How to apply for the listing of in vitro diagnostic ... to apply for the listing of in vitro...

www.mdco.gov.hk 1MDCO (All rights reserved)

Workshop for Medical Device Administrative Control System

How to apply for the listing of in vitro diagnostic medical device (IVDMD)

Department of Health Medical Device Control Office


Workshop Agenda

Medical Device Administrative Control System (MDACS)

Local Responsible Person（LRP） Importer Classification of IVD Medical Devices Break How to prepare application document Q&A


Medical Device Administrative Control System

(MDACS)


Voluntary system To be eventually superseded by a statutory system Goal of the MDACS

To raise the public’s awareness of the use of safe medical devices To enable traders to familiarize themselves with the future

mandatory requirements To provide an opportunity to collect more information and feedback

from the industry as a reference to fine tune the long-term regulatory framework

(Source: Consultation Document dated July 2003 entitled “Regulation of Medical Devices”)

Medical Device Administrative Control System


Scope of the MDACS Listing System

Medical Device (Class II - IV) (applications to be submitted by LRP)

Local Manufacturer Importer Conformity Assessment Bodies (CAB) In Vitro Diagnostic Medical Devices (Class D)

Adverse Incident Reporting System If a reportable incident concerning a listed device happens

in Hong Kong, it must be reported by the LRP to MDCO. (Guidance Notes GN-03)

www.mdco.gov.hk

Implemented by phases

Implementation Progress

Phase I: Listing of Class IV devices Phase II: Listing of Class II & III devices Phase III: Conformity Assessment Body Recognition Scheme Phase IV: Listing of local manufacturers Phase V: Listing of importers Phase VI: Listing of Class D IVDMD

Phase I Phase II Phase III Phase IV Phase V Phase VI

26 NOV 04 14 NOV 05 13 OCT 06 23 MAR 07 17 JUL 07 1 DEC 09Statutory

System

6


Information from MDCO website(www.mdco.gov.hk)

Related Guidance Notes, Code of Practice and Technical References http://www.mdco.gov.hk/english/mdacs/mdacs_gn/mdacs_gn.html

Application Forms http://www.mdco.gov.hk/english/mdacs/mdacs_af/mdacs_af.html

The List of Medical Deviceshttp://search.mdco.gov.hk/english/sd/sd_ld/sd_ld.php

Asian Medical Device Nomenclature System (AMDNS)http://search.mdco.gov.hk/english/sd/sd_amdn/sd_amdn.php

