The Medical Device Control Office (MDCO) oversees medical device regulations in Hong Kong. The MDCO is in the process of implementing mandatory registration requirements; as such, medical device registration is currently voluntary as part of a transition.
Registration in Hong Kong is based on approval in a reference jurisdiction (Australia, Canada, EU, Japan, or the US).
Let Emergo assist you in evaluating the Hong Kong medical device regulatory framework as it applies to your device(s)
Our Global Regulatory Overview Report, developed using our global network of consultants, industry sources and regulatory contacts, provides in-depth analysis of medical markets including Hong Kong. Our coverage of the Hong Kong medical device market includes:
- Regulatory Background on the MDCO
- Product Assessment
- Authorized Representation in Hong Kong
- Pending Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap for Hong Kong
Please contact us for more information on our Regulatory Overview Report for Hong Kong.