Medical Devices and IVDs

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 partnershup 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.

  • Are you a medical device manufacturer and want to sell your medical device once or multiple times to customers in China?
  • You may already be shipping your medical device to China, but recently your product's classification has changed?
  • Do you want to know how much time and money you have to factor in for the China NMPA registration of your medical device?
  • Do you have questions regarding quality management system regulations in China?
  • Does your distributor also act as your NMPA Legal Agent and no longer cooperates?
  • Do you know how many tests and test samples will have to be provided?
  • Are you concerned that a clinical trial will be required before your medical device can be sold?
  • Do you have any concerns about revealing the exact manufacturing method and composition of your medical device during the registration process?
  • Does your medical device qualify for prioritized registration procedure?

Which services can Cisema support you with?

Cisema can provide a full range of services to companies seeking NMPA approval, ensuring the most appropriate route to NMPA approval in China for your product:

One-stop service offer for medical device and IVD registration in China

  • Complimentary full-cost calculation including timeline for NMPA registration
  • Classification (risk class I, II or III) of medical devices and IVDs
  • Clinical pathway strategy
  • Templates and document checklists for application
  • Writing of product technical requirement (PTR)
  • Test sample import and logistics
  • Coordination of type tests
  • Translation of documents into Chinese
  • Chinese label drafting according to NMPA requirements
  • Clinical Evaluation Report (CER) composition
  • NMPA application dossier compilation
  • Responding to supplementary notice and meetings with NMPA reviewers
  • Collection and handover of NMPA certificate
  • NMPA Legal Agent service for registration and post market surveillance (PMS)
  • Clinical Research Organization (CRO) services
  • Advice on applicable legislation and relevant regulations
  • Post-approval support, e.g. changes, extensions, and renewals of product registrations

Cisema highly recommends companies begin engaging with us from the start of the application process as we believe that gross errors can be avoided. Even correctable mistakes will lead to significant delays and increase in monetary investment.

Find out how we can help you expand your market reach to China. To obtain further relevant information, we recommend our exclusive brochures.

We are at your disposal

Contact

Do not hesitate to contact us if you have further questions or to request a non-binding offer.
You can contact us at +1 (0)773-449 5169 (US & Americas) or + 49 (0)89-4161 7389-00 (EU and worldwide) or via email.

To obtain further relevant information we recommend you
to visit our knowledge area or our registration page for exclusive information brochures.

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