Medical Device Administrative Control System
Issued Documents
Guidance Notes for the Medical Device Administrative Control System
Guidance documents for the Medical Device Administrative Control System
are available in pdf format:
Overview of the Medical Device Administrative Control System (GN-01)
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 of Importers of Medical Devices (GN-07)
Guidance Notes for Listing of Local Manufacturers (GN-08)
Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System
Technical References
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)
Code of Practice
Code of Practice for Local Responsible Persons (COP-01)
Code of Practice for Conformity Assessment Bodies (COP-02)
Code of Practice for Listed Local Manufacturers (COP-03)
Public Consultation on Regulation of Medical Devices
(July to September 2003)
Consultation Document
Pamphlet for the Consultation
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2005
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Important notices
Last revision date: 12 June 2008
| Important notices
