GDPMD is aimed to demonstrate organization's ability to maintain quality and innovation of medical devices in compliance with the Malaysian medical device regulatory requirement.

The GDPMD certification is to be conducted by the non- registered conformity assessment body (CAB).

Quality is defined as meeting customer and regulatory requirement and the device is safe and performs as per its intended purpose.

GDPMD guideline by Medical Device Authority (MDA MOH) is published to meet regulatory requirement as per Appendix 4 Schedule 3 of Medical Device Regulation 2012.

Detailed description on how the relevant and applicable regulatory requirements are addressed for each medical device specified in the scope of the GDPMD regulatory compliance system must be documented in the Laboratory Compliance Manual.

For each type of medical device, the establishment shall establish and maintain a file containing only raw materials specifications and with complete customer complaint records.