GDPMD CERTIFICATION

GDPMD System Implementation
Stage 1 Audit - Documentation Review
Stage 2 Audit - Site Audit
Certification of GDPMD System
Establishment License Registration with Medical Device Authority
Overview

Regulatory requirements for medical device safety & performance. It shall be implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian Medical Device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737).

Benefit
  • Helps organizations in saving 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 distribution.
Recognition

Medical Device Authority, Ministry of Health Malaysia

Others

Certification 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 laws in Malaysia.