PRODUCT CONFORMITY

Completion of technical documentation
Conformity assessment of QMS, PMS, Technical Documentation & Declaration of Conformity
Establishment License Verification
Certification of Full Conformity Assessment
Overview

Full conformity assessment is a solution designed to ensure that medical devices meet the specific requirements set by a regulatory authority in the importing country.

Applicable to medical devices without pre-market approved by the recognised countries.

Benefit
  • Helps organization that manufacturing or distribute the medical devices to register their products with the Malaysian Medical Device Authority.
  • Specifically for medical devices without the recognised pre-market approval.
Recognition

Medical Device Authority, Ministry of Health Malaysia

Others

Conformity assessment becomes more stringent as the risk of medical device increases.