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

The Medical Device Authority (MDA) has updated the Guidance Document to include the definitions of accessories, components, and spare parts. This update aims to assist industry stakeholders in correctly identifying which items require registration and in ensuring compliance with relevant regulatory requirements.

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.

To view the guidance document, click here.