Application for Listing of In Vitro Diagnostic (IVD ... · Medical Device Administrative Control System ... Performance of Medical Devices Labeling requirements GN-01 Section 4.4.13

Workshop for Workshop for

Application for Listing of In Vitro Application for Listing of In Vitro Diagnostic (IVD) Medical DevicesDiagnostic (IVD) Medical Devices

Medical Device Control OfficeMedical Device Control OfficeMedical Device Control Office Medical Device Control Office Department of Health Department of Health

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

Rev. 2016-05-16

Workshop AgendaWorkshop AgendaWorkshop AgendaWorkshop Agenda

Medical Device Administrative Control System (MDACS)

Local Responsible Person（LRP）

Importer Importer Classification of IVD Medical Devices How to prepare application document Q&A Q&A


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Medical Device Administrative C t l S tControl System

(MDACS)(MDACS)


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Background Background gg Existing control

No specific legislation to regulate the i t ti l f di l d i i HKimportation or sale of medical devices in HK.

But some medical devices may be regulated by existing pieces of legislation g y g p gsuch as the Pharmacy and Poisons Ordinance, Radiation Ordinance, etc.

Jul 2003 Jul 2003 Consultation Document entitled “Regulation

of Medical Devices


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Medical Device Administrative Control System

Voluntary system

Medical Device Administrative Control System

y y To be eventually superseded by a statutory system Goal of the MDACS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 requirementsmandatory requirements To provide an opportunity to collect more information and feedback

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


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Scope of the MDACS Listing System

Medical Devices (Class II – IV) Medical Devices (Class II IV) In Vitro Diagnostic (IVD) Medical Devices (Class D) Local Manufacturer Importer Distributor

R iti f C f it A t B di (CAB) Recognition of Conformity Assessment Bodies (CAB) Adverse Incident Reporting System

If t bl i id t i li t d d i h If a reportable incident concerning a listed device happens in Hong Kong, it must be reported by the LRP to Medical Device Control Office (MDCO). (Guidance Notes GN-03)


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Implementation Progress Implementation Progress p gp g Phase I (Nov 2001): Listing of Class IV devices Phase II (Nov 2005): Listing of Class II & III devices Phase II (Nov 2005): Listing of Class II & III devices Phase III (Oct 2006): CAB Recognition Scheme Phase IV (Mar 2007): Listing of local manufacturers Phase V (Jul 2007): Listing of importers Phase VI (Dec 2009): Listing of Class D IVDMD

Ph VII (A 2015) Li ti f Di t ib t Phase VII (Apr 2015): Listing of Distributors


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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 Deviceshtt // h d hk/ li h/ d/ d ld/ d ld hhttp://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 phphttp://search.mdco.gov.hk/english/sd/sd_amdn/sd_amdn.php


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www.mdco.gov.hkwww.mdco.gov.hk 10


11


12MDCO (All rights reserved)

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Issued DocumentsIssued DocumentsGuidance Notes Reference Document

Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System

GN-00Device Administrative System

Overview of the Medical Device Administrative Control System GN-01

Guidance Notes for Listing Class II/III/IV Medical Devices GN-02g

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 In Vitro Diagnostic (IVD) Medical D i

GN-06DevicesGuidance Notes for Listing of Importers of Medical Devices GN-07

Guidance Notes for Listing of Local Manufacturers GN-08gGuidance Notes for Listing of Distributors GN-09


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Issued DocumentsIssued 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


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Relevant InformationRelevant InformationDescription Reference Document

Scope of the MDACS GN-01 Section 3 2 1Scope of the MDACS GN-01 Section 3.2.1Classification Rules of Medical Devices TR-003 Section 7

Classification Rules of In Vitro Diagnostic Medical Devices

TR-006 Section 9

Designation of LRP GN-01 Section 3 1(b) 4 3 4 6Designation 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 01COP-01

Application for the listing of Class II/III/IV medical devices

GN-01 Section 5; GN-02

Application for the listing of Class D IVD medical devices

GN-06


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Relevant InformationRelevant InformationRelevant InformationRelevant InformationDescription Reference

