CCC MARK APPROVAL

ccc mark approval

CCC stands for China Compulsory Certification.

The CCC mark is the new compulsory Safety & Quality mark for many products sold on the Chinese market. CCC Mark became effective on May 1, 2002. It is the result of the recent integration of China's two compulsory inspection systems (one to check contents of products for import and export, and the other for quality control) into a single procedure. The new CCC mark replaces the two old marks, namely CCIB and CCEE used in the two old inspection systems.

 

The Challenging process of Medical device registration for the Chinese market makes it necessary to have a partner with Chinese market experience and expertise in providing insights into how to manage and direct you through the regulatory process in China's developing regulatory activities.

Registration- Medical device and IVD

In China, medical devices are controlled by the National Medical Product Administration (NMPA). Before marketing or exporting into China, manufacturers must register their medical devices with the NMPA. The NMPA has consistent guidelines, reporting, and clinical data requirements in reviewing all applications and submissions. The documentation needed for your NMPA submission is determined by your device classification.

  • Class I: only registration filing without device test reports
  • Class II: complete registration filings including device test reports
  • Class III: Complete registrations filings including device test reports

China needs inland testing for most Class II and III devices, with very few exceptions. The conditions for testing vary depending on the type of device. E&E medicals and consulting will help you get your medical device and IVD's regulatory approved into the Chinese market. Our experts work directly every day with the NMPA, organize the submission of regulatory documents, and answer follow-up questions from the NMPA. Despite China’s challenging market, our consultants located in China have a broad experience in meeting your goals.

The Challenging process of Medical device registration for the Chinese market makes it necessary to have a partner with Chinese market experience and expertise in providing insights into how to manage and direct you through the regulatory process in China's developing regulatory activities.

Registration- Medical device and IVD

In China, medical devices are controlled by the National Medical Product Administration (NMPA). Before marketing or exporting into China, manufacturers must register their medical devices with the NMPA. The NMPA has consistent guidelines, reporting, and clinical data requirements in reviewing all applications and submissions. The documentation needed for your NMPA submission is determined by your device classification.

  • Class I: only registration filing without device test reports
  • Class II: complete registration filings including device test reports
  • Class III: Complete registrations filings including device test reports

China needs inland testing for most Class II and III devices, with very few exceptions. The conditions for testing vary depending on the type of device. E&E medicals and consulting will help you get your medical device and IVD's regulatory approved into the Chinese market. Our experts work directly every day with the NMPA, organize the submission of regulatory documents, and answer follow-up questions from the NMPA. Despite China’s challenging medical device or IVD registration process, our consultants located in China have a broad experience in meeting your goals.

 

Our experts and partners who are Authorized Representatives identify hazards, assess risks, carry out all applicable tests to determine the appropriate measures to meet with CCC Certification mark regulations.

To learn more about CCC mark approval, contact us today