EMERGO BY UL SUMMARY OF KEY POINTS: The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market. TGA will continue recognizing conformity assessments from UK-based Notified Bodies for existing and new ARTG listings and applications. Short-term effects of a potential orderly or no-deal Brexit should be minimized by TGA measures as described.

Emergo关键点摘要： 澳大利亚卫生部（DoH） 从2019年开始每年三次发布植体产品清单。 在澳大利亚的私人保险公司以及植体器械制造商及其经销商都将受到影响

EMERGO SUMMARY OF KEY POINTS: Australian Department of Health (DoH) to publish Prostheses List three times per year starting in 2019 Private insurers as well as prosthetic device manufacturers and active in Australia as well as their distributors will be impacted

Emergo重点摘要： 新的澳大利亚TGA指导性文件为先进和新颖的医疗器械和IVD制定了优先审查指定路径。 符合条件的医疗器械必须达到与严重疾病或病症、未满足的临床需求和突破性技术等相关的标准。 TGA作出优先审核指定申请批复决定所需时间将不超过20个工作日。

EMERGO KEY POINTS: New Australian TGA guidance establishes a priority review designation pathway for cutting-edge and novel medical devices and IVDs. Qualifying devices must meet criteria pertaining to serious diseases or conditions, unmet clinical needs and breakthrough technologies. TGA decisions on priority review designation applications will take no more than 20 business days.

ZUSAMMENFASSUNG DER WESENTLICHEN PUNKTE DURCH EMERGO: Die Pilotphase des gemeinsamen Medizinprodukte-Audit-Programms (Medical Device Single Audit Program, MDSAP) wurde beendet und das Programm wurde vollständig im Januar 2017 in den USA, Kanada, Brasilien, Australien und Japan umgesetzt. In Australien zeigten jedoch nur größere Medizinprodukte-Unternehmen Interesse am MDSAP. Kleinere Hersteller müssen erst von den Vorteilen des MDSAP überzeugt werden.

EMERGO SUMMARY OF KEY POINTS: The Medical Device Single Audit Program (MDSAP) ended its pilot phase and became fully implemented in January 2017 in the United States, Canada, Brazil, Australia and Japan. In Australia, only larger medical device manufacturers have shown interest in MDSAP so far. Smaller Australian manufacturers have yet to be sold on MDSAP’s benefits.

Die australische Therapeutic Goods Administration (TGA) plant Audits von Zulassungsanträgen (Link auf Englisch) für Medizinprodukte,...

Update September 16, 2014: TGA has corrected its list of Notified Bodies whose certifications will undergo application audits in Australia. The list of affected Notified Bodies has been adjusted for accuracy below.

Die australische Therapeutic Goods Administration (TGA) erlaubt Herstellern von registrierten Teilimplantaten für Knie, Hüften und...