Malaysia: MDA’s Approach to Expired EC Certificates for New Registration and Re-Registration of Medical Devices

The Medical Device Authority of Malaysia (MDA) announced the use of expired EC Certificates for new registration and re-registration of medical devices under certain conditions. This new approach was made due to unpredictable timeline and issues in relation to the transition to the EU MDR and to ensure a continuous supply of medical devices in the Malaysian market.

The expired EC certificate is allowed to be used for conformity assessment by the CABs under the following condition:

1. The devices continue to comply with Directive 90/385/EEC and 93/42/EEC;
2. No significant changes in the design and intended purpose of the devices; and
3. No unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health.

By meeting these conditions and providing the necessary supporting documents, manufacturers pursue the conformity assessment process with the CABs for conducting the verification process and subsequently submit to the MDA for product registration. The supporting documents include the following:

1. A letter from the competent authority granting a derogation;
2. A confirmation letter from the notified body;
3. An audit report of the quality management system; and
4. A declaration letter acknowledging the delay in issuing a new certificate.

Detailed information regarding this announcement can be accessed here.

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