GDPMD Quality Management System
GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD) specifies the requirements for a quality system to be established and maintained by an establishment in carrying out activities in medical device supply chain. GDPMD requires an establishment to demonstrate its ability to maintain safety and performance of medical devices throughout the supply-chain. It will be used by both internal and external parties to determine the ability of an establishment to meet the requirements specified in the guidance document.
The certification to GDPMD is to be conducted by conformity assessment body (CAB). The design and implementation of GDPMD by an establishment is influenced by the size and structure of the establishment, the processes employed and the type of medical devices it deals with.
Certification against GDPMD 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.
In Malaysia, this has been a practice by the Health Department for an establishment in a supply chain to be certified with GDPMD whilst Singapore has made it compulsory.
For further information, please contact:
Zul Sidek
