Application for Conformity Assessment Body Recognition
Application for Conformity Assessment Body Recognition
(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.)
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 (CAB-AA)
Update Information for Listed Traders and Conformity Assessment Bodies (CAB) under Medical Device Administrative Control System (MDACS)
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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Only submissions with duly completed application forms and required documents will be processed. Materials provided with any submission will not be returned.