October 6, 2017

      Recently, there have been a string of announcements released by the Malaysian Medical Device Authority to provide clear guidelines on certain matters. Following this, the MDA has released a new Guidance Document on Conformity Assessment for Medical Device that are yet to be registered.

      This new document specifies requirements for conformity assessment of a medical devices for the purpose of medical device registration by the manufacturer or authorised representative, to demonstrate compliance with the requirements of the Act 737 and subsidiary regulations under it. This applies for conformity assessment by both verification and full assessment routes. The document also identifies the responsibilities of the Authority or Conformity Assessment Bodies (CAB) in Malaysia, to confirm that the conformity assessment elements are properly or adequately applied by the manufacturer.

        A checklist for medical device conformity assessment by CAB, which serves as a minimum to be adopted by the CAB, has been included in this new guidance document. Having a look at this checklist provides the manufacturer and local authorized representatives a guideline on what are the crucial documents that will be requested by most CABs in Malaysia for their choice of assessment route. It can be helpful to allow them adequate time to properly furnish all the basic documents asked for in the Checklist, before starting to work with a CAB to perform conformity assessment on the medical device.    

To have a look at the guidance, please visit: MDA’s Official Website