The Medical Device Authority (MDA) has published a draft of the Second Edition Guidance Document titled “Definitions of Medical Devices” for public comment. This guidance document defines accessories, components, and spare parts of medical devices, and provides examples to enhance clarity.
Read the full announcement to learn more: https://portal.mda.gov.my/index.php/announcement/1730-announcement-public-comment-first-edition-guidance-document-definitions-of-medical-devices
Purpose of the Guidance Document
- To clarify and standardize the definitions of medical devices, accessories, components, and spare parts enabling the industry to correctly identify which items must be registered and regulated.
- To update detailed definitions of Medical device, accessory, component and spare parts of medical device, expanded with notes and examples.
- To provide regulatory clarification on which items require registration (e.g., accessories) and which do not (e.g., spare parts).
- To reduce ambiguity, enhance compliance, and align industry practices with MDA’s regulatory expectations.
Read the guidance document to review the draft in detail [PDF]
Public Comment Period
4th December 2025 – 18th December 2025
Feedback should be submitted using the Public Comment Form, which can be found in the full announcement link.
Submission Instructions
- Submit completed forms to: guidancedocument@mda.gov.my
- Submission deadline: 18th December 2025
Applicable Laws and Regulations
This guidance document should be read in conjunction with the following:
- Medical Device Act 2012 (Act 737)
- Medical Device Regulations 2012
Implications to Clients
- Stakeholders are encouraged to review and provide feedback on the draft guidance document.
- This guidance document defines accessories, components, and spare parts of medical devices, and provides examples to enhance clarity.
- Improved clarity reduces the risk of non-compliance, enforcement issues, or registration delays.
- Stakeholder input will contribute to the refinement and finalization of the guidance document.
Effective Date
To be announced upon final issuance of the guidance document.
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.
