Seeking to clarify requirements manufacturers must follow when grouping medical devices together for the purpose of product registration, the Malaysian Medical Device Authority (MDA) in February released a new draft guidance document describing the applicable rules and procedures.
According to the draft guidance, products appropriate to be registered as a group are generally sold under one proprietary name, produced by one manufacturer, and have a common intended purpose. They can be systems, families, or sets.
Systems consist of a medical device made up of several individual components designed to work together. Families are a collection of medical devices with a common intended purpose. Sets are collections of two or more medical devices with a common use, assembled together as one package by a manufacturer.
In addition, products with different proprietary names or brand names may be submitted for approval together in one product registration application if they meet certain criteria.
The new guidance is available on the MDA website.