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Hong Kong Medical Device Grouping
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
- IVD Cluster
A family is a group of medical devices having the same manufacturer, device description and classification, intended use, design, construction and performance e.g. catheters of different diameters and lengths. For each member of the medical device family, its identifier(s) (e.g. product number), and a brief account of its characteristics that distinguish it from other members (e.g. dimensions of its various parts) are to be provided.
A system is a medical device comprising a number of medical devices (component medical devices) intended to be used together to fulfil the system’s intended use. All component medical devices shall be placed on the market under the name of the same manufacturer. A short description on how the component medical devices are used together to achieve the intended purpose of the medical device system shall be provided. For each component medical device of a medical device system, please provide its Asian Medical Device Nomenclature System (AMDNS) term (if an AMDNS term is not available for a particular component, a short description shall be provided) and the corresponding AMDNS code, its identifier(s) (e.g. model number), and a brief description of its intended use.
A series is a group of medical devices belonging to the same model series of a manufacturer and having the same device classification and intended use, but differing only in minor features or functions that do not present significantly different safety, performance, and effectiveness issues. In principle, the designs, labeling, and manufacturing processes and performance specifications cannot be significantly different between members of a series. For each member of the medical device series, its identifier(s) (e.g. product number), and a brief account of its characteristics that distinguish it from other members (e.g. dimensions of its various parts) are to be provided.
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.
Hong Kong Regulatory Support
Latest Market Updates
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