“Regulatory Requirements for Medical Devices in China” is the second webinar of a two-part webinar series held together with SPECTARIS GmbH. The first webinar mainly deals with the strategic planning of the approval, while the second webinar focuses on regulatory practice.
The second webinar is primarily aimed at RA and QM experts. The regulatory requirements are the focus here: Essential topics such as regulatory principles, the classification of medical devices, UDI, standards and information on the correct registration of medical devices are considered in detail here. Participants from the RA area should receive a detailed and up-to-date insight into the regulatory innovations and challenges.
Click here for detailed information about the two-part webinar series.
Date and Time
September 30, 9:00am -12:30pm (Germany time)
Program Content
- Overview of the approval process for medical devices
- Competent authority(ies)
- Regulatory bases (laws, directives, standards & guidance)
- Classification of medical devices
- Registration and filing of documents
- Duration of the procedure and validity of the approval
- Application of standards/guidelines
- Necessary on-site tests
- Cooperation with registration agents
- Chinese UDI system
- Chinese cybersecurity/privacy requirements
Speaker
- Mr. Stefan Fischer – Managing Director of the Cisema Group
- Mr. Guo Ning – General Manager of Cisema Beijing
- Ms. Anna King – Business Consultant and Country Manager
Language
The webinar will be conducted in German.
Our Services
The process of China NMPA registration is complex, and can take from a few months to several years, depending on the product. The costs and the exact timeframe of the registration process varies, among all, on its classification and the testing required.
Even experienced companies could encounter unforeseen challenges. Our committed consultants can guide you through China’s regulatory processes, from identifying product classifications and preparing the application documents in Chinese to approval and issue of the NMPA certificate.
Cisema specializes in bypassing clinical trials in China. If clinical trials are mandated, Cisema can define the clinical trial criteria for your product, identify and coordinate with accredited laboratories, and ensure compliance with all regulations. The NMPA approval for medical devices is valid for 5 years. Learn more about the process of China NMPA registration including timeline and how Cisema avoids clinical trials in our brochures or contact Cisema directly.
