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.

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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.

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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.

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.

讲座培训

China Certification Corporation offers customized CCC training to fit your company needs. Our trainer will come to your location and provide the training, up to date information and pass on valuable tips from our many years of experience. Call us today to learn more!

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.

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Criteria to avoid new clinical trials for in vitro diagnostic medical devices

On November 8, 2017, the CFDA (China Food and Drug Administration) issued a notice that aims to facilitate the reference to existing studies in in-vitro diagnostic medical devices. Even further, under certain conditions it may be possible to dispense clinical studies altogether.
The evaluation of the decision that has been made in 2014 has now been completed.
 
The underlying letter specifies, among other things, the scope, basic requirements and test- as well as evaluation methods that must be met in order for existing studies to be recognized.
 
In-Vitro Diagnostic Medical Devices
 
In its core, three main aspects were emphasized :

  1. The responsibility of the applicant. The applicant in particular is responsible and held liable for the verification and authenticity of the collected test data of the respective study.
  2. Chosen studies must show traceability and transparency in the selection of test individuals and samples used.
  3. It is required that all studies were conducted with clear clinical evaluation and test methods. In addition, it is necessary for existing studies to refer to a representative and meaningful control study.

 
For applicants, these decisions can simplify the approval process significantly in the future and reduce both costs and time for CFDA registration .
 
If you have further questions about the new features or regarding CFDA registration in general, please do not hesitate to contact us directly. Please, write us an e-mail or call us, at: +49 (0)69 271 3769 23.

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