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Good Distribution Practice for Medical Devices (SS620)

The Good Distribution Practice for Medical Devices (GDPMDS) is a mandatory audit for any organizations involved with importing, wholesale and distribution of medical devices prior to their license application. This comes under the purview of the Health Science Authority of Singapore. A Certification of GDPMDS means that medical devices are properly stored, transported and handled under suitable condition as required by the product specification.

With a view to provide such assurance, organizations will need to include in their Site Master File the appropriate procedures, employ suitably qualified personnel, correct processes / facilities / equipment as well as clear and timely documentation, to credibly demonstrate the consistency of quality assurance for the medical devices.