Medical Device Authority (MDA) wishes to inform all industry players and healthcare providers that an updated guidance document has been issued. The update involves the revision of the requirement related to foreign manufacturers as follows:

4.8e)   Foreign manufacturer: Shall provide the name, address and contact details [email and/or phone number and/or website address], is optional) for technical assistance.

All stakeholders are advised to refer to the latest version of the guidance document for detailed information. 

To access the guidance document, please CLICK HERE.

For further inquiries, please contact:


Guidance document unit

Policy and Strategic Planning Division (DASAR) MDA.

  • Mr. Mohd Naquib : +603-8230 0209
  • Ms. Anis Suhaila: +603-8230 0236
  • Ms. Nur Syaza: +603-8230 0362
  • Email: guidance [email protected]

 

Prepared by : Policy and Strategic Planning Division (DASAR) MDA.

Uploaded by: Corporate Communication Division