Medical Device Authority (MDA) has published a guidance document ‘MEDICAL DEVICE FOR THE PURPOSE OF EXPORT ONLY” for public comment.

This guidance document specifies requirements on the application for an exemption of medical devices for the purpose of export only as according to the Medical Device (Exemption) Order 2024. A “Medical Device for Export Only Exemption Letter” letter is issued by the Authority then permits the medical device to be exported.

We would like to invite the industry and stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 28 April to 7 Mei 2025. Please submit your feedback using the attached public comment form to anissuhaila@mda.gov.my  or nursyaza@mda.gov.my my before 7 Mei 2025.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following:

a) Medical Device Act 2012 (Act 737);

b) Medical Device Regulations 2012;

c) Medical Device (Exemption) Order 2024

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

 

Last Updated on 28th of April 2025