The certification and registration of medical products with the CFDA in China is an extensive and time consuming process. Applications, supporting documentation, and reports must be provided and precise, time sensitive communications with the Chinese certification authorities and testing laboratories is needed for a successful approval. Coordinating the process of CFDA product registration is difficult enough as it is, but language, translation and cultural differences can present a nearly impossible task for companies outside of China.
By authorizing China Certification Corporation to register your device, your CFDA certification will be managed professionally and smoothly by international team of experts.
Our services include:
- China Certification Corporation will assess which documents are needed and prepare all of the application documents for the device(s). We will then translate the completed application and supporting documentation into the Chinese language, as required by the CFDA.
- We will advise you as to the classification of the medical device into Class I, II or III.
- We will submit the application with associated documentation to the CFDA.
- We will advise you on all of the necessary steps for preparing and conducting the product tests.
- We support preparing all of the required product and company standards and submit them to the respective Chinese authority.
- We handle product testing for you, including the payment of test fees, document exchanges, communication with the test laboratory and evaluation of the Chinese test reports.
- We organize the customs clearance of test products at Chinese customs and pay all taxes and tariffs.
- We handle all of the fees and direct communication with the Chinese authorities from our offices in Beijing and Shanghai.
- We keep you informed of the progress with regular updates.
- We obtain the Chinese CFDA certificate for your product(s).
- We work together with your after-sales agent in China or support your activities in China.
For more information regarding CFDA registration, please download our free CFDA-Brochure here.
With MPR GmbH – China Certification Corporation you benefit from our years of experience, personalized service, close contacts (with the Chinese authorities and test laboratories), and our transparent pricing structure.
If you have any questions or concerns, please do not hesitate to Email or call us: Germany: +49 69 271 3769 150, UK: +44 2071931135, US: +1 773 654 2673
For more information about the costs associated with CFDA certification, please visit the next page.