Registration types and regulatory requirements for the Asia Pacific region
Understanding medical device requirements
Classifying medical devices
Nächster Termin05.06.2025
Start / Ende10:00 / 14:30
OrtOnline
Kostenab 249,00 €
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)
Technische Voraussetzungen
Participation in an online training course can take place via PC, tablet or even smartphone. All that is required is an internet connection and a standard internet browser. No special software is required for participants. A headset is certainly helpful to suppress background noise. An integrated loudspeaker and microphone ensure an interactive exchange between the participants during the online seminar.
Zielgruppe
Personnel in quality management
Engineers in the medical device industry
Consultants in the medical device industry
Medical Safety Officers
Medical Device Manufactuerers
Newcomers in the medical device industry
Expert and executive personnell that want to update their knowledge
Personnell in charge of regulatory affairs
Leistungen
The participation fee includes the seminar documents in electronic form and a certificate of attendance. There will of course also be an opportunity for participants to share their experiences and discuss with our experts.
Vorteile
Our online seminars continue to offer you the opportunity to find out about current topics in medical technology. During the live presentation on the Internet, you can of course communicate directly with our speakers. In order to optimise the transfer of knowledge, this online seminar is designed to last approx. 4.5 hours so that we have enough time for your comments and questions. Furthermore, a small group of participants guarantees an interesting exchange of experiences with each other and with the speaker.
Seminarziel
Within the scope of regulatory affairs, you can take responsibility for the global registration of your medical devices and basic understanding of the regulations helps you to register your devices in the APAC region.
