The Medical Device Authority (MDA) has issued an updated regulatory approach regarding the use of expired EC Certificates for the new registration of medical devices in Malaysia. This revision is in response to ongoing challenges associated with the transition to the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Under this temporary and conditional policy, expired EC Certificates issued under Directives 90/385/EEC, 93/42/EEC, or 98/79/EC may still be accepted for conformity assessment by verification with a registered Conformity Assessment Body (CAB), but only for new registration submissions and provided specific conditions are met.
To read more, refer to the official MDA announcement:
Updated MDA Approach for New Registration of Medical Devices with Expired EC Certificates (5 June 2025)
Effectivity
The updated policy is effective from June 5, 2025.
Key Highlights
Key Conditions for Acceptance of Expired EC Certificates
- The device continues to comply with the applicable Directive (90/385/EEC, 93/42/EEC, or 98/79/EC).
- No significant changes in the device’s design or intended use.
- The device does not pose unacceptable health or safety risks.
Supporting Documents Required
- Letter from a competent authority granting derogation from normal procedures.
- Confirmation from a Notified Body of the manufacturer’s application and agreement before certificate expiry.
- QMS audit report showing compliance with EU MDR/IVDR.
- Declaration from the Notified Body confirming delays in new certificate issuance.
- Acknowledgement letter from the Notified Body confirming receipt of conformity assessment application.
Important Notes
- This update applies only to new registration applications (not re-registration or self-declared Class B IVDs).
- It aims to provide regulatory flexibility without compromising safety.
- The MDA urges stakeholders to strictly follow the outlined requirements and monitor further updates.
Revision History
- Initial Release: 27 June 2023
- Rev 1: 22 August 2024
- Rev 2 (Current): 5 June 2025
- Updated to Circular Letter No. 1 Year 2025
- Scope limited to new registrations only
- Removed references to re-registration and Class B IVD self-declarations
- Document requirements aligned with current EU transition procedures.
Implications to Clients
Clients intending to register medical devices using expired EC Certificates must ensure strict compliance with the conditions and documentation outlined by MDA. Non-compliance may result in rejection of registration applications or delays in market access.
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