Home About Qualtech NEWS MALAYSIA: New Guidance Document for Requirements for Application of Certificate of Free Sale (CFS) For Export Only Medical Devices - December 2018
MALAYSIA: New Guidance Document for Requirements for Application of Certificate of Free Sale (CFS) For Export Only Medical Devices - December 2018

December 11, 2018

MDA has recently released a new guidance document regarding the requirements for application of Certificate of Free Sale (CFS) for export only medical devices. There had been plenty of queries received by MDA on the application of CFS for various applications and as a first step, they have released this GD, specifically for export only medical devices.

  1. Prior to applying for this CFS, it is the applicant’s responsibility to confirm if their device is indeed a medical device.
  2. After that, it has been specified that the applicant who require CFS shall submit the completed ‘CFS application for export only medical device exempted from registration form’ together with relevant documents by email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
  3. This GD also outlines the Requirements for CFS application for export only medical device exempted from registration such as the general medical device information, quality management system (QMS) certificate information, etc. It is to be noted that to apply for CFS for export only medical devices, certain components of CSDT are still required to be submitted and the necessary details are described in this GD.

Upon satisfactory review of all documents provided as required in the GD and subject to payment of the fees as specified, MDA will issue an approval for issuance of CFS.

The application fee to obtain a CFS for export only medical devices is RM 250.00. Upon approval of the application, the CFS certificate fee is as following. Additional certificates may be issued upon request subject to payment of applicable CFS certificate fees.

MY Article 3 1

Example of calculation:

MY Article 3 2

 

Reference:

Guidance Document for Requirements for Application of Certificate of Free Sale (CFS) For Export Only Medical Devices

 
Home About Qualtech NEWS MALAYSIA: New Guidance Document for Requirements for Application of Certificate of Free Sale (CFS) For Export Only Medical Devices - December 2018