The Medical Device Authority (MDA) of Malaysia has published the First Edition of the Guidance Document on Application for Confirmation Status of Obsolete and Discontinued Medical Devices.
This guidance provides clarity on the regulatory pathway for managing obsolete and discontinued medical devices in Malaysia, particularly in situations where such devices may no longer fully comply with current registration requirements.
Read the full guidance here: [PDF]
Purpose of the Guidance
- To provide structured guidance on the application process for obtaining confirmation of obsolete and discontinued medical device status.
- To clarify how such devices should be managed within the Malaysian regulatory framework.
Scope of Application
This guidance applies to manufacturers, Authorized Representatives, importers, distributors, and healthcare institutions handling medical devices classified as obsolete or discontinued in Malaysia.
Key Highlights
- Establishes the application process for confirmation of obsolete and discontinued medical device status
- Clarifies regulatory requirements under the Medical Device Act 2012 (Act 737)
- Refers to exemptions granted under the Medical Device (Exemption) Order 2024
- Outlines control measures to safeguard patient safety and ensure device performance
Implications to Clients
Clients managing obsolete or discontinued medical devices may be required to obtain formal confirmation from the Medical Device Authority (MDA) prior to continued use, importation, or supply.
Compliance with applicable exemption conditions under the Medical Device (Exemption) Order 2024 must be ensured.
Early regulatory assessment and documentation review are recommended to avoid disruptions in supply or regulatory non-compliance.
Effective Date
March 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.