Automotive CCC

China Certification is an excellent partner for the CCC certification in the automotive sector. We are providing leading automotive suppliers and car manufacturers with quick and smart solutions for their CCC certification. We offer you our support for every project related to the Automotive CCC.

leggi di più

CCC Made Easy

The China Compulsory Certification (CCC) is a mandatory certification for products exported to China.
We are experienced in the CCC certification process for all kinds of product categories. The CCC certification process will be simple and easy with China Certification Corporation as a professional partner by your side.

leggi di più

CFDA

Cosmetic products and medical devices need a CFDA registration before they can be sold in China. We offer the evaluation of CFDA classifications (Class I – III) for the medical devices, and guide you through the complete approval processes.

leggi di più

Other Certifications

HAF604, Taiwan Certification, CRCC for Railway Products, SRRC Type Approval, NAL (Network Access License), AQSIQ registration, Voluntary CQC Mark Certification, CCCF for Fire Products: We support you in all types of certifications for the Chinese market.

Consulting

China Certification provides a range of specialized consulting services, especially for car manufacturers and large industrial companies. With the consulting packages the certifications as well as internal procedures related to international product certifications can be streamlined.

Company

Since 2005, MPR China Certification GmbH – China Certification Corporation has been supporting companies around the world in obtaining the required product certifications for the Chinese market. With a strong team located worldwide, we can offer you the best solution for your enquiries.

leggi di più

Process of CFDA Application

The following process flow chart provides a brief overview of the CFDA application process and the necessary steps. For a more detailed description of the application process for Chinese medical device registration, please read our free CFDA-booklet.

 

CFDA Application

Process of CFDA Application

 

Based on the risk class, different steps in the application process must be taken with different supporting documents being submitted.

According to the Chinese regulations, re-certification must be done every 5 years.

CFDA Process of the Classification and Registration of Medical Devices

  • Application documents as well as all relevant supporting documentation must be provided. The manufacturer will need to classify their product into Class I, Class II or Class III, based on risk factors.
  • All application and supporting documentation must be submitted to the CFDA. They will review application, supporting documents and classification and accept, reject or re-classify.
  • The medical device will be tested by a CFDA approved test laboratory in China.
  • Legal and technical supporting documentation may be requested.
  • Clinical trials will be conducted (if required).
  • Evaluation of product test and/or clinical trial is done by the CFDA. Final results will be presented in a technical and administrative report.
  • If the device is approved, a certificate of the registration and license will be issued.

Please note that only after handing in all application documents will the CFDA decide whether a medical device registration is possible (usually within 30-60 days after application). There is the possibility that the application is rejected by CFDA, if this should happen an explanation and statement will be provided to the applicant.

Expert CFDA Consultation from China Certification Corporation will reduce the time and expense when seeking CFDA registration for your medical device.

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