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 was prepared as a guidance for Conformity Assessment Bodies (CAB) to conduct conformity assessment process by way of verification for initial and recertification assessment for the purpose of medical device registration in Malaysia.

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. Circular Letter No. 1/2025 Conformity Assessment Procedures for Medical Device Approved by Recognised Countries.

To view the guidance document,  CLICK HERE