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.

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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 Classification

According to the Regulations for the Supervision and Administration of Medical Devices, Medical Devices are defined as (Guideline 93/ 42/ EWG, Article 1, Paragraph 2, Iss. 2007):

Any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means […].

Medical devices for the Chinese market are classified into three different categories by CFDA. The three classifications are categorized as Class I, Class II, and Class III. For each class, specific administrative procedures, product tests and/or even clinical trials may be required for the approval process.

  • For Class I devices, safety and effectiveness can typically be ensured through documentation, so product tests and clinical trials in China are usually not required.
  • For Class II devices, safety and effectiveness can be ensured through documentation and product testing. Some Class II devices may require clinical trials.
  • Class III devices which are usually implanted into the human body or are used for life support or sustenance, can pose a potential risk to the human body and are strictly controlled by mandated tests and clinical trials to ensure their safety and effectiveness.

CFDA classification

It can be difficult for medical device manufacturers to determine whether their products require certification and in which class their products should be categorized. In our CFDA-Booklet you can find more information about the three different classifications.

A complete evaluation of CFDA-responsibility and classification simplifies your registration process and prevents additional, unplanned costs.

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

 

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