Medical Device Authority (MDA) has published a draft guidance document ‘IMPORTATION OF MEDICAL DEVICE FOR PERSONAL USE’ for public comment. This guidance document is intended to inform the public on the guidelines to bring into (import) medical device to Malaysia.

We would like to invite the public to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 31 July 2023 to 14 August 2023. Please submit your feedback using the attached public comment form to [email protected] before 14 August 2023.

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

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 (Duties and Obligations of Establishments) Regulations 2019; and

d) Medical Device (Advertising) Regulations 2019.

To view the guidance document, CLICK HERE

 

 

Updated: 1st of August 2023