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 specifies requirements on the application for exemption of medical device for the purpose of IRE as according to the Medical Device (Exemption) Order 2024.

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-

  1. Medical Device Act 2012 (Act 737);
  2. Medical Device Regulations 2012;
  3. Medical Device (Exemption) Order 2024.

To view the guidance document,   CLICK HERE

 

 

Updated: 13 March 2025