The China NMPA registration process could be challenging, and can take from a few months to several years, depending on the product. The costs and the exact timeframe of the registration process varies, among all, on its classification and the testing required. REQUEST A NONCOMMITTAL QUOTATION. Medical devices are divided into Class I, II, and III. This system is similar to that in the EU or US and is based on potential risk levels; however, especially in class II there could be variances.
The process of China NMPA registration is complex. Even experienced companies could encounter unforeseen challenges. Our committed consultants can guide you through China's regulatory processes, from identifying product classifications and preparing the application documents in Chinese to approval and issue of the NMPA certificate. Cisema specializes in bypassing clinical trials in China. If clinical trials are mandated, Cisema can define the clinical trial criteria for your product, identify and coordinate with accredited laboratories, and ensure compliance with all regulations. The NMPA approval for medical devices is valid for 5 years. Learn more about the process of China NMPA registration including timeline and how Cisema avoids clinical trials in our brochures.
The NMPA Legal Agent for Medical Devices has a wide range of responsibilities. The agent is not only responsible for the registration, supervision of the tests conducted and administrative component during the registration application, but also bears the joint responsibility for product quality and after-sales business together with the manufacturer. In our service offer for medical device NMPA Legal Agent you will find more information.
Manufacturers intend on appointing a Chinese distributor as NMPA Legal Agent should be aware of the underlying risks involved. Unfortunately, if your distributor is uncooperating at points of your partnership and declines to relinquish the original NMPA certificates and "Technical Requirements" to you, you are in a position of dependency that prevents you from changing distributors, requesting a change or renewal of your NMPA registration and, consequently, importing your products. The only solution in most cases is to change NMPA Legal Agent. If you have problems with your NMPA Legal Agent, we are here to help. What else you should consider when choosing the NMPA Legal Agent, you can learn in our brochures.