Good Distribution Practice for Medical Devices (GDPMD) sets out the conditions for a quality management system to be established, implemented and maintained by an establishment of medical device importer/ distributor/ authorized representative. The objective of GDPMD is to ensure the quality, safety and performance of medical device during all aspects of medical device supply-chain until it reaches the end user of Point of Care.
Why need to apply for GDPMD
Since 1st January 2018, the Malaysian Medical Device Authority (MDA) requires all organizations involved in the medical device supply chain must apply for Establishment License Certificate (for the registered company that sells device) and Medical Device Registration Certificate (for each medical device) in order to be legally qualified to sell medical device in Malaysia.
In addition, to apply for Establishment License as an Authorized Representative, Importer and/or Distributor with MDA, the party must get certified with GDPMD by Conformity Assessment Body (CAB) recognized by MDA.
Who should apply for a GDPMD Certificate?
Various people and entities within the supply chain for medical devices as stated below shall obtain GDPMD license for their establishments:
- Authorized Representative (AR)
- AR serves as a contact point for foreign manufacturer in Malaysia and the AR is responsible to register the medical device with MDA.
- This is because foreign manufacturer is not eligible to apply for Establishment License.
2. Importer or Distributor
- Each medical device shall only have one Authorized Representative in Malaysia, but the medical device can have more than one importers and distributors in Malaysia, provided that the importers and distributors are given authority to import and/or distribute by the Authorized Representative.
The organizations applying for GDPMD certification shall be registered with the Suruhanjaya Syarikat Malaysia (SSM) before applying for GDPMD certification, Malaysia.
Benefits of GDPMD
GDPMD promotes best practices and assists organisations in the following ways:
- Saving in cost from reduction of defects and rejects.
- Meet regulatory requirements as well as customer expectations.
- Maintaining consistency in storage, handling, distribution and traceability.
- Demonstrate ability to produce safer and more effective medical devices.
Conclusion
Medical device manufacturers interested in entering the Malaysian market should be aware of the GDPMD certification process. Seek the advice of a regulatory expert if you have any further questions about GDPMD implementation for your medical device or GDPMD consultation in Malaysia.