http://www.mdco.gov.hk/english/mdacs/mdacs_gn/mdacs_gn.html�

http://search.mdco.gov.hk/english/sd/sd_amdn/sd_amdn.php�


Issued DocumentsGuidance Notes Reference Document

Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System

GN-00

Overview of the Medical Device Administrative Control System GN-01

Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System

GN-01S

Guidance Notes for Listing Class IV Medical Devices GN-02

Guidance Notes for Adverse Incident Reporting by Local Responsible Persons

GN-03

Conformity Assessment Framework and Conformity Assessment Bodies

GN-04

Guidance Notes for Listing Class II/III Medical Devices GN-05

Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices GN-06

Guidance Notes for Listing of Importers of Medical Devices GN-07

Guidance Notes for Listing of Local Manufacturers GN-08


Issued DocumentsTechnical Reference Reference Document

Principles of Conformity Assessment for Medical Devices TR-001

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

TR-002

Classification Rules for Medical Devices TR-003

Essential Principles of Safety and Performance of Medical Devices TR-004

Additional Medical Device Labelling Requirements TR-005

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification TR-006

Code of Practice Reference Document

Cope of Practice for Local Responsible Persons COP-01

Cope of Practice for Conformity Assessment Bodies COP-02

Cope of Practice for Listed Local Manufacturers COP-03

Cope of Practice for Listed Importers of Medical Devices COP-04


Relevant InformationDescription Reference Document

Scope of the MDACS GN-01 Section 3.2.1

Classification Rules of Medical Devices

GN-01 Appendix 1 and Section 2

Designation of LRP GN-01 Section 3.1(b), 4.3, 4.6 and Appendix 5

Responsibilities of LRP GN-01 Section 3.1(b) and 4.4; COP-01

Application for the listing of Class IV medical devices

GN-01 Section 5; GN-02

Application for the listing of Class II and III medical devices

GN-01 Section 5; GN-05

Definitions of family, series and system of medical devices

GN-02 Section 6 Item 3001; GN-05 Section 6 Item C002


Relevant InformationDescription Reference

Requirements on adverse incident reporting

GN-03

Essential Principles of Safety and Performance of Medical Devices

GN-01 Appendix 2

Labeling requirements GN-01 Section 4.4.13 and Appendix 3; COP-01 Section 3.1.2

Conformity Assessment Framework (CAB Recognition Scheme)

GN-04, TR-001 & TR-002

Application for the Listing of Importer GN-07; COP-04

Application for the Listing of Local Manufacturer

GN-08, COP-03


Local Responsible Persons(LRP)

www.mdco.gov.hk

Importance of LRP

The need for LRP To serve as communication hub among users,

manufacturer, importer and government To ensure the safe and efficacious use of the

medical devices To provide quality services to the users

MDACS requires each class II/III/IV medical device and class D IVDMD must be listed by LRPs

17


Who can be an LRP?

A company incorporated in Hong Kong or a company or natural person with business registration in Hong Kong; and who is

Itself the manufacturer of the device or supported by the manufacturer of the device (in the latter case the manufacturer must designate the LRP in writing)


Sample Letter for Designating a Local Responsible Person(GN-01 Appendix 5)


Relationship between Manufacturer and LRP

HKSAR

Overseas Manufacturer

Branch

Local Manufacturer

Two types of Manufacturer: “Local” and ”Overseas”Manufacturer can “designate” LRPs or becomes LRP by itself

HKSAR

LRP

Overseas Manufacturer

designate

Figure 1 Figure 2


Relationship between Manufacturer and LRP

Type of Manufacturer By Itself By Designation

Local Manufacturer

Overseas Manufacturer(branch in Hong Kong)

(H.K. Branch)

Overseas Manufacturer(without branch in Hong Kong)


Responsible Person for Listed Medical Devices

Designed as LRP

Submit Application

Listed Medical Devices

LRP is responsible for the listed medical devices

(provide all required document and samples)


Responsibilities of LRP

Communications Hub

•Application for listing medical devices

•Efficient communication channels

•Reporting changes

•Making records available for inspection

•Maintain distribution records

Quality of Services

•Maintenance and services arrangements

•Compliant handling

Safe and Efficacious

•Managing reportable adverse incidents in Hong Kong

•Product alerts, modifications and recalls

•Tracking of specific medical devices


Obligations of LRPEffective communication

channels (Communicate with the users,importers, public and thegovernment and to manage pre-market and post-market matters)

Distribution records (Maintain an updated list of importers and distribution records of devices imported)

Other obligations(Notify the MDCO of any changes to the information submitted)

Making records available for inspection

(E.g. the originals or certified copies of records and documents)

Obligations of LRP


Importers of Medical Devices


Importer of Medical Devices

Importer means:

A legal or natural person who brings or entrustothers to bring medical devices that fall withinthe scope of MDACS into Hong Kong fordistribution or use in Hong Kong

But does not include any person who isemployed or engaged by such person to carrysuch products into Hong Kong


Importer of Medical Devices

Required listing devices Not required listing devices

“Listing of Importer”(voluntary system)

Importer(i) A legal or natural person: Business

Registration certificationIndividual : Identification document

(ii) Copy of documented procedures


Obligations of Listed Importers

Establishment of Procedures

(Distribution records, handlingcomplaints, recalls and advisorynotices, and reportable adverseincidents)

Requirements in Respect of Advertisement, Promotional Materials etc.

