China Compulsory Certification (CCC)
The CCC mark is the new compulsory Safety & Quality mark for many products sold on the Chinese market. CCC Mark Approval 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 approval 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 Devices and IVD
The NMPA has consistent guidelines, reporting, and clinical data requirements in reviewing all applications and submissions.
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 approval 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.
Why choose E & E Medicals and Consulting?
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. Carry out all applicable tests to determine the appropriate measures to meet with CCC certification mark regulations.