Certification - Medical Devices
Good Distribution Practices of Medical Devices
What is GDPMD?
GDPMD or Good Distribution Practices of Medical Devices specifies the requirements for a quality system to be established and maintained by an establishment in carrying out activities in medical device supply-chain which includes the wholesale of medical devices in Malaysia as well as the import of medical devices into Malaysia.
The GDPMD certification in required by medical device establishments operating as Authorized Representative, Distributors as well as Importers of medical devices.
Authorized Representative (AR) is the wholesaler of a medical device representing the foreign manufacturer of that device in Malaysia and holding the sole proprietorship of that device in Malaysia with the device being registered with the Medical Device Authority of Malaysia with the ownership of the device being placed under the AR.
Distributors are wholesalers appointed by the AR to distribute the medical devices registered under their ownership in Malaysia. Distributors do not hold the sole proprietary rights towards the medical device. An AR may appoint as many Distributors, however, a Distributor shall not appoint another Distributor.
Importers are those establishments importing medical devices into Malaysia.
The pre-requisite for an organization to gain an establishment license from the Medical Device Authority of Malaysia as an AR, Distributor, Importer or any combination of the three is that the organization shall be certified to GDPMD prior to application for establishment license.
- Benefits of GDPMD
- Current version of the GDPMD
Benefits of GDPMD
- 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 devices
- Improve operation efficiency through continual improvement processes
Current version of the GDPMD
The GDPMD or Good Distribution Practices of Medical Devices certification guidelines in Malaysia was established by the Malaysian Medical Device Authority (MDA) as per the requirements of Appendix 4 of the 3rd Schedule of the Medical Device Regulations 2012 with the GDPMD guidance document number MDA/RR No 1 (November 2015, First Revision) which is available in the MDA website.