Conformity Assessment for Medical Devices in Hong Kong

The Medical Device Control Office (MDCO), part of Hong Kong’s Department of Health, recently made official the Conformity Assessment Framework. This is a framework for new conformity assessment requirements for medical devices and information on Conformity Assessment Bodies (CABs).

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). The government intends to make the MDACS a mandatory system in the future. Demonstrating compliance to accepted standards of safety and efficacy can also help a product’s marketability in Hong Kong.

For products voluntarily listed in the MDACS, conformity assessment during both design and manufacturing is now a requirement. Manufacturers can demonstrate their compliance with a conformity assessment audit conducted by a CAB, a third-party assessor recognized by the MDCO. They can also meet the requirement by providing current, valid marketing approvals for a founding member of the Global Harmonization Task Force (mainly Australia, Canada, the EU, Japan, and the US).

Conformity Assessment, in the new system, includes information on technical features of products , quality management system, and post -market surveillance system. The details differ depending on the device’s classification. The MDCO uses a four-class system, ranging from Class I (lowest risk) to Class IV (highest risk). More specific details are described in the document Overview of the Medical Device Administrative Control System, available at the MDCO website.

The MDCO has publicized the requirements for becoming a CAB, including the application form, in the document Conformity Assessment Framework and Conformity Assessment Bodies. The MDCO hopes that the Conformity Assessment Framework can help ensure a higher level of protection of public health and safety and maintain public confidence in medical products.