Medical Device Authority (MDA) has published a guidance document ‘IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE” for public comment.

This document serves as guidance for individuals who intend to bring any unregistered medical devices into Malaysia for the purpose of personal use. The applicant may request a confirmation letter regarding the status of the personal use me

We would like to invite the industry and stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 22 January to 3 February 2025. Please submit your feedback using the attached public comment form to anissuhaila@mda.gov.my  or nursyaza@mda.gov.my my before 3 February 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.

 

Updated: 22 January 2025

By: Corporate Communication Unit