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The Conformity Assessment Body Recognition Scheme was launched on 13 October 2006 as phase III of the Medical Device Administrative Control System (MDACS). Under this scheme the Medical Device Control Office will recognize qualified organizations to become Conformity Assessment Bodies (CABs) to carry out independent assessment of medical devices intended to be listed under the MDACS. We are now accepting applications from interested parties to become CABs. If you are interested in becoming a CAB, please refer to the following documents:
- 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 above Guidance Notes and Technical References. |