Why Need Medical Devices Conformity Assessment?

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).

MDA Circular Letter No 2/2014 sets the policy relating to conformity assessment for medical devices approved by countries recognized by MDA. The policy simplifies the process of conformity assessment and accelerate medical device registration under Act 737.

All medical devices manufactured, imported or distributed in Malaysia shall be subjected to conformity assessment as stipulated as per above requirements.

Medical devices which have not been obtained with any approvals by regulatory authorities or notified bodies listed in Table 1 are required to undergo full conformity assessment by any registered CAB in accordance with the requirements as stipulated in Section 7(1)(a) of Act 737.