Medical Device Regulators show an interest in IAF based accreditation for ISO 13485
Regulatory agencies that require a valid ISO 1385 certificate to register a medical device in their country are taking a genuine interest in the new IAF Accreditation System for ISO 13485. The Therapeutic Goods Administration of Australia has now adopted the new IAF program and successfully used it to track down a phony certificate with the help of IAF member accreditation bodies.
At a recent inaugural meeting of the International Medical Device Regulators Forum (IMDRF), the IAF initiative for ISO 13485 was presented to leading regulatory authorities from China, Brazil, the United States, Canada, Europe and Russia. A representative from the World Health Organization was also in attendance. The new IAF Brochure for IAF ISO 13485 initiative was appreciated by attending medical device regulators. One of the regulators that took a copy of the brochure has since requested that the new IAF program be presented at an upcoming Asian Harmonization Working Party meeting.