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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.

Benefits of GDPMDS

  • Savings in cost from reduction of defects and rejects
  • Meet regulatory requirements and customer expectations
  • Consistency to proper storage, handling, distribution and traceability
  • Demonstrate ability to produce safer and more effective medical devices
  • Improve operation efficiency through continual improvement processes