Regulatory Affairs Update: Malaysia

Malaysia: MDA’s Approach to Expired EC Certificates and Self-Declared for New Registration and Re-Registration of Class B IVD Medical Devices

The Medical Device Authority of Malaysia (MDA) has announced that expired EC Certificates under certain EU Directives (90/385/EEC, 93/42/EEC, 98/79/EC) or declarations of conformity for Class B IVD devices under Directive 98/79/EC can be used for conformity assessment by registered conformity assessment bodies (CABs). This approach addresses delays in transitioning to the EU MDR and IVDR, ensuring the continued supply of medical devices in Malaysia.

Conditions for using expired certificates include:

a. The devices continue to comply with Directive 90/385/EEC, 93/42/EEC or 98/79/EC; and

b. There are no significant changes in the design and intended purpose; and

c. The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.

Additionally, the following supporting documents must be provided for conformity assessment through the verification process:

d. A formal letter from the national competent authority that has granted a derogation from the applicable conformity assessment procedure; and/or

e. A confirmation letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement prior to the expiration of the certificate; and/or

f. An audit report as evidence that the manufacturer has put in place a quality management system in accordance with MDR and IVDR; and/or

g. A declaration letter issued by the notified body stating the delay in the issuance of a new certificate; and/or

h. A self-declaration by the manufacturer confirming that the conditions for the MDR or IVDR extension are fulfilled, stating the end date of the transition period. Such self-declaration should clearly identify the devices covered by the extension and certificates concerned. The self-declaration letter shall be supported by a confirmation letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment.

Details information can be accessed here

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

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