MDACS Activities

MDACS Activities

Medical Device Administrative Control System uses Asian Medical Device Nomenclature System (AMDNS)

19 Jun 2009

With immediate effect, the Asian Medical Device Nomenclature System (AMDNS) will be used in the Medical Device Administrative Control System for product descriptions and identifications. The AMDNS designed specifically for regulatory applications is derived from the Universal Medical Device Nomenclature System (UMDNS) and could be obtained from our website. The device codes and terms of these two systems are fully compatible and interchangeable. All new applications for listing medical devices under the Medical Device Administrative Control System shall use the new Form MD-C2&3&4 with the AMDNS/UMDNS Codes and Terms filled in Note C004. The old forms MD-C2&3 and MD-C4 will also be accepted until 30 September 2009 if the AMDNS/UMDNS Codes and Terms are provided.

Back