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.

Lire la suite

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.

Lire la suite

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.

Lire la suite

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.

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.

Lire la suite

CFDA: New Regulation Published for Quality Management of Medical Devices

An ageing population and improved living standards have created a strong demand for medical devices in China. The safety of those products is ensured by the China Food and Drug Administration (CFDA, chin: 国家食品药品监督管理总局). At the 16th and 17th minister’s working meeting new and revised regulations governing the good practices in supply and medical device manufacturing were adopted. The new requirements are aimed at improving the quality and safety of related medical products.
Team of surgeons in the operating room, female surgeon holdingThe new supply practice went into effect December 12, 2014 and includes 66 articles in 9 chapters. The new requirements are in regards to the quality management of companies producing medical devices. There are more stringent control process covering the purchase, acceptance, storage, sales, transportation and the after-sales service of medical devices.

The revised practice for manufacturing medical devises includes 84 articles in 13 chapters and will go into effect March 1, 2015. The new requirements are aimed at improved quality management at the manufacturing level. These requirements cover personnel, manufacturing facilities, manufacturing equipment, document management, product design and development, procurement, production management, quality control, sales, after-sales service, control of non-conforming products, adverse event monitoring and more.
It is the responsibility of the manufacturer of medical devices to keep up to date with the latest regulations and to maintain compliance. Manufacturers found out of compliance risk fines and/or suspension or revocation of their CFDA registration. To avoid this, it is important to check the revised practices against your current procedures.

As soon as new announcements or information by the CFDA becomes available, we will provide the information in our News-Area. There you can find all relevant information published by other Chinese authorities.

Do you need more information about certifying medical devices through the CFDA? Learn more at our CFDA-Area on our homepage. For more detailed information you can download our “CFDA booklet” free of charge.

If you would like to know more, have questions or concerns, please contact us any time by phone or email .

 

Third party cookies & scripts

This website uses third-party cookies and scripts (e.g., embedded videos). For optimal performance, it is recommended that you agree to third party cookies and scripts. For more information, see privacy policy and the imprint.Do you agree to the use of cookies & scripts?

Okay

Click here if you do not want to use cookies & scripts.

You can change your settings at any time under Privacy