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 the transition. Only medium- and high-risk devices are eligible for voluntary listing at this time.
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 Regulatory Pathway service, developed using our global network of consultants, industry sources, and regulatory contacts, provides in-depth analysis of medical device markets, including Hong Kong. Our coverage of the Hong Kong medical device market includes:
- Regulatory Background on the MDCO
- Product Assessment and Classification
- In-Country Representation in Hong Kong
- Voluntary Medical Device Registration Requirements
- Labeling and Language Requirements
- Costs and Timeframes
- Regulatory Roadmap for Hong Kong
- Post-Market Obligations