(GDPMD) applies to all companies carrying out activities, as stated in the Medical Devices Act 2012 (Act 737). Malaysian Medical Devices Act 2012 (Act 737) requires all the medical devices manufactures, exporters, importers, distributors, and local authorized representatives to be certified to a Medical Device Quality Management System or Good Distribution Practices for Medical Devices (GDPMD) and register their products as part of the Medical Devices, effectively enforced on 1st July 2013

Section 10 of Medical Device Act ( Act 737 ) requires a medical device to undergo conformity assessment by a registered CAB prior to its registration. However, many medical devices have undergone conformity assessment and approved in countries recognized by Medical Device Authority (MDA).

ISO 13485 is an Internationally Recognized Quality Standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices.