This webinar is designed to provide guidance on the US FDA medical device regulation with emphasis on premarket submission processes such as premarket notification [PMN or 510(k)], De Novo Classification Request, and Premarket Approval (PMA). Other aspects of US FDA medical device regulatory controls including device classification, establishment registration and listing, QS Regulation/GMP, and post-market requirements will be covered.
• US FDA organization and medical device regulation
• Premarket requirements and submission types
• Quality system regulation/Good Manufacturing Practice
• Post market controls
• Steps to get FDA medical device clearance/approval
Mr Albert Li is the Director of the Office of Medical Device Evaluation, Center for Measurement Standards (CMS), Industrial Technology Research Institute (ITRI), Taiwan. He is responsible for CMS/ITRI’s US FDA FDAMA 510(k) Accredited Person (Nov 1998-Nov 2020), FDA Reauthorization Act (FDARA) 2017 3P510k Review Organization (Since Nov 2020) and US FDA MDUFMA Quality System Regulation Inspection Accredited Person (Since Oct 2003). He also leads CMS/ITRI’s TFDA/MOHW Medical Device QMS/GDP Authorized Auditing Organization (Since 2003) and TFDA/MOHW Class II IVD Technical Review Organization (Since 2004). Mr. Li is an active member of AHWP/TC, AAMI, and CLSI and he joins ISO TC210 WG1, ISO TC 299 WG2/WG6 as observer.
This webinar is sponsored by AMMI and open to all participants from AMMI, Asia Pacific Medical Technology Association (APACMed), Malaysia-Taiwan Economic Cooperation Committee Business Advisory Group (MTECC BAG) members which include Federation of Malaysian Manufacturers (FMM), SME Association of Malaysia, Malaysian Organisation of Pharmaceutical Industries (MOPI), Taipei Investors' Association in Malaysia (TIAM), etc.
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