In addition to a sustained economic and population growth and an ageing population, the Chinese healthcare market has achieved an average annual growth rate of over 10%. The Chinese market is becoming increasingly important for most international manufacturers. However, market entry in China is not easy due to the dynamically developing regulatory requirements. The NMPA (National Medical Products Administration) is responsible for the administration and monitoring of medicines, medical devices and cosmetics. All medical devices imported into China are subject to NMPA approval.
Registration of Your Medical Devices in the Chinese Market
Registration in China is one of the most demanding processes for foreign manufacturers. The NMPA has high expectations of foreign manufacturers and re-quires an enormous administrative effort for product approval. There are Chinese guidelines, standards and requirements. The cost and time frame of the NMPA certification varies according to the classification of the medical products. For Class I medical devices, the registration process is relatively streamlined, while the registration process for Class II/III medical devices can be very time-consuming and expensive, e.g. when clinical studies are required in China. Our multilingual experts can assist you with the registration of medical devices in China, from regulatory analysis, strategy development, type testing, preparation or review of submission documents, clinical evaluation, NMPA submission, post-market compliance and NMPA inspection.
Technical Documentation for Submission in China
The content and requirements of the submission dossier depend on the classification of the medical devices and the type of product. The NMPA continuously establishes specific approval guidelines for certain medical devices, which should be considered when preparing the submission dossier. Our experts, who are native speakers, can assist you in preparing or reviewing your submission dossier based on the relevant regulatory requirements for your products.
Clinical Evaluation for Approval in China
The requirements for clinical verification in China are very high. For most Class II and Class III devices (including IVD reagents), a clinical evaluation report that complies with NMPA guidelines is an essential document in the approval dossier. If the clinical evidence is considered insufficient, a clinical investigation should be conducted that is costly and time-consuming. Our experts have in-depth expertise in clinical evaluation for the NMPA and can help you provide enough clinical evidence for the NMPA.
Inspections by the Chinese Authority
At the end of 2018, the NMPA adopted the final guidelines for the inspection of overseas medical device manufacturers. The NMPA aims to shift the focus of medical device management from strict regulatory approval to strict post-market surveillance. The entire life cycle of imported medical devices is regulated by the NMPA. Soon, you may also be confronted with the NMPA inspection, which is conducted in Chinese. With our native speakers and our experience in various inspections, we can help you to pass NMPA inspections in a targeted manner.
Training: Successful Medical Device Approval in China
If you are interested in the Chinese market and would like to get a first impression of the regulatory requirements, or if you would like to get an overview of medical device registration in China, you are cordially invited to participate in our 1-day training course „Successful Approval of Medical Devices in China“ in Hamburg.
View our upcoming training courses.
With our experience and expertise in the regulatory requirements for medical devices and IVDs in China, we can support you with your product approval in China.
For further details on product approval in China or for a non-binding offer, please contact us.