Masterclass China: Medical Device Marketing Authorisation for Advanced - New regulations on medical devices, perfection of pre-market registration an - Webinar von FORUM Institut für Management GmbH

- Update your regulatory knowledge - Pre-Market Registration (PMR): Minimalise your efforts and costs - Acceptance of European registration tests - Clinical pathways: From feasibility study report (FSR) to a clinical trial - Post-market Surveillance (PMS): NMPA legal agent - Chinese Instruction for Use (IFU) and label - Change management - Facts and trendsInterested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable insights into the latest Chinese regulations governing medical devices, and discover strategies to optimize your pre-market registration and post-market surveillance. Benefit from the expertise of our local specialists, who will share up-to-date information to enhance your success

Explore advanced insights into Chinas latest regulatory changes, PMR optimization, and the post-market surveillance system in our seminar.- Stay informed with detailed updates on recent regulatory shifts, notably the 2021 medical device law and its ongoing subsidiary regulations. Our local experts will share practical examples, addressing PMS and change management. - Your questions and discussions are encouraged! Seize the interactive opportunity to converse directly with local experts during Q&A sessions. Join us for a streamlined, informative experience.

The seminar is conceptualized for specialists and managers in the medical device and IVD industry who are managing medical device marketing authorisation in China. Good knowledge of the Chinese medical device market and its legal framework is an important prerequisite. This online course is of particular interest for the following departments: - Regulatory, clinical and quality affairs - Strategy & corporate development - Product management - Distribution and salesBasic knowledge on medical device marketing authorisation in China is a prerequiste for the training.