Other obligations(E.g. Notifying the MDCO of any changes to the information submitted)

Making Distribution Records and relevant documents available for inspection

Obligations of Listed Importers


End of Session


Classification of In Vitro Diagnostic Medical Devices (IVDMD)


Classification of IVDMD Risk Level – A, B, C, D

Class D – Highest risk level (high individual risk and high public health risk)

Risk factors Intended uses of IVDMD Features of IVDMD

Technical Reference TR-006: Principles of IVDMD Classification

The device should be allocated to the highest class indicated when more than one of the classification rules apply to the device


Classification of IVDMD Definition of IVDMD

a device, whether used alone or in combination, intended by the manufacturer for in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes

This is includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles


Classification of IVDMD

Class Individual risk

Public health risk

D High High

C High Medium

B Medium Low

A Low Low


Classification of IVDMD: Jargons

Transmissible Agent Transfusion, Transplantation Genetics, Genes, Fetus ST: Self Testing Near-Patient Testing Preliminary Vs Follow-up

www.mdco.gov.hk

Rule 1 Part 2 -> Class D

To detect the presence of, or exposure to, a transmissible agent that causes a life-threatening, often incurable, disease with a high risk of propagation E.g. Tests to detect infection by HIV, HCV,

HBV, HTLV

36

www.mdco.gov.hk

Rule 1 Part 1 & Rule 2 Part 1 -> Transfusion / Transplantation

[R1#1] To detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs in order to assess their suitability for transfusion or transplantation -> Class D

[R2#1] To be used for blood grouping or tissue typing to ensure the immunological compatibilityof blood, blood components, cells, tissues or organs that are intended for transfusion or transplantation -> Class C E.g. HLA

37

www.mdco.gov.hk

Rule 2 Exceptions -> Class D

[R2 exception] blood grouping or tissue typing except for ABO system [A(ABO1), B(ABO2), AB(ABO3)], Rhesus System [RH1(D), RH2(C), RH3(E), RH4(c), RH5(e)], Kell System [Kell(K)], Kidd System [JK1(Jka), JK2(Jkb)] and Duffy System [FY1(Fya), FY2(Fyb)] -> Class D

38

www.mdco.gov.hk

Rule 3: related to general transmissible disease -> Class C Sexually transmissible diseases Congenital disorders in fetus, genetic testing,

Pre-natal screening of women Disease Staging, Cancer Diagnosis Levels of medicines, substances or biological

components (E.g. Cardiac markers) Viral Loads …

39

www.mdco.gov.hk

Rule 4: Self-Testing & Near-Patient Testing

[ST] result is not determining a medical critical status, or is preliminary and requires follow-up test -> Class B E.g. Pregnancy self-test, fertility testing, urine test

strips [ST] provides quantitative result and does not

require follow-up test -> Class C E.g. Blood glucose monitoring

[Near-Patient Testing] determining blood gases and blood glucose -> Class C

40

www.mdco.gov.hk

Rule 5 – 7

[R5] Instruments intended by manufacturer specifically to be used for IVD procedures (most of clinical lab instruments) -> Class A

[R5] Specimen receptacles -> Class A [R7] Controls without a quantitative or

qualitative assigned value -> Class B [R6] Others -> Class B

41


Medical Device Control Office Department of Health Address： Rm 3101, 31/F, Hopewell Centre, 183

Queen’s Road East. Wanchai, HK Phone： 3107 8484Fax： 3157 1286Email： [email protected]： www.mdco.gov.hk

Contact Us

mailto:[email protected]�


(The content of this presentation serves as reference only. Please refer to Department of Health

for detailed of Medical Device Administrative Control System.)

Thank You!


