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Good Distribution Practice for Medical Devices (GDPMDS)
Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors, Importers and local Authorized Representative require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment Licence
Certification against GDPMDS qualifies that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification.
In an effort to provide such assurance, organizations will require more than a few quality manuals. Organization needs to include appropriate procedures, suitably qualified personnel, correct processes / facilities / equipment as well as clear and timely documentation, to credibly demonstrate the consistency of quality assurance.