Asia-Pacific Requirements

Beschreibung

Asia-Pacific Requirements

The English-speaking seminar “Registration types and regulatory requirements for the Asia Pacific region” qualifies you for the medical device approval process in the Asia Pacific markets. It provides you the framework as well as regulatory requirements for a successful approval of medical devices.

The seminar covers the following topics:

• Registration of medical devices in China: regulatory framework of China, Classification of Medical Devices according to NMPA and Registration Unit, Registration Type, Approval Process of Medical Devices, QMS Requirements and Post-Market Surveillance
• Registration of medical devices in ASEAN countries (Malaysia, Singapore, Philippines, Thailand): Responsible Authorities, ASEAN Medical Device Directive (AMDD), ASEAN Common Submission Dossier Template (CSDT), Singapore’s regulatory framework
• Registration of medical devices in Taiwan: Taiwan Food and Drug Administration (TFDA), Medical Device Act(2021-05-01), Regulations for Governing Issuance of Medical Device License, Listing and Annual Declaration, Post-market Surveillance in Taiwan
• Registration of medical devices in Japan: Pharmaceutical and Medical Device Act (PMD Act), Ministry of Health, Labor and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), Medical Device Single Audit Program (MDSAP) requirements
• Registration of medical devices in Korea: Ministry of Food and Drug Safety (MFDS, formerly known as KFDA), Medical Device Act (MDA), Korean Good Manufacturing Practice (KGMP)

• Registration of medical devices in Australia: Therapeutic Goods Administration (TGA), Medical Device Single Audit Program (MDSAP) requirements, Australian Regulatory Guidelines for Medical Devices (ARGMD), Australian Register of Therapeutic Goods (ARTG)