ensure timely intervention of adverse incident and necessary remedial action

POST-MARKET CONTROL




Manufacturer/representative should;report adverse incidents that suggest that death or serious injury of a patient has been caused/contributed by the use of medical device investigate and carry out follow-up actions, eg product recall, and report the results to the authority

Healthcare professionals are encouraged to notify manufacturer/representatives of adverse incidents

POST-MARKET CONTROL




What is quality system? A system to identify organizational structure, resources, responsibilities, procedures, processes, required to implement quality management

Why is it important?strict QA on the production of medical devices reduces the likelihood of non-conforming products ensures consistency in the quality of a deviceprovides basis for greater reliability in safety & performance

QUALITY SYSTEM




Quality system is subject to regulator’s audits, management review, corrective and preventive measures to maintain product quality

QUALITY SYSTEM




What is the importance of the use of standards in regulatory system?

To demonstrate conformance to essential principles of safety and performance;

conformity to product standardsconformity to process standards; and conformity to management standards

THE USE OF STANDARDS




Why the use of standards is essential? The use of (international) standards helps in

improving productivity improving market competitiveness improving export capability reducing costsimplifying regulatory processpromoting international harmonization

THE USE OF STANDARDS





Why regulate?

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•


••

Legislative support and Legislative support and enforcementenforcement

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The regulatory system is supported by appropriate legislations;

Medical Device Authority Act to provide for the establishment of an appropriate organization for the implementation and enforcement of medical device regulatory systemMedical Devices Act to provide for the establishment, implementation and maintenance of a system of control related to performance and safety of medical devices

LEGISLATIVE SUPPORT




ENFORCEMENT Enforcement provisions and powers

conferred under the ActInvestigation, enforcement powersProsecutionPublic disclosureOffence by body corporate, partner, agent or servantPower to require information, to take sample Power to compoundPower to make regulationsetc





Why regulate?

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•


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Legislative support and enforcement••

Issues on innovations/inventionsIssues on innovations/inventions




Patients and medical community expect and demand timely access to new and latest medical technologiesResearchers expect patients to be more interested, more informed, and more active about making health care choicesMedical innovation requires contributions of a diverse array of scientific and engineering expertise

CHALLENGES TO INNOVATIONS AND REGULATOR’S MISSION




The issue is “Can the regulatory system meet these expectations?”The regulator’s mission is to protect public health and safety

ensuring medical devices safe & effective facilitating timely access to innovative medical devices

The main issue is the definition of value (ie safety and effectiveness of the innovative medical device) and the acceptable evidence to prove that value





The challenge is to develop an effective and efficient system

to ensure clinical trials, product reviews and approvals are conducted at the lowest cost and in the most efficient & effective way to move cutting-edge discoveries from the lab bench into clinical trials and into the market in a timely manner





Pre-requisites of an effective and efficient system

Competent human resourceSupporting activitiesTransparent and predictable regulationFinancial resourceHarmonization with the rest of the worldGreater collaboration & coordination between various professionals and various sectors

ANDCHALLENGES TO INNOVATIONS




Policy and regulatory framework – based on global harmonized systemLegal support – Act, regulations, guidelinesRegulatory system under development –conformity assessment, products, establishmentsCapacity and capability – regulator, industrySupport activities – standards, test labs, CABInteragency collaboration Global harmonization – www.ghtf/org, www.ahwp.info, www.accsq-mdpwg.org

CURRENT STATUS

http://www.ghtf/org

http://www.ahwp.info/

http://www.accsq-mdwg.org/




Thank you for your

attention

Thank you for your

attention

Please visit our website

www.mdb.gov.myor

visit us at

Medical Devices Bureau, Ministry of Health Malaysia, Level 5, No 26, Boulevard Plot 3C4, Precinct 3, 62675 Putrajaya


5 Oct 2009 REGULATION AND ISSUES OF MEDICAL DEVICE INNOVATIONS

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