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    Successful approval for medical devices in China

    China is one of the biggest markets of healthcare industry and is 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, NSF 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.

    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.

    Your advantages of online trainings

    Our online seminars continue to offer you the opportunity to keep up to date with current topics in medical technology, despite travel restrictions.
    During the live presentation online you can communicate directly with our speakers. In order to enable an optimal transfer of knowledge, this online seminar is designed for approx. 4.5 hours, so that we have enough time for your comments and questions. Furthermore, a small group of participants ensures an interesting exchange of experience among each other and with the speaker.

    Technical requirements:

    Participation in an online training course can be done via PC, tablet or even smartphone. The only requirements are an Internet connection and a standard Internet browser. No special software is required for the participants. A headset is certainly helpful to suppress background noise. An integrated loudspeaker and a microphone ensure an interactive exchange of information between the participants during the online seminar.

    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.

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