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 serves as guidance for local manufacturers and authorized representatives to apply for conformity assessment by way of verification (abridged) process to CAB for initial and re-certification assessment and to submit medical device registration submissions via the Medical Device Centralised Online System (MeDC@St) for 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