how to apply for the listing of in vitro diagnostic ... to apply for the listing of in vitro...
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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
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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
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Medical Device Administrative Control System
(MDACS)
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Voluntary system To be eventually superseded by a statutory system Goal of the MDACS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
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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)
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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
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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 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
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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
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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
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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
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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
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Local Responsible Persons(LRP)
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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
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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)
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Sample Letter for Designating a Local Responsible Person(GN-01 Appendix 5)
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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
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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)
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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)
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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
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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
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Importers of Medical Devices
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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
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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
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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
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End of Session
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Classification of In Vitro Diagnostic Medical Devices (IVDMD)
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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
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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
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Classification of IVDMD
Class Individual risk
Public health risk
D High High
C High Medium
B Medium Low
A Low Low
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Classification of IVDMD: Jargons
Transmissible Agent Transfusion, Transplantation Genetics, Genes, Fetus ST: Self Testing Near-Patient Testing Preliminary Vs Follow-up
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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
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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
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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
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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 …
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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
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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
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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
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(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!
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How to prepare an application
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Application form for the listing of
IVDMD
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Application form for the listing of
IVDMD
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Application form for the listing of
IVDMD
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Application form for the listing of
IVDMD
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Application form for the listing of
IVDMD
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Application form for the listing of
IVDMD
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Application form for the listing of
IVDMD
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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
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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)
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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)
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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
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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
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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
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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
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Manufacturer
ISO 13485:2003
(A1, C1)
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BR Certificate of LRP(B1) LRP MEDICAL SUPPLIES LIMITED
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Designation Letter
(B2)
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QMS certificate of LRP
ISO 9001
(B3)
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Special Listing Information
(C3)
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Marketing Approval –
USA FDA
(D1)
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Marketing Approval –
Canada HC
(D1)
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Marketing Approval –
Australia TGA
(D1)
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Marketing Approval –
Japan MHLW
(D1)
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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
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Marketing Approval – EU
(D1)
Sample of DoC
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Sample of Annex IV Cert
(Full Quality Assurance System)
Marketing Approval – EU
(D1)
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Sample of Design Exam Cert
Marketing Approval – EU
(D1)
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Q & A