New Hong Kong Medical Device Regulations Proposed

Hong Kong’s government currently does not strictly regulate most medical devices. However, in late August 2010, Hong Kong’s Medical Device Control Office proposed a framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. The new framework draws significantly from the Global Harmonization Task Force (GHTF) and the World Health Organization (WHO). Companies dealing with medical devices in Hong Kong should begin preparations for these upcoming regulations.

Hong Kong’s proposed system will align with the GHTF for medical device definition and classification. Specifically, medical devices will be classified into Classes I, II, III, and IV based on risk levels (where Class I is the lowest risk and Class IV is the highest risk). For in-vitro diagnostic medical devices (IVDMDs), there will be Classes A, B, C, and D (where Class A is the lowest risk and Class D is the highest risk).

Before medical devices can be sold in Hong Kong’s market, they will need to be registered with Hong Kong’s Department of Health (most likely through the Medical Device Control Office). The registration process and details have not been released yet. Registration for medical devices will be carried out in phases.

Local manufacturers, importers, exporters, distributors, and “Authorized Representatives” (i.e. local representative) will need to register with Hong Kong’s Department of Health. Both Authorized Representatives (ARs) and manufacturers will have significant responsibilities for post-market control.

To aid in implementing these upcoming medical device regulations, Hong Kong plans to allow for Conformity Assessment Bodies (CABs). CABs will be regulatory bodies (usually independent of the government) that will be involved in the registration process.