Successful approval for medical devices in China
China is one of the biggest markets of healthcare industry which makes it attractive for global medical device manufacturers. However, both the market access and the registration process in China are challenging for the foreign manufacturers.
The NMPA (National Medical Products Administration, former CFDA) is responsible for the registration of all imported drugs, medical devices and cosmetics in China.
The management and supervision for medical devices in China is increasingly becoming standardized and stringent. NMPA issues regularly new and updated requirements to further optimize the regulatory oversight of medical devices. Foreign manufacturers must comply with the challenging requirements to enter the Chinese market and be prepared for a dynamically improving regulatory environment. The cost and time frame of NMPA certification vary according to the classification and type of the medical devices. For the medical devices in Class I, the notification is relative streamlined for the manufacturers to complete, while the registration process for medical devices in Class II/III can be very time-consuming and expensive if clinical trials are necessary in China.
NSF PROSYSTEM provides you with an overview of the registration process highlighting the key points you must consider for obtaining a notification/registration certificate. We guide you through the NMPA registration and help you to meet legal and normative requirements for placing your product on the Chinese market. Moreover, the clinical data become more and more crucial for the registration. An insufficient and unstructured clinical evaluation report (CER) could derail your registration. This seminar will show you how to prepare the NMPA compliant CER. Since NMPA puts more focus on the post-market supervision of the medical devices, the seminar will also explain the requirements on QMS and post-market surveillance, labelling, responsibilities and liabilities as a market approval holder or legal representatives in China.
Furthermore, we inform you about the promising fast-track registration processes such as registering innovative medical devices, priority registration and conditional registration. Since the registration test according to the Chinese standards are essential for the registration, you will also learn the challenges of these tests.
Content of the training
- Status quo of medical device industry in China
- Introduction to the medical device Regulation and responsible Authorities in China
- Classification of medical device according to NMPA and Registration Partition
- Registration Type and Approval Process of medical device
- Clinical Evidence for NMPA
- QMS Requirement, Inspection and Post Market Surveillance in China
- Labeling Requirements (UDI, UDI Registration, Chinese Name etc.)
- Responsibilities of the China Representative, electronic Submission, Infringements & Penalty
- Medical Device Manufacturers
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Engineers in the medical device industry
Goal of the training
The seminar will give the participants an overview about the NMPA registration process. Participants will learn the essential regulatory requirements for NMPA approval of medical device, including registration tests, classification, clinical evaluation, necessity for clinical trials, PMS surveillance and possible on-site inspection from NMPA. The seminar content will be deepened through practical examples and discussions.
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.