In light of ongoing challenges related to the EU’s regulatory transition, the Medical Device Authority (MDA) Malaysia has updated its stance on the use of expired EC Certificates for new medical device registrations. This update, outlined in MDA Circular Letter No. 1 Year 2025, aims to maintain access to medical devices while aligning with international regulatory shifts.
Here’s a breakdown of what manufacturers and stakeholders need to know.
What’s Changing?
The MDA will temporarily and conditionally accept expired EC Certificates, originally issued under Directives 90/385/EEC, 93/42/EEC, and 98/79/EC, for new registration submissions in Malaysia, as long as specific criteria are met.
This update comes in response to the delays and unpredictability associated with the full implementation of the EU MDR and IVDR.
Eligibility Conditions for Using Expired EC Certificates
Expired EC Certificates may be accepted under the following strict conditions:
- The device continues to comply with the provisions of its original directive.
- There are no significant changes in the design or intended purpose.
- The device poses no unacceptable risk to health or safety.
Required Supporting Documents (At Least One of the Following):
To proceed with verification through a registered Conformity Assessment Body (CAB), the applicant must provide one or more of the documents below:
|
Supporting
Document
|
Description
|
|
National
Competent Authority Letter
|
Confirms a
derogation from conformity assessment procedure.
|
|
Notified
Body Confirmation Letter
|
Acknowledges
receipt of conformity assessment application and agreement prior to certificate expiry.
|
|
QMS Audit
Report
|
Demonstrates
compliance with EU MDR/IVDR QMS requirements.
|
|
Notified
Body Declaration Letter
|
Explains
delays in issuing new certificates.
|
|
Application
Receipt Acknowledgement
|
Confirms the
notified body has received the conformity assessment application.
|
Key Scope Limitations (as of 5 June 2025, Revision 2):
- Applies only to new registration submissions.
- No longer applicable to re-registration and Class B IVD self-declarations.
- Requirements have been streamlined in line with current EU transition procedures.
MDA continues to provide regulatory flexibility where appropriate, without compromising patient safety. Industry players are advised to closely follow this updated framework and prepare supporting documentation accordingly.
Published by MDA on 5 June 2025
