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 supplychain. 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 guidace 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. It is not the intent of the GDPMD to imply uniformity in the structure of the quality systems or uniformity of documentation.

Conformance to GDPMD does not imply compliance to any written laws. It is the responsibility of the establishment to ensure that they are in compliance with all applicable law in force. In the event of any contradiction between the requirements of GDPMD and any written law, the latter shall take precedence.

 

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