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Medical Device Administrative Control System

imgGuidance Notes

(Note: The Medical Device Control Office has been renamed as the Medical Device Division with effect from 1 October 2019. Please refer to Contact Us page for updates in contact information and contact our office for enquiry, if necessary.)

Guidance documents for the Medical Device Administrative Control System
are available in pdf format:

[GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System PDF
 
[GN-01] Overview of the Medical Device Administrative Control System
PDF
 
[GN-01S] Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System PDF
 
[GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices (Jul 2011 Edition) PDF
 
[GN-03] Guidance Notes for Adverse Incident Reporting by Local Responsible Persons PDF
 
[GN-04] Conformity Assessment Framework and Conformity Assessment Bodies PDF
 
[GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (Jan 2019 Edition) PDF
 
[GN-07] Guidance Notes for Listing of Importers of Medical Devices (Apr 2018 Edition) PDF
 
[GN-08] Guidance Notes for Listing of Local Manufacturers PDF
 
[GN-09] Guidance Notes for Listing of Distributors PDF

imgTechnical References

[TR-001] Principles of Conformity Assessment for Medical Devices PDF
 
[TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) PDF
 
[TR-003] Classification Rules for Medical Devices PDF
 
[TR-004] Essential Principles of Safety and Performance of Medical Devices PDF
 
[TR-005] Additional Medical Device Labelling Requirements PDF
 
[TR-006] Principles of In Vitro Diagnostic (IVD) Medical Devices Classification PDF

imgCode of Practice

[COP-01] Code of Practice for Local Responsible Persons PDF
 
[COP-02] Code of Practice for Conformity Assessment Bodies PDF
 
[COP-03] Code of Practice for Listed Local Manufacturers PDF
 
[COP-04] Code of Practice for Listed Importers of Medical Devices (Apr 2018 Edition) PDF

imgOthers

[RS-01] List of Recognised Standards for Medical Devices PDF
 

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Last Revision Date: 4 November 2020