Malaysia MDA, Regulatory approach on the use of expired EC Certificate for new medical device registration
On June 5, 2025, the medical device Authority (MDA) of Malaysia announced a revised regulatory approach regarding the use of expired EC certificates for the purpose of new medical device registration in Malaysia.
CE Marking (EC Certificate) issued under EU Directives 90/385/EEC, 93/42/EEC, and 98/79/EC continues to be recognized by the MDA as a valid form of approval for conformity assessment in the Malaysian medical device registration process. The conformity assessment shall be carried out through the verification process with a registered Conformity Assessment Body (CAB).
Generally, certificates and Declaration of Conformity (DoC) must be valid at the time of submission. However, in light of the ongoing transition to EU MDR and IVDR, a temporary and conditional approach has been adopted as follows:
Expired EC Certificates may be accepted for conformity assessment via a registered CAB if the following conditions are met
- The medical device continues to comply with the relevant requirements of EU Directives 90/385/EEC, 93/42/EEC, and 98/79/EC
- There are no significant changes in the design or intended purpose of the device
- The device does not present an unacceptable risk to the health or safety of patients, users, other persons, or to public health.
At the time of application for conformity assessment verification, one or more of the following supporting documents must be submitted
- An official letter issued by the competent authority of the relevant country
- A confirmation letter from the Notified Body (NB) verifying that the manufacturer submitted a conformity assessment application and that a written agreement was concluded prior to certificate expiry
- An audit report demonstrating that the manufacturer has implemented a Quality Management System (QMS) in compliance with the EU MDR or IVDR requirements
- A declaration letter from the NB confirming a delay in the issuance of a new certificate
- A confirmation letter form the NB acknowledging receipt of the application for conformity assessment.
Please refer to the attachment document below.
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