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.

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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.

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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.

TRAINING

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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CFDA: Priority Review Procedure for Medical Devices

The China Food and Drug Administration (CFDA) issued a draft of regulation for priority review for medical device manufacturers. The circular proposes the qualifying criteria, process and features of the priority review. The public was able to comment the draft until July 20th 2016.

In China it is necessary that manufacturers of class II and class III medical devices follow a strict technical review. This technical review is done by the Centre for Medical Device Evaluation (CMDE). This is necessary before the devices can be shipped to China.

The priority review should give the applicants shorter review time in the registration process. According to the circular, applicants with class II medical devices (only foreign applicants) or class III medical device manufacturers (both domestic and foreign applicants) can request a priority review in some cases. First of all, a priority review is possible if the device is part of the National Science and Technology Major Project or the National Key Research and Development Plan. Priority review is also possible if a medical device can:

  • diagnose or treat a rare disease and has outstanding advantages in clinical practice
  • diagnose or treat malignant tumors and has outstanding advantages in clinical practice
  • diagnose or treat a specific disease that frequently occurs in the elderly and there is no other effective way to diagnose or cure such disease
  • diagnose or treat a specific disease that frequently occurs in children and there is no other effective way to diagnose or cure such disease
  • address an urgent clinical need and the same type of device has not yet been marketed in China

The CMDE will decide whether a specific medical device is able to receive priority review. If a device is not eligible to receive priority review, they have to follow the standard review process. If a device receives priority review the applicant is able to make use of features which shorten the technical review process. As it can be seen, the CFDA is trying to introduce new approaches which can improve the registration process. Therefore, medical device manufacturers should monitor changes constantly.

You can find further information about our services for CFDA registration on our website.

It is expected that there will be more announcements, revisions and changes to the CFDA regulations in the near future. You will find updated information in our news section on our website, where we will keep you informed regarding official announcements.

If you want to learn more about CFDA registration for medical devices, please visit the CFDA section on our website. We also provide more detailed knowledge regarding CFDA in our free brochure “CFDA China – The Booklet” that can be downloaded here.

Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or email and we will be happy to answer questions.

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