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GDPMD Consulting

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 that companies dealing with medical devices have a quality distribution system in place. This ensures that the quality of the medical devices is maintained throughout the storage and distribution processes. The certification towards GDPMD is a mandatory requirement in the application of an Autrorized Representative’s, Importer’s or Distributor’s Licence.

The aim of GDPMD is to ensure the quality, safety and performance of medical devices, which include, but not limited to, product sourcing and procurement, storage, transportation and delivery, installation, testing and commissioning, service and maintenance, calibration, after sales service; tracking and record-keeping practices.

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

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Kazami Consultancy 

Kazami Consultancy provides full consultancy services and guidance on GDPMD certification from scratch, from development of procedures and forms, guidance on the documentation and guidance in implementation, until the GDPMD certificate is obtained. By engaging us, the process to get GDPMD certification will be a lot more faster and hassle-free as we have the expertise to build up the GDPMD system for you !

GDPMD Drives Best Practice and Helps Organizations To:

Savings in cost, from reduction of defects and rejects

Meet regulatory requirements and customer expectations.

Consistency towards proper storage, handling, distribution and traceability.

Demonstrate ability to produce safer and more effective medical device

GDPMD Regulatory Compliance System Element:

Part 1


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

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