GDPMD guideline by Medical Device Authority (MDA MOH) is published to meet regulatory requirement as per Appendix 4 Schedule 3 of Medical Device Regulation 2012.

For each type of medical device, the establishment shall establish and maintain a file containing only raw materials specifications and with complete customer complaint records.

If the product lifetime is 18 months then the records retention period must be for a minimum of two years.

The management shall review its GDPMD regulatory compliance system at planned intervals, to ensure its compliance to Malaysian medical device regulatory requirements through management review process.

The Pest control program must include an SOP, Contract Agreement with Pest Control Service provider and periodical spot checks or audits.

For storage and stock handling, the organization must maintain an updated distribution records of medical devices it deals with including the make, model, batch number, serial number, and quantity of the devices.