Application for Conformity Assessment Body Recognition
(Note: The Chinese name of the Medical Device Division will be renamed with effect from 21 January 2025 while the English name remains unchanged. All issued listing certificates shall remain valid until their expiry date. For enquiry, please contact the Medical Device Division.)
Application for Recognition (or Change of Scope of Recognition)
Application Form
Application for Recognition (or Change of Scope of Recognition) Under the Conformity Assessment Body Recognition Scheme of the MDACS (MD401) (via MDIS)
Guidance Notes
[GN-04] Guidance Notes for Conformity Assessment Framework and Conformity Assessment Bodies
Technical References
[TR-001] Principles of Conformity Assessment for Medical Devices
[TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
Code of Practice
[COP-02] Code of Practice for Conformity Assessment Bodies
For other documents related to the Medical Device Administrative Control System, please refer to the Issue Document Page.
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