Confomity Assessment

Declaration of Conformity is one of the regulatory requirements imposed in the Medical Device Regulation 2012. It is an attestation drawn up by the manufacturer that its medical device fully conforms to all applicable Essential Principles of Safety and Performance (EPSP) of medical device and other requirements of Act 737 and the regulations under it.

Conformity assessment
The systematic examination of evidence generated and procedures undertaken by the manufacturer, under requirements established by the Authority, to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Principles of Safety and
Performance for Medical Devices (EPSP).

The manufacturer shall be required to attest that its medical device complies fully with all essential principles for safety and performance and shall draw up a declaration of conformity in the format as specified in Appendix 3 of the Schedule.

AQCTA shall review and confirm the adequacy of the declaration of conformity by examining the supporting documents or other evidence. DoC reviewed by AQCTA shall be uploaded in MeDC@St (web-based Online Application System).

Overview

The conformity verification is done by way of verifying the evidence of conformity of medical device that has been approved in prior by the foreign regulatory authority or notified body recognized by MDA.

Section 7 of the Medical Device Act 2012 (Act 737) requires the carrying out of conformity assessment by the conformity assessment body registered within section 10 of Act 737. This is a precondition for having a medical device registered under the Act.

Notwithstanding above, AQCTA may require additional document or information, as it thinks fit, to complete the review.

Full conformity assessment process is applicable to medical devices and IVD medical devices which are not approved in prior by recognized foreign regulatory authorities or notified bodies listed in MDA recognized foreign regulatory authorities or notified bodies and the respective approval types eligible for conformity assessment by way of verification.