GDPMD
Good Distribution Practice for Medical Devices.
MedicalMalaysia Specific
It applies to all companies carrying out activities, as stated in the Medical Device Act 2012 (Act 737). It specifies the requirements for a quality management system to be established and maintained by an establishment.
Key Benefits
- Mandatory for medical device establishment license (MDA).
- Ensure quality and integrity of medical devices.
- Manage recalls and complaints effectively.
- Traceability throughout the supply chain.
Who Needs This?
Importers, distributors, and authorized representatives of medical devices in Malaysia.
* Certification, training, and compliance requirements vary by government tender, buyer, regulator, corporate supply-chain requirement, and project scope. Confirm the specific requirement before applying.
Ready to get certified?
We provide full documentation and training support.