Definitions of family, series and system of medical devices

GN-02 Section Item C002

Requirements on adverse incident GN 03Requirements on adverse incident reporting

GN-03

Essential Principles of Safety and P f f M di l D i

TR-004Performance of Medical DevicesLabeling requirements GN-01 Section 4.4.13/ COP-01

Section 3.12, and TR-005Conformity Assessment Framework (CAB Recognition Scheme)

GN-04, TR-001 and TR-002

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

Application for the Listing of Local GN-08, COP-03


Manufacturer MDCO (All rights reserved)

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Local Responsible PersonsLocal Responsible Persons(LRP)(LRP)( )( )


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Importance of LRPImportance of LRPpp

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

f t i t d tmanufacturer, importer and government To ensure the safe and efficacious use of the

medical devicesmedical devices To provide quality services to the users

MDACS requires that the applications for Listing of medical devices are made by LRPsy


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Who can be an LRP? A company incorporated in Hong Kong; or

A legal or natural person with business A legal or natural person with business registration in Hong Kong;

and who isand who is Itself the manufacturer or Supported by the manufacturer (the Supported by the manufacturer (the

manufacturer must designate the LRP in writing)


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Sample Letter for Designating a LRPSample Letter for Designating a LRP(GN(GN--01 Appendix 5)01 Appendix 5)

of GN-01(GN(GN 01 Appendix 5)01 Appendix 5)


20

Relationship between Manufacturer and LRPRelationship between Manufacturer and LRPApplication for listing of medical devices:Local Manufacturer can “designate” LRPs or becomes LRP byLocal Manufacturer can designate LRPs or becomes LRP by itselfOverseas manufacturers must “designate” LRPs

Overseas Manufacturer

designate

Local Manufacturer

LRP

HKSARHKSAR

LRP

Figure 1 Figure 2


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LRP for Listed Medical DevicesLRP for Listed Medical Devices

Listed Medical

LRP is responsible for th li t d di l

Submit Application

Medical Devices

the listed medical devices

( id ll i dDesignated as LRP

(provide all required document and samples)


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Responsibilities of LRPResponsibilities of LRPpp•Efficient communication channels

•Reporting changes

Communications Hub

•Reporting changes

•Making records available for inspection

•Maintain distribution records

•Managing reportable adverse incidents in Hong Kong

Safe and Efficacious

•Product alerts, modifications and recalls

•Tracking of specific medical devices

Q lit f•Maintenance and services arrangements

•Complaint handlingQuality of Services

•Complaint handling


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Obligations of LRPObligations of LRPggEffective communication

M ki d il bl fchannels (Communicate with the users,importers, public and thegovernment and to manage pre

Making records available for inspection

(E.g. the originals or certified copies of records and documents)government and to manage pre-

market and post-market matters)copies of records and documents)

Obligations ofObligations ofObligations of Obligations of LRPLRP

Distribution records (Maintain an updated list of importers and distribution records

Other obligationsOther obligations(Notify the MDCO of any changes to the information

of devices imported) submitted)


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Importers of Medical DevicesImporters of Medical Devices


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Importer of Medical DevicesImporter of Medical Devicespp

Importer means:Importer means:

A legal or natural person who brings or entrust A legal or natural person who brings or entrustothers to bring medical devices that fall withinthe scope of MDACS into Hong Kong fordi t ib ti i H Kdistribution or use in Hong Kong

But does not include any person who isut does ot c ude a y pe so o semployed or engaged by such person to carrysuch products into Hong Kong


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Importer of Medical DevicesImporter of Medical Devicespp

Li t d d iLi t d d iListed devicesListed devices NonNon--listed deviceslisted devices

“Listing of Importer”“Listing of Importer”(voluntary system)

Documents required for application for listing of importer:

(i) Body corporate/ partnership: proof of body ImporterImporter corporate or partnership (e.g., Business

Registration Certificate)Individual: Identification document

(ii) C f d t d d(ii) Copy of documented procedures


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Obligations of Listed ImportersObligations of Listed Importersgg

Establishment of Procedures

(Distribution records, handlingcomplaints advisory notices and

Making Distribution Records and relevant documents available for inspectioncomplaints, advisory notices, and

reportable adverse incidents)available for inspection

Obligations ofObligations ofObligations of Obligations of Listed ImportersListed Importers

Requirements in Respect of Advertisement, Promotional Materials etc.

