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   Medical Device Regulatory Affairs Site

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Product Registration

Registration of medical devices is:

  • to ensure that the Authority is aware of the medical devices that are used or that are available in the Malaysia market;
  • to assess that the medical devices meet appropriate levels of safety, quality and performance (for higher risk medical devices); and
  • to provide a means for the Authority to enforce requirements or take necessary actions to protect public health.

How get your medical device registered in Malaysia

  • Locally made or Imported medical device must undergo Conformity Assessment before they can be aproved by Medical Device Authority.
  • The Conformiy Assessment Body is similar to the Notified Body in Europe, the differences are: If your product is already registered with the GHTF/IMDRF members country, your device need only to go for Product Verification (a simpler process).
  • If your product is not registered in one of the member country of GHTF/IMDRF your device needs to go for "Full Comformity Assessment" (harder process).
  • After your device is "Conformity Assessed", you will get a certificate from the CAB and then attached this to your dossier and submit to M.D.A. via the online system.
  • If you do not have the time and manpower to get through these hurdles, seek professional help, you can try calling one of the Regulatory Affairs Consultants who can help you to arrange all these and get your product registered with minimum hassle.