Good Distribution Practice for Medical Devices

The Good Distribution Practice for Medical Devices (GDPMD) specifies that a quality management system shall be established, implemented and maintained by an establishment carrying out activities in the medical devices act. It requires an establishment to demonstrate its ability to maintain the quality, safety and performance of medical while its custody. It is applicable to all parties involved in the supply-chain of medical devices covering authorized representatives of foreign manufacturers, importers and distributors of medical devices. Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation or product specification. In order to provide such assurance, companies will require more than just a set of quality manuals, it requires a comprehensive system to “give assurance”. This may include appropriate procedures, suitably trained and qualified personnel, correct processes / facilities / equipment as well as clear and timely records and documentation, to credibly demonstrate the consistency of quality assurance.