GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by an establishment of medical device importer/distributor/ authorized representative to comply with Malaysian Medical Device Act 2012 (Act 737) and Medical Device Regulations 2012. The objective of GDPMD is to ensure the quality, safety and performance of medical device which include but not limited to product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration and after sales service; tracking, documentation and record-keeping practices.
Benefits of GDPMD
GDPMD drives best practice and helps organizations:
- Savings in 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.
