fbpx

GDPMD (Good Distribution Practices for Medical Devices)

What is GDPMD?

Good Distribution Practices for Medical Devices (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 aim 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.

Companies that are involved in wholesaling and/or importing Medical Devices in Malaysia are required to implement a quality management system and obtain GDPMD certificate to applying for licence for their establishment.

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 device

GDPMD Regulatory Compliance System Element:

  • Part 1 : Preliminary
  • Part 2 : Organization & GDPMD Regulatory Compliance System
  • Part 3 : Establishment Responsibilities
  • Part 4 : Resource Management
  • Part 5 : Supply Chain and Device Specific
  • Part 6 : Surveillance and Vigilance

ADTAC Consultancy Services

ADTAC provide full consultancy services and guidance on MeSTI certification from scratch, development of procedures and established forms, guidance on the implementation until certificate is obtained. By engaging us, the process to get MeSTI certification will be a lot more faster and hassle free as we have the expert to build up the procedures for you !

Contact us now for more
details on our services