How to prepare an application


Application form for the listing of

IVDMD

www.mdco.gov.hk 46


IVDMD

www.mdco.gov.hk


IVDMD

47



IVDMD

www.mdco.gov.hk 49


IVDMD

www.mdco.gov.hk 50


IVDMD

50

www.mdco.gov.hk 51


IVDMD

www.mdco.gov.hk 53

Documents in Submission FolderEncl. Information

Manufacturer A1 A copy of business registration certificate if the manufacturer has a registered place of business in HK

A2 A copy of certificate of quality management system

Local Responsible Persons

B1 A copy of business registration certificateB2 A copy of manufacturer’s designation letterB3 A copy of certificate of quality management

systemB4 A copy of documented procedures established

In Vitro Diagnostic Medical Devices

C1 Details of IVDMD e.g. make, model, accessories, manufacturing sites

C2 History of recalls, reportable adverse incidents, banning or post-market surveillance studies

www.mdco.gov.hk 54

Documents in Submission FolderEncl. Information

In Vitro Diagnostic Medical Devices

C3 Instructions for uses and special listing information C4 Batch verification (for Class D IVDMD only) (if any) C5 Conformity Assessment Certificate issued by CAB

recognized by MDCO (if any) C6 Test report or certificate and risk analysis

report/summary C7 Performance evaluation report

Marketing Approvals

D1 Marketing approvals obtained from Australia (TGA), Canada (Health Canada), EU, Japan (MHLW) and USA (FDA)Essential Principles Conformity Checklist MD-CCL (if any)

www.mdco.gov.hk

IVDMD in EU: European Council Directive 98/79/EC (I)

No classification rules 3 categories of IVDMD Annex II List A (IIA): the highest risk Annex II List B (IIB) Self-Testing (ST)

012355

www.mdco.gov.hk

IVDMD in EU: European Council Directive 98/79/EC (II)

Annex II List A (IIA) ~ Class D Reagents, test kits, calibrators, control

materials to determine ABO System, Rhesus System

[C, c, D, E, e], Anti-Kell System To detect, determine, quantify HIV [HIV1,

HIV2], HTLVI and HTLVII, HBV, HCV, HDV

56

www.mdco.gov.hk

IVDMD in Canada

Classification Rules (Class 1, 2, 3, 4) – Class 4 refers to the highest risk level

[Canada R1] to detect the presence of a transmissible agent that causes a life-threatening, often incurable, disease with a high risk of propagation

[Canada R5] to detect transmissible agents in blood, blood components, blood derivatives, cells, tissues or organs in order to assess their suitability for transfusion or transplantation -> Class III (without exceptions)

Canada Class 3 and 4 may refer to Class D under MDACS in HK

57

www.mdco.gov.hk

IVDMD in Australia

TGA (Australia) employs most of GHTF Classification Rules with Class 1, 2, 3 & 4 since 1 July 2010.

Only difference: IVDs used to test for transmissible agents included in the Australian National Notifiable Diseases Surveillance System (NNDSS) are in Class 3.

TGA Class 4 = HK Class D

58

www.mdco.gov.hk

IVDMD in HK – Two requirements

LRP’s documented procedure: Low temperature requirements of IVDMD during storage and transportation

Verification during IVDMD Batch Release (Batch Release Mechanism) Compulsory for devices fall into EC Annex II List A Documented procedures

59


Manufacturer

ISO 13485:2003

(A1, C1)

www.mdco.gov.hk

BR Certificate of LRP(B1) LRP MEDICAL SUPPLIES LIMITED

61


Designation Letter

(B2)


QMS certificate of LRP

ISO 9001

(B3)


Special Listing Information

(C3)

www.mdco.gov.hk 65

Marketing Approval –

USA FDA

(D1)

www.mdco.gov.hk 66


Canada HC

(D1)

www.mdco.gov.hk 67


Australia TGA

(D1)

www.mdco.gov.hk 68


Japan MHLW

(D1)


Declaration of Conformity

EC Design – Examination Certificate Annex IV Section 4 IVDDAnnex III Section 6 IVDD(ST)

EC Type Examination Certificate Annex V IVDD

Full Quality Assurance System Approval Certificate

Annex IV Section 3 IVDD

EC Verification (Testing Certificate) Annex VI IVDD

Production Quality Assurance System Approval Certificate

Annex VII IVDD

Marketing Approval – EU (D1)

IVDD: 98/79/EC Directive; ST: Self-Testing


Marketing Approval – EU

(D1)

Sample of DoC


Sample of Annex IV Cert

(Full Quality Assurance System)


(D1)


Sample of Design Exam Cert


(D1)


Q & A

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