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Registration types and regulatory requirements for the Asia Pacific region
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 condition as well as regulatory requirements for a successful approval of medical devices.
The seminar will discuss the following topics:
- 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)
- 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 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 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 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 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
Goal of the training
Within the scope of regulatory affairs, you can take responsibility for the global registration of your medical devices.
Your advantages of online trainings
Our online seminars continue to offer you the opportunity to stay up to date with current topics in medical technology.
During the live presentation online you can communicate directly with our speakers. In order to enable an optimal transfer of knowledge, this online seminar is designed for approx. 4.5 hours, so that we have enough time for your comments and questions. Furthermore, a small group of participants ensures an interesting exchange of experience among each other and with the speaker.
Technical requirements:
Participation in an online training course can be done via PC, tablet or even smartphone. The only requirements are an Internet connection and a standard Internet browser. No special software is required for the participants. A headset is certainly helpful to suppress background noise. An integrated loudspeaker and a microphone ensure an interactive exchange of information between the participants during the online seminar.
Services
The participation fee includes the seminar documents in electronic form and proof of participation. In addition, there will of course be an opportunity for the participants to exchange experiences and discuss with our experts.
Costs
249 € excl. tax
Buchung
Leider ist eine Buchung für dieses Seminar nicht mehr möglich. Bitte wählen Sie einen Alternativtermin.Verfügbare Termine: