Gain market access in Hong Kong with conformity assessment

Medical Device Administrative Control System (MDACS) registration

Medical Device Administrative Control System (MDACS) registration

Hong Kong currently has no mandatory registration for medical devices, but manufacturers and importers can opt for voluntary registration under the Medical Device Administrative Control System (MDACS).

For products voluntarily listed in the MDACS, conformity assessment during both design and manufacturing is now a requirement. Manufacturers can demonstrate their compliance with an audit conducted by a Conformity Assessment Body (CAB), such as BSI who are recognized by the Medical Device Control Office (MDCO).

Hong Kong’s regulatory system and conformity assessment procedure

Although Hong Kong (HK) is part of China, it has a different regulatory system and imports the majority of its medical products. The Department of Health in Hong Kong set up a Medical Device Administrative Control System (MDACS) based on the International Medical Device Regulators principles. The government intends to make the MDACS a mandatory system in the near future. Under the Conformity Assessment Body (CAB) recognition scheme, the Medical Device Control Office (MDCO) will only recognize CABs such as BSI, that meet all the necessary requirements.

Understanding HK’s regulatory system is key to helping you break into this very profitable market. The purpose of the MDACS is to:

  • Raise public awareness of the safe use of medical devices
  • Enable manufacturers and other interested parties to familiarize themselves with regulations
  • Promote acceptance of current voluntary recommendations and future mandatory requirements for medical devices of all risk classes

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