Good Distribution Practice for Medical Device in Malaysia

GDPMD Services

What is GDPMD?

GDPMD stands for Good Distribution Practice for Medical Device. It specifies the requirements for a quality management system (QMS) which has to be designed, established, implemented and maintained by companies carrying out activities in the medical device supply-chain. Authorised Representatives, importers and distributors of medical devices in Malaysia must implement GDPMD and obtain an establishment licence from the Medical Device Authority (MDA) to comply with the Medical Device Act (Act 737) and the Medical Device Regulations 2012.

What is GDPMD For ?

A GDPMD system is intended for ensuring medical devices are properly handled, stored and transported so that the safety and efficacy of the devices are not compromised whilst transiting through the supply chain. A key principle of GDPMD is that the establishment takes responsibility for the medical devices by ensuring that they have appropriate personnel, facilities, transport and procedures in place. GDPMD also caters for device traceability in case of issues or recalls through the proper keeping of distribution records.

Certification Process for GDPMD and MDA Establishment License

The certification of GDPMD is conducted by registered Conformity Assessment Bodies (CAB) and is regulated by MDA. With a valid GDPMD certification, you can then apply for an establishment licence from MDA for your company.

Understand the GDPMD regulatory requirements
Develop and implement standard operating procedures and forms which are compliant with GDPMD
Conduct an internal audit to ensure the GDPMD QMS is being followed
Have your GDPMD QMS audited by a Conformity Assessment Body (CAB)
Obtain your GDPMD certificate
Apply for the MDA Establishment Licence for LAR, Importer/Distributor

How We can Help

We provide you with training and a tailored, practical GDPMD quality management system; after its implementation, we conduct an internal audit and support you through the certification audit by a Conformity Assessment Body (CAB). At Cubic Life Sciences, we have a team of experienced professionals who possess the necessary expert knowledge to guide and assist you. Appointing the right consultant is key to your success with a GDPMD QMS. Get in touch!

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