By Stewart Eisenhart, Emergo Group
The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used these Notified Bodies for certification.
The following eight Notified Bodies were identified in the new TGA announcement:
- TÜV Rheinland InterCert Műszaki Felügyeleti és Tanúúsító Korlátolt Felelősségű Társaság and SGS Hungária Minoségellenorzo, Kereskedelmi és Szolgáltató Kft. based in Hungary
- EVPU a.s. and 3EC International a.s. in Slovakia
- Institut Pro Testováni A Certificaci, a.s. (ITC) in the Czech Republic
- Three Notified Bodies based in Turkey: Alberk QA Uluslararası Teknik Kontrol ve Belgelendirme Anonim Şirketi, Kalitest Belgelendirme ve Egitim Hizmetleri Ltd Sti. and Szutest Teknik Kontrol ve Belgelendirme Hizmetleri Ticaret Limited Şirketi.
The British Medical Journal previously named the eight firms in a 2012 article that raised questions about consistency among European Notified Bodies in conducting conformity assessment audits and certifications; the Notified Bodies listed above may have performed audit and certification duties without ample rigor, according to the journal.
TGA authorities are implementing additional application audit requirements in order to verify whether applicants whose certifications were made by the eight listed Notified Bodies have properly established quality management systems, and that these applicants’ devices do indeed comply with essential principles necessary for Australian market registration.
“This is an extremely interesting development,” observes Evangeline Loh, Ph.D., Vice President of Global Regulatory Affairs at Emergo. “It looks like TGA is formalizing to some extent what we had expected, and may be the first regulatory authority to formally and publically act on the British Medical Journal article.”
Several device categories are targeted for 510(k) exemption by the guidance, including anesthesiology, cardiovascular, dental and ophthalmic devices. A full list of qualifying devices is available in the guidance document.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.