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

Product Conformity Assessment by way of verification 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 with pre-market approved by the recognised countries.

  • Helps organization that manufacturing or distribute the medical devices to register their products with the Malaysian Medical Device Authority.
  • Specifically for medical devices with the recognised pre-market approval.

Medical Device Authority, Ministry of Health Malaysia


Pre-market approvals that has recognition by Medical Device Authority, Malaysia, means the medical devices are adopting conformity assessment and approval of medical devices placed in the market of certain countries.