Malaysia: The Acceptance of Expired CE Certificate for the New or Re-registration of Medical Devices

Referring to EU Directives 90/385/EEC and 93/42/EEC, the Medical Device Authority (MDA) recognizes the EC Certificate as an approval type for the conformity assessment procedure by way of a verification process for medical device registration in Malaysia.

Legally, a valid certificate must be attached to the new medical device registration or re-registration submission. Due to the EU MDR transition with unforeseen timelines and issues, MDA has taken an approach to accepting the expired EC Certificate for the conformity assessment procedure through a verification process by registered conformity assessment bodies (CABs) if the following conditions are met:

• The device continuously complies with Directive 90/385/EEC and 93/4/EEC

• no significant changes to the design and intended purpose

• no unacceptable risk of health or safety presented to the patients, users, or other persons, or other aspects related to the protection of public health

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

• National competent authority formal letter granting a waiver from the conformity assessment procedure

• Confirmation letter from notified body certifying the manufacturer’s application receipt for conformity assessment and conclusion of a written agreement before the expiration of the EC Certificate

• Evidence with an audit report to prove the quality management system in accordance with MDR

• Declaration letter by notified body stating the delay in issuance of a new certificate

Source: Medical Device Authority (MDA)