This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.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


This draft document is open for comment and feedback. Please submit your feedback form to anissuhaila@mda.gov.my before 24 June 2022.To download guidance document, please download  Attachment 1. To download feedback form, please download  Attachment 2.

 

Updated: 8th June 2022