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: CFDA Releases New Self-Assessment Reporting Requirements for Medical Device Distributors

On June 7, 2016, the China Food and Drug Administration (CFDA) released the Notice on Regulating Distribution Activities in Medical Device Circulation. This Notice requires that distributors of Class II and Class III devices verify that they have been in compliance with “Medical Device Good Supply Practices” (GSPs) and other medical device regulations, for the past two years. Distributors are required to submit a self-assessment to the respective municipal CFDA by July 15, 2016.

In the course of the reports the distributors have to describe any violations and submit a plan on how to avoid them in the future. Egregious violations can result in stricter or even additional inspections done by municipal authorities, but the submission of a correct report can minder the sentence. The report should be truthful, since wrong information the omission of information can lead to penalties such as loss of license and other sanctions.

The self-assessment should focus on eight categories of violations:

  1. Relationships with unqualified suppliers, downstream distributors, and healthcare institutions
  2. Failure to comply with Medical Device Good Supply Practice requirements
  3. Errors during the fabrication of application documents
  4. Failure to obtain or renew distribution licenses for Class III devices
  5. Distribution of unlicensed products (particularly by domestic agents for imported devices)
  6. Distribution of products that fail to meet mandatory standards, technical requirements, or are obsolete or expired
  7. Failure to transport and store medical devices in accordance with their labels and package inserts
  8. Failure to establish and implement the appropriate testing and record keeping system for incoming and outgoing products.

When the distributor submits the report the municipal CFDA, the municipal CFDA will make an inspection. The municipal CFDAs then submits their report to the central CFDA. The central CFDA in Beijing will use this report for their own inspections. It is important that the reports be complete and accurate to avoid additional scrutiny and possible problems.

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 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 (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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