Other obligationsOther obligations(E.g. Notifying the MDCO of any changes to the y ginformation submitted)


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End of SessionEnd of Session


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Classification of In Vitro DiagnosticClassification of In Vitro DiagnosticClassification of In Vitro Diagnostic Classification of In Vitro Diagnostic Medical Devices (IVDMD) Medical Devices (IVDMD) ( )( )


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Classification of IVDMDClassification of IVDMDClassification of 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 pIVDMD Classification

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


classification rules apply to the deviceMDCO (All rights reserved)

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Classification of IVDMDClassification of IVDMDClassification of IVDMDClassification of IVDMDDefinition of IVDMD Definition of IVDMD A device, whether used alone or in A device, whether used alone or in

combinationcombination intended by the manufacturerintended by the manufacturer forforcombination, combination, intended by the manufacturer intended by the manufacturer for for in vitro examination of specimens derived in vitro examination of specimens derived from the human bodyfrom the human body solely or principally tosolely or principally tofrom the human body from the human body solely or principally to solely or principally to provide information for diagnostic, monitoring provide information for diagnostic, monitoring or compatibility purposes or compatibility purposes

This is includes reagents, calibrators, control This is includes reagents, calibrators, control materials, specimen receptacles, software, materials, specimen receptacles, software,

d l t d i t t t thd l t d i t t t thand related instruments or apparatus or other and related instruments or apparatus or other articlesarticles


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Classification of IVDMDClassification of IVDMDClassification of IVDMDClassification of IVDMD

Cl I di id l P bli h lthClass Individual risk

Public health risk

D High High

C High Medium

B Medium Low

A Low Low


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Rule 1 Rule 1 --> > Class DClass D To detect the presence of, or exposure to, a

transmissible agent in blood blood componentstransmissible agent in blood, blood components, blood derivatives, cells, tissues or organs in order to assess their suitability for transfusion ororder to assess their suitability for transfusion or transplantation, orTo detect the presence of or exposure to a To detect the presence of, or exposure to, a transmissible agent that causes a life-threatening often incurable disease with a highthreatening, often incurable, disease with a high risk of propagation

E T t t d t t i f ti b HIV HCV HTLV E.g. Tests to detect infection by HIV, HCV, HTLV


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Rule 2Rule 2 To be used for blood grouping or tissue typing to

ensure the immunological compatibility of blood, blood g p y ,components, cells, tissues or organs that are intended for transfusion or transplantation are Class C (e.g. HLA)HLA), except for ABO system [A(ABO1), B(ABO2), AB(ABO3)] Rhesus System [RH1(D) RH2(C) RH3(E)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), [ ( ) ( )] y y [ ( y )FY2(Fyb)] determination which are Class D.


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Rule 3Rule 3IVD MDs are Class C if they are intended for use in:1 detecting the presence of or exposure to a1. detecting the presence of, or exposure to, a

sexually transmitted agent.E l S ll t itt d di h Examples: Sexually transmitted diseases, such as Chlamydia trachomatis, Neisseria gonorrhoeae.

detecting the presence in cerebrospinal fluid or2. detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagationlimited propagation.

Examples: Neisseria meningitidis or Cryptococcus neoformansneoformans.


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Rule 3 (continued)Rule 3 (continued)( )( )3. genetic testing.

Examples: Huntington’s Disease Cystic Fibrosis Examples: Huntington s Disease, Cystic Fibrosis.4. screening for congenital disorders in fetus

E l S i Bifid D S d Examples: Spina Bifida or Down Syndrome.5. pre-natal screening of women in order to

determine their immune status towards transmissible agents.

Examples: Immune status tests for Rubella or Toxoplasmosis.


