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: Amendments in the official “Regulations for the Supervision and Administration of Medical Devices”

The sale and/or use of some medical products and medical devices in China require prior testing and approval from the China Food and Drug Administration (CFDA, Chinese: 国 家 食 品 药 品 监 督 管 理 总 局 ). If used in a doctor’s office or hospital they need to be certified by CFDA and registered in the official CFDA database. The regulatory system for registration of medical devices is based on the Provisions of the Chinese State Council and on the Normative CFDA Documents, which contain detailed rules for medical device registration and licensing. The Regulations for the Supervision and Administration of Medical Devices (Chinese: 医疗器械监督管理条例(修订草案)) from April 1, 2000 also belong to this regulatory framework.

Recently, there have been changes made in regards to these regulations.

According to an official CFDA announcement from February 13, 2014 (Chinese version), respectively February 17, 2014 (English version), the draft of the revised version is composed of 80 articles in eight chapters.
One of the key amendment changes can be found at the very beginning, of chapter one: “General Provisions”. Both the definition of medical devices and the classification criteria (regarding to the three risk classes I-III) have been modified. These changes are very important for manufacturers who currently have CFDA certification and for those who are planning to do so, since the definition changes may affect the need for certification. Devices or products that once needed certification may no longer need it, whereas devices or products that previously did not need certification my now need it.

Adaption of the classification criteria might also have a deep impact for applicants of CFDA certification. Up to this point, the criteria were based on the European Council Directive 93/42/EEC. For each product class (I-III) the CFDA requires specific administrative procedures, product tests and/or clinical trials. Class I devices may only be required to pass relatively simple administrative and approval procedures to seek authorization for Chinese market, while class II and III devices need product testing and possible clinical trials. Due to the upcoming adjustments required approval procedures may change in the future. Depending on how the device or product is reclassified the severity of the tests may either increase or decrease, possibly pushing a device into clinical trials where it previously only needed simple lab tests, or vice versa.

Besides the amendments mentioned above, new restrictions and provisions have been defined in the course of changing the regulations. The modifications affect the following areas:

  • Quality supervision and risk control during production process of medical devices
  • Adverse event monitoring, retracing and recall of medical devices
  • Application for licenses and permissions for distribution of medical devices in China
  • Punishments and fines for illegal activities

The draft amendment to the Regulations for the Supervision and Administration of Medical Devices was adopted in an executive meeting of the Chinese State Council on February 12, 2014.

Until now, the updated regulations have neither been promulgated nor officially implemented, however the CFDA has announced that they will be enforced in the near future.

As soon as the CFDA publishes complete, official announcements regarding these changes we will inform you in our “News” section on our website. Please check our website regularly for up to the date and breaking announcements and planned announcements.
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 call or email with any questions you may have.

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