This Guidance Document has been prepared by the Medical Device Authority (MDA) to assist the industry and healthcare professionals by providing a clear guideline on managing obsolete and discontinued medical devices.

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 (Exemption) Order 2024.

This draft is open for comments and feedback. Kindly submit your input using the attached public comment form to anissuhaila@mda.gov.my and nursyaza@mda.gov.my by 26th November 2024.

To download guidance document, please download pdf Attachment 1 (981 KB) . To download feedback form, please download Attachment 2.