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.

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: Amended regulations pose a big challenge to manufacturers of medical devices

The amended regulations for registration of medical devices pose a challenge to manufacturers due to the lack of transparency. This non-transparency is based mainly in the fact that there are no English translations and/or the details are often lost when translated. Since most documents and announcements of the Chinese authorities are only available in Chinese, it is difficult for manufacturers to stay current with regulatory amendments and changes.

The last amendments of the China Food and Drug Administration (CFDA, Chinese: 国家食品 药品监督管理总局) regarding the Supervision and Administration of Medical Devices (Chinese: 医疗器械监督管理条例(修订草案)) were announced in February 2014 and published (in Chinese) the following month (March 2014).

The new regulatory amendments affect both the manufacturer planning to start the certification process, as well as manufacturers who have already started the certification process. Manufacturer already in the certification process are placed in a difficult position because they will have to quickly adapt their ongoing certification process to the new regulations. These changes typically result in delays and higher costs for the manufacturers to complete their certification.

Portrait of two surgeons wearing surgical masks in the operating

Based on the last amendments, a stricter monitoring system and a higher degree of penalties will be enforced.

Three major changes will take place:
• A monitoring system will be set up to identify adverse events.
• A reappraisal mechanism will be implemented for registered products.
• A product recall system will simplify withdrawing flawed products from the market.

Consequences for non-compliance will be stricter under the new regulations. Manufacturing, distribution and usage of unregistered high-risk medical devices will result in increased penalties. Furthermore, medical devices without official registration and/or certification will be confiscated. Penalties of up to 20 times the value of the medical devices, as well as criminal charges are possible for manufacturers, distributors and buyers, depending on the severity of the risk imposed by the faulty or unregistered products.

China Certification will continue to inform you about amendments in regulations concerning the CFDA registration process.

If you want to learn more about CFDA certification of 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 contact us by phone (UK: +44 2071931135,
US: +1 773 654-2673) or email us with any questions you may have.

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