BSI was the first Notified Body to officially receive approval from Hong Kong Department of Health to be a Hong Kong Conformity Assessment Body (CAB) under the Medical Device Administrative Control System (MDACS). Under the CAB Recognition Scheme, the Medical Device Control Office (MDCO) will only recognize CABs that meet all the necessary requirements including operating with the highest degree of professional integrity, competence and independence. What does that mean to you when using BSI as your Hong Kong CAB? You can expect the following benefits:
Benefits
- Current CE Mark Clients will need to submit much less documentation with quicker HK approval
- Companies will be able to get CE Mark and HK Registration together with one assessment
- Registration approval can help companies to differentiate their product from non-registered products
- Customers can gain a competitive advantage by completing the registration process now before it becomes mandatory
- Minimize the distribution of confidential technical documentation
Learn more about the Hong Kong’s Regulatory System
Two Certificates with One Assessment
The technical documentation requirement for Hong Kong is very similar to Europe. BSI as a registered Conformity Assessment Body in Hong Kong has the ability to issue two certificates (CE Marking and HK CAB approval) with only one technical assessment. This is a cost effective way for clients to get approval without go through a new registration process again and again in different countries.
Hong Kong Regulatory Forum and Newsletter
