Veranstaltungen Terminkalender Februar 2019
Registration types and regulatory requirements for the Asia Pacific region
5. - 6. Februar 2019 , Der genaue Veranstaltungsort wird noch bekannt gegeben
The English-speaking seminar “Registration types and regulatory requirements for the Asia Pacific region“ qualifies you to speed up approvals on the Asia pacific markets. It provides you the framework condition as well as regulatory requirements for a successful approval.
- Registration of medical devices in Australia: Therapeutic Goods Administration (TGA), MDSAP requirements, Australian regulatory guidelines for medical devices (ARGMD), Australian Register of Therapeutic Goods (ARTG)
- Registration of medical devices in Korea: MDFS (KFDA), Medical Device Act Law No.6909, KGMP
- Registration of medical devices in Japan: Pharmaceutical Affairs Law (also known as PAL), PMD Act legal framework is the responsibility of Japan’s Ministry of Health, Labour and Welfare (MHLW). Pharmaceuticals and Medical Devices Agency (PMDA)
- Registration of medical devices in Taiwan: Taiwan Food and Drug Administration (TFDA) and the Department of Health (DOH).
- Registration of medical devices in Malaysia: (Medical Device Act, MDA) and (Medical Device Authority Act, MDAA)
- Registration of medical devices in Singapore: Health Science Authority (HAS); Medical Device Information and Communication System (MEDICS)
- Registration of medical devices in China: legal framework of the CFDA, Classification of Medical Devices according to CFDA and Registration Partition, Registration Type and Approval Process of Medical Devices
- Medical Device Manufacturers
- Regulatory Affairs
- Newcomers in the medical device industry
- Expert and executive personnel that want to update their knowledge
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Engineers in the medical device industry
- Consultants in the medical device industry
- Medical Safety Officer‘s
Within the scope of regulatory affairs, you can take responsibility for the global registration of your medical devices.