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