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Successful approval for medical devices in China

China is one of the biggest markets of healthcare industry and is really attractive for global medical device manufacturers. However, the market access and the Chinese registration for foreign manufacturers is a challenging topic. 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 steadily becoming standardized and stringent. NMPA issues constantly new requirements in Chinese and foreign manufacturers must comply with the challenging requirements to enter the Chinese market. The cost and time frame of NMPA certification vary according to the classification of the medical devices. For the medical devices in Class I, the notification usually takes up to one year for the manufacturers to complete, while the registration process for medical devices in Class III can be very time-consuming and expensive if clinical trials are necessary in China. Furthermore, we inform you about the mandatory registration test in China for Class II/III medical devices, test centers in China and the test process.

In order to help our clients successfully and smoothly obtain a notification/registration certificate, PROSYSTEM provides you an overview and key points of the registration process in China. We lead you through the NMPA registration and help you to meet legal and normative requirements for the Chinese approval. Moreover, the Clinical Evaluation becomes more and more crucial in the Chinese registration and an insufficient and unstructured Clinical Evaluation Report (CER) could affect the success of your registration. In this seminar, we help you to initiate a compliant CER for NMPA or help you to transform your existing European CER into NMPA compliant CER format.

Besides the seminar, PROSYSTEM also offers various services focusing on Chinese Regulatory Affairs such as a premarket gap analysis specifically for your product, NMPA clinical evaluation report and other technical documentation.

Content of the training:

  • Status quo of medical device industry in China
  • Regulatory requirements in China
  • Type testing and industry standards in China
  • Classification according to new CFDA Guideline
  • Detailed CFDA registration process for medical devices
  • Clinical Evaluation Report for CFDA
  • Market Inspection of CFDA
  • Labeling
  • Infringements & Consequences
Target group
  • 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 devices, including registration tests, classification, clinical evaluation report and necessity for clinical trials. The seminar content will be deepened through practical examples and discussions.

Services

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.

Price

590 € excl. tax

Booking

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