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: CFDA Issues Working Procedures for the Audit of Quality Management Systems for the Registration of Medical Devices

Certain medical products and devices are required to have CFDA registration prior approval by the CFDA (China Food and Drug Administration Chinese: 国家食品药品监督管理总局) before they can be imported, bought, sold, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework of the CFDA registration.

Recently the CFDA issued Working Procedures for the Audit of Quality Management Systems for the registration of Medical Devices in the “Domestic Class III” sector. The Working Procedures stipulate the work linkage between the CFDA technical evaluation institutions and provincial regulatory departments. They also set the formal framework of the auditing system including the required audit documents, the audit timeline, the audit results, and the relation between audit results and product registration evaluation.

In an effort to control and increase the safety of medical devices in China, there have been many regulatory restructuring and revisions of the regulations in recent years. It is important that manufacturers stay up to date with the current regulations. Some of the more recent published updates are as follows:

• March 2014 — The CFDA published a completely new version of their “Regulations for the Supervision and Administration of Medical Devices” (Chinese: 医疗器械 监督管理条例(修订草案)
• July 2014 — The CFDA launched «120 new industry standards for medical devices» (abbreviated as «YY-Standard»).
• 2015 – The CFDA introduced another 90 industry standards (you can find more information on these in our news section).
medical healthcare testThe purpose for these changes is to promote the positive development of China’s medical equipment industry and to ensure the quality and safety of medical products. It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future. In our “News” section on our website, we will keep you informed regarding official announcements and changes to the regulations.

If you want to learn more about CFDA certification for medical devices and products, 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 or email with any questions you may have.

 

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