Verfügbare Termine:
Registration of IVD devices in China
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 medical devices and IVD products in China is increasingly becoming standardized and stringent. The NMPA issues regularly new and updated requirements to further optimize the regulatory oversight of IVD 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 costs and time frame of an NMPA certification varies depending to the classification and type of the medical devices. For the IVD products in Class I (comparable to Class A products according to Regulation (EU) 2017/746), the notification is relatively streamlined for the manufacturers, while the registration process for medical devices in Class II/III (comparable to Class D products according to Regulation (EU) 2017/746) can be very time-consuming and expensive if regulatory authorities require that clinical trials have to be conducted with Chinese population.
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.
Content of the training:
- 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/li>
Target Group
- Manufacturers of IVD medical devices
- Regulatory affairs managers
- Quality management specialists
- Medical device engineers
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.
Services
The participation fee includes the seminar documents in electronic form and proof of participation. In addition, there will of course be an opportunity for the participants to exchange experiences and discuss with our experts.
Costs
590 € excl. tax
Buchung
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