The Hong Kong Medical Device Division (MDD) follows GHTF grouping guidance allowing applications to cover multiple product codes depending on how their sold and imported. Grouping allows for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer. To be grouped together, the products will need to adhere to the specific rules to belong to certain categories.
The different grouping categories are as follows:
IVD Test Kit
Additionally, three general rules of grouping apply to each category:
One generic proprietary name
One product owner
One common intended purpose
Contact Asia Actual for more information about Hong Kong grouping requirements.