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Rule 3 (continued)Rule 3 (continued)( )( )6. In the management of patients suffering from a

life-threatening infectious diseaselife threatening infectious disease. Examples: HCV viral load, HIV Viral Load and HIV and

HCV geno- and subtypingHCV geno and subtyping7. ……………8. ……………9. ……………10. ……………


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Rule 4Rule 4IVD MDs intended for: self-testing are Class C self testing are Class C except those devices from which the result is not

determining a medically critical status or is preliminarydetermining a medically critical status, or is preliminary and requires follow-up with the appropriate laboratory test in which case they are Class B. (E.g. Pregnancy y ( g g yself test, fertility testing)

blood gases and blood glucose determinations for near-g gpatient testing would be Class C.


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Rule 5Rule 5The following IVD MDs are Class A:

I t t i t d d ifi ll t b Instruments intended specifically to be used for IVD procedures

Specimen receptacles (E.g. plain urine cup) Reagents or other articles which possess Reagents or other articles which possess

specific characteristics intended by the manufacturer to make them suitable for inmanufacturer to make them suitable for in IVD procedures related to a specific examination (E g wash solutions)examination. (E.g. wash solutions)


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Rule 6: IVD MDs not covered in Rules 1 through 5 are Class Bthrough 5 are Class B. Examples: Blood gases, H. pylori and

physiological markers such as hormonesphysiological markers such as hormones, vitamins, enzymes, metabolic markers, specific IgE assays and celiac disease markersIgE assays and celiac disease markers.

Rule 7: IVD MDs that are controls without a tit ti lit ti i d lquantitative or qualitative assigned value

are Class B.


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How to prepare an applicationHow to prepare an applicationHow to prepare an application How to prepare an application


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Application form for the listing of IVDMD Application form for the listing of IVDMD


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MDCO (All rights reserved) Rev. 2016-05-16


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B2 - LRP Designation Letter

B4 - LRP Documented Procedures

C4 - Licencing Requirements

C5 - Batch Verification C6 - CAB Conformity Assessment Certificate

C8 – Performance Evaluation C7 – Risk Analysis

D1 - Marketing Approvals and


Essential Principles


Documents in Submission FolderDocuments in Submission FolderDocuments in Submission FolderDocuments in Submission FolderEncl. Information

Manufacturer A1 A copy of business registration certificate if theManufacturer 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 managementA2 A copy of certificate of quality management system

Local Responsible P

B1 A copy of business registration certificatePersons B2 A copy of LRP designation letter issued by the

manufacturer B3 A copy of certificate of quality managementB3 A copy of certificate of quality management

system (if applicable) B4 Copies of documented procedures established

In Vitro Diagnostic Medical Devices

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

C2 History of recalls, reportable adverse incidents,


y , p ,banning or post-market surveillance studies


Documents in Submission FolderDocuments in Submission FolderEncl. Information

In Vitro Diagnostic Medical Devices

C3 Instructions for Uses, labels and Special Listing Information

C4 Licensing requirements (if applicable)C4 Licensing requirements (if applicable) C5 Batch verification (for Class D IVDMD only) (if

applicable) C6 Conformity Assessment Certificate issued by CAB

recognized by MDCO (if applicable) C7 Risk analysis report/summary or test y p y

report/certificate C8 Performance evaluation report


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Documents in Submission FolderDocuments in Submission FolderEncl. Information

Marketing Approvals

D1 Marketing approvals obtained from Australia (TGA), Canada (Health Canada), EU, Japan (MHLW) and/or USA (FDA), and (if applicable)- HK Essential Principles Conformity Checklist MD-CCL, OR- Essential Requirements Checklist in accordance

i h h EU IVD M di l D i Di i dwith the EU IVD Medical Device Directive and Essential Principles Declaration of Conformity


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GN-06, Appendix 3 Room 604, 6/F, CityPlaza Three, Appendix 3

Essential Principles

14 Taikoo Wan Road,Taikoo Shing, Hong Kong

Principles Declaration of

Conformity


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Thank You!Thank You!Thank You!Thank You!

(The content of this presentation serves as(The content of this presentation serves as reference only. Please refer to Department of Health for details of Medical Device Administrative Control

System.)


Rev. 2016-05-16