China is one of the biggest markets of the healthcare industry which makes it attractive for manufacturers of in vitro diagnostic (IVD) medical devices. 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 IVD devices in China is increasingly becoming standardized and stringent. The NMPA issues regularly new and updated requirements to further optimize the regulatory oversight of IVD devices. Foreign manufacturers must comply with the challenging requirements to enter the Chinese market and be prepared for a dynamically improving regulatory environment. The costs and time frame of an NMPA certification varies depending on the classification and type of the IVD device. For the IVD devices in Class I (comparable to Class A products according to Regulation (EU) 2017/746 (IVDR)), the notification is relatively streamlined, while the registration process for IVD devices of Class II/III (comparable to Class C/D of the IVDR) can be very time-consuming and expensive if regulatory authorities require for example clinical trials conducted with Chinese population.
NSF PROSYSTEM provides you with an overview of the registration process highlighting the key points that must be considered for obtaining a notification or registration certificate. We guide you through the NMPA registration so that you can meet the legal and normative requirements on the Chinese market. Moreover, 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 the quality management system, post-market surveillance, labelling, responsibilities and liabilities as a market approval holder or legal representatives in China.
The seminar covers the following topics
Current status of regulatory requirements in China
Classification and registration of IVD devices
Registration type and approval process of IVD devices and required by national testing laboratories
Clinical evidence expected by the NMPA
QMS audit and post market surveillance in China
Labeling requirements (UDI, UDI Registration, Chinese Name etc.)
Responsibilities of the legal representative, electronic submission, infringements and penalty
Zielgruppe
Manufacturers of IVD medical devices
Regulatory affairs managers
Quality management specialists
Medical device engineers
Leistungen
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.
Seminarziel
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.
