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PUBLIC COMMENT DRAFT GUIDANCE DOCUMENT REQUIREMENTS FOR APPLICATION OF CERTIFICATE OF FREE SALE (CFS), MANUFACTURING CERTIFICATE (MC) AND CERTIFICATE OF FREE SALE FOR EXPORT ONLY (CFS EO) MEDICAL DEVICES

The Medical Device Authority (MDA) has published a draft guidance document  Requirements for Application of Certificate of Free Sale (CFS), Manufacturing Certificate (MC) and Certificate of Free Sale for Export Only (CFS EO)  for public comment. This guidance document is intended to provide clarity on the regulatory requirements for CFS, MC and CFS EO application.

We would like to invite the stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 23 December 2022 to 13 January 2023.

Please submit your feedback using the attached public comment form to anissuhaila [AT] mda [DOT] gov [DOT] my before or not later than 13 January 2023.

To download guidance document, please download Attachment 1. To download feedback form, please download Attachment 2.

Thank you.
 
 
 
 
Updated: 23 December 2022

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb [AT] mda [DOT] gov [DOT] my

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