The China Compulsory Certificate mark, commonly known as CCC Mark (Figure 1), is a compulsory safety mark for many products. The CCC mark is required for both domestically manufactured products and products imported into China. The CCC mark is an import license for enterprises outside of China. When the import products arrive at the Chinese border, the customs officer will check whether the import product is within the mandatory licensing scope and whether a CCC mark is affixed to the import product.
Figure 1 China CCC mark certification
Applying for the CCC mark is required in addition to SFDA registrations for specified medical devices. There are eight types of medical devices must be certified before they may be marked in China. They are:
1) Electrocardiographs
2) Hemodialysis equipment
3) Extracorporeal blood circuit for blood purification equipment/blood purifying device
4) Hollow fiber dialyzer
5) Implantable cardiac pacemakers
6) Medical X-ray diagnostic equipment
7) Rubber condom
8) Artificial heart lung machine
The CCC mark application process includes type testing of the medical device and a facility audit from the CQC.
According to National Implementation Rules for Compulsory Certification of Medical Device, if the certificate maintains in effective, the certified products must be re-evaluated on the fifth year after issuing date. According to this rules, for the medical devices which got CCC certificate on 2008, should accept re-assessment since 2012 (the certified year take certificate number as a standard, that is, the top four certificate number is 2008), and re-assessment should be finished within five years after initial issuing date. For the medical devices which got CCC certificate on 2003, should accept the second re-assessment since 2012 (that is, the top four certificate number is 2003), and re-assessment should be finished within five years after the end date of first re-assessment. CQC will suspend or withdraw the certificates for those fail to complete re-assessment.
For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn
