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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
Target Group
  • 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
Training Goal

Within the scope of regulatory affairs, you can take responsibility for the global registration of your medical devices.

Services

The participation fee includes the seminar documents, meals and the participation certificate. Of course, there will also be an opportunity to exchange experiences with the participants and to discuss with our experts.

Preis

990 € excl. tax

Buchung

Leider ist eine Buchung für dieses Seminar nicht mehr möglich. Bitte wählen Sie einen Alternativtermin.

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