[GRAPHICAL VERSION] [ÁcÅ骩]
[²Ê^ª©] [SEARCH]
[SITE MAP] [CONTACT
US]
What's New
What's New
| |
|
Proposed Documents related to Conformity Assessment under the Medical Device Administrative Control System |
|
|
| |
The following documents relating to conformity assessment of medical devices have been published:
- Guidance Notes GN-04: Conformity Assessment Framework and Conformity Assessment Bodies
- Technical Reference TR-001: Principles of Conformity Assessment for Medical Devices
- Technical Reference TR-002: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
Please click here to go to our section Guidance Notes to download the "Guidance Notes" and Technical References.
|
|
| |
|
|
[Home] [About
Us] [What's New] [Medical
Device Administrative Control System] [Search
Database] [Recall
and Alerts] [Report Adverse
Incidents] [Events]
[Educational Materials and Publication]
[Frequently Asked Questions]
[Press Release] [Download
Forms] [Useful Sites]
[Disclaimer]
[GovHK] [Asia's world city
Hong Kong]
2005 copyright | Important
notices
Last revision date: 13 October 2006