Market Access in Australia – leveraging international approvals for TGA registrations
Did you know that more than 90% of medical device registrations in Australia are granted based on prior CE marking? And most of these registrations are done within a few weeks and sometimes in a few days. Australia is a sophisticated market with a well-established GHTF model regulatory process which relies heavily on international approvals. We take a look at the current options for market access and proposed changes to broaden the recognition to include other jurisdictions outside of Europe.
Видео Market Access in Australia – leveraging international approvals for TGA registrations канала Brandwood CKC
Видео Market Access in Australia – leveraging international approvals for TGA registrations канала Brandwood CKC
Показать
Комментарии отсутствуют
Информация о видео
Другие видео канала
Traps for the unwary on quality systems – design controls before you manufactureBiocompatibility Challenges for 2019Do I really need that clinical trial? A global approach to clinical evidenceHitting the Accelerator October 2020 WebinarTime to get serious on postmarketBuilding a Technical File - Brandwood Biomedical WebinarMedical Device Regulations Under COVID-19. What you need to know.The Case For QualityHarmonisation - Triumphs and TragediesClinical Evaluation Report Webinar June 2020Webinar (Feb 2017) Postmarket Compliance ISO 134852016 & New European Medical Device RegulationsMedical Device Software: Current Developments in the Regulatory WorldMedical Device Sponsorship Requirements for Australia and New ZealandBIOCOMPATIBILITY Webinar March 2020Top FAQs for 2020Blood, Sweat and Tears - An Update to In Vitro Diagnostics Regulatory Requirements World WideFDA and ISO stars aligning on ISO 10993Documentation Deconstructed: Understanding the Technical fileClinical Trials Down Under - Skipping regulatory approvals!Why MDSAP opens a world of opportunity.