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 cfs@mdb.gov.my.
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.

No	Validity	Fee (RM)
1	2 years	100
2	5 years	300
Calculation is based per number of country requested. Certificate is inclusive of 1 attachment. Additional pages will be charged RM5.00 per page. Each attachment will list up to 25 medical devices. Certificate will be issued based on per country.

Example of calculation:

No	Application	Calculation
1	1 Country 100 medical devices 1 copy of certificate Validity 2 years	25 medical devices per attachment thus require 4 attachments. (RM 5 x 4 attachment = RM20); RM 250 (application fee) + RM 100 (2 years validity)                               + RM20 (Attachment) = RM 370
2	1 Country 100 medical devices 2 copies of certificate Validity 2 years	25 medical devices per attachment thus require 4 attachments. (RM 5 x 4 attachment = RM20); RM 250 (application fee) + RM 100 (2 years validity) + RM20 (Attachment) = RM 370 for 1 CFS For 2 copies: RM 250 (application fee) + (RM 120 x 2) = RM 490
3	2 Countries 1 medical device 1 copies of certificate Validity 5 years	RM 250 (application fee) + [RM 300 (Validity 5 years) x 1 (Attachment) x 1 (copy) x 2 (countries)] = RM 850

Reference:

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