The transition period to implement the compliance with the new Malaysian registration procedure requirements reached its end last June 30, 2016.
Starting from July 2016 and to market the devices in Malaysia, the approval of a Conformity Assessment Body (CAB) prior the submission to the Regulatory Authority is required.
The reviewing activities executed by the CAB include the documentation analysis and the Quality System Management assessment.
After the approval by the CAB, it is possible to submit the application to the Medical Device Authority (MDA).
For further information: