'Regulations for the Supervision and Administration of Medical Devices' provide mandatory safety certification system for part class III medical devices in China. Specific product directory in it is set down by State Food and Drug Administration and General Administration of Quality Supervision, Inspection and Quarantine of China.

1. The scope of application of products and implementation rules

At present, the Class III medical devices involved in CCC Certification System includes 8 categories of medical equipment products namely medical X-ray diagnostic equipments, hemodialysis devices, hollow fiber dialyzer, cardiopulmonary bypass pipelines for blood purification device, electrocardiograph, implantable pacemaker, rubber condoms and artificial heart-lung machine. Different implementation rules for these products have been set down respectively by National Certification and Accreditation Administration (see table below). It provides mandatory technical requirements for the securities of related products; at the same time, it also defines detailed provisions for compulsory certification of application unit, product type test, the inspection/certification/approval of manufactory, the supervision of certified enterprise, the specific use of trademark, the modification/expansion/ fee of certification etc. These enforcement regulations can be regarded as technical basis documents by which a series of activities such as the implementation of certification system of certification bodies, applicants' applications for certification and the supervision of specific products implemented by local law enforcement agencies can be carried out smoothly.

Product category	Product name and remarks	Implementation rule No
Electrocardiograph	ECG recorder	CNCA-08C-032:2001
Hemodialysis device	Kidney dialysis equipment (artificial kidney)	CNCA-08C-033:2001
Cardiopulmonary bypass pipelines for blood purification device	Other medical, surgical and veterinary apparatus	CNCA-08C-034:2001
Hollow fiber dialyzer	Other medical, surgical and veterinary apparatus	CNCA-08C-035:2001
Implantable pacemaker	Pacemaker, does not include parts and accessories	CNCA-08C-036:2001
Medical X-ray diagnostic equipment	Other dental X-ray equipments	CNCA-08C-037:2001
	Other medical and dental X-ray equipments
	X-ray tomography instrument
Artificial heart-lung machine roller pump	Other medical, surgical and veterinary apparatus	CNCA-08C-038:2001
Artificial heart-lung machine roller throb pump	Other medical, surgical and veterinary apparatus	CNCA-08C-039:2001
Artificial heart-lung machine bubble oxygenator	Other medical, surgical and veterinary apparatus	CNCA-08C-040:2001
Artificial heart-lung machine heat exchanger	Other medical, surgical and veterinary apparatus	CNCA-08C-041:2001
Artificial heart-lung machine heat exchanging water tank	Other medical, surgical and veterinary apparatus	CNCA-08C-042:2001
Artificial heart-lung machine silicon rubber pipe	Other medical, surgical and veterinary apparatus	CNCA-08C-043:2001
Rubber condom	Vulcanized rubber condom	CNCA-06C-030:2005

According to the corresponding implementation rules of products, all medical devices involved in CCC Certification System should adopt same certification mode namely 'product type test£«initial factory inspection£«supervision of certificated enterprises'. After obtaining CCC certification, certification marks should be affixed to the prominent positions on the certified products. At present, certification marks used by all certified products involved in CCC Certification System should adopt mark below:

2. Certification bodies for the CCC certification of medical devices

China has two certification bodies for the CCC certification of medical devices namely China Quality Certification Center and Beijing Zhonghua Combination Quality Certification Center:

1. The main scope of application of certification of medical device products involved in China Quality Certification Center includes CNCA-08C-032: electrocardiograph; CNCA-08C-033: hemodialysis devices; CNCA-08C-034: cardiopulmonary bypass pipelines for blood purification device; CNCA-08C-035: hollow fiber dialyzer; CNCA-08C-036: implantable pacemaker; CNCA-08C-037: medical X-ray diagnostic equipments; CNCA-08C-038: artificial heart-lung machine roller pump; CNCA-08C-039: artificial heart-lung machine roller throb pump; CNCA-08C-040: artificial heart-lung machine bubble oxygenator;CNCA-08C-041: artificial heart-lung machine heat exchanger CNCA-08C-042: artificial heart-lung machine heat exchanging water tank; CNCA-08C-043: artificial heart-lung machine silicon rubber pipe.
2. The main scope of application of certification of medical device products involved in Beijing Zhonghua Combination Quality Certification Center (original China Certification Committee and Certification Center of Tire Products and China Committee for Conformity Certification of Latex Produces) includes: CNCA-06C-030: rubber condom.

3. Testing laboratories for the CCC certification of medical devices

China has following six testing laboratories for the CCC certification of medical devices:

1. Beijing Medical Device Inspection Center (Authorization No: 52): The main scope of application of certification of medical device products involved in it includes CNCA-08C-032: electrocardiograph; CNCA-08C-033: hemodialysis devices.
2. Liaoning Medical Device Quality Supervision and Inspection Center (Authorization No: 53): The main scope of application of certification of medical device products involved in it includes CNCA-08C-037: medical X-ray diagnostic equipments.
3. Guangdong Medical Device Quality Supervision and Inspection Center (Authorization No: 54): The main scope of application of certification of medical device products involved in it includes CNCA-08C-033: hemodialysis devices; CNCA-08C-034: cardiopulmonary bypass pipelines for blood purification device; CNCA-08C-035: hollow fiber dialyzer; CNCA-08C-038: artificial heart-lung machine roller pump;CNCA-08C-039-2001: artificial heart-lung machine roller throb pump;CNCA-08C-040: artificial heart-lung machine bubble oxygenator;CNCA-08C-041: artificial heart-lung machine heat exchanger CNCA-08C-042: artificial heart-lung machine heat exchanging water tank;CNCA-08C-043: artificial heart-lung machine silicon rubber pipe.
4. Shanghai Medical Device Quality Supervision and Inspection Center (Authorization No: 55): The main scope of application of certification of medical device products involved in it includes CNCA-08C-032: electrocardiograph; CNCA-08C-036£ºimplantable pacemaker.
5. Zhuzhou Medical Device Quality Supervision and Inspection Center (Authorization No: 45): The main scope of application of certification of medical device products involved in it includes CNCA-06C-030: rubber condom.
6. Contraceptive Products Quality Supervision and Inspection Center of National Population and Family Planning Commission (Authorization No: 118): The main scope of application of certification of medical device products involved in it includes CNCA-06C-030: rubber condom. In 2006, In order to coordinate and resolve the issues of repeated test and double charge brought about by the registrations and the mandatory certifications of eight categories of medical device products above such as medical X-ray diagnostic equipment, General Administration of Quality Supervision, Inspection and Quarantine of China issued 'the notice on the inspection-related problems of part medical device products' (2006, No. 70). The notice pointed out that medical device enterprises should apply for inspection at designated inspection centers if the eight categories of medical device products above need inspections for registration and national compulsory product certification at one time; in the process of inspection, for those same test items, the designated inspection bodies just test the products one time and charge fee for this test, and thus repeated test and double-charge can be avoided finally. The designated inspection centers, according to corresponding test results, should provide registration test report and compulsory product certification test report for enterprises respectively; after obtaining corresponding test reports, according to relevant provisions, the enterprises can apply for registration of medical device at the Food and Drug Supervision and Management Departments; at the same time, they also can apply for national compulsory product certification at the certification bodies which are designated by National Certification and Accreditation Administration Departments.

4. Recognition of results of voluntary product certification of parts which are tested along with whole machine

Once the key parts of medical electrical equipments which need to be tested along with whole machine in the compulsory product certification directory such as switches, non-rewirable plugs, power cords and interference suppression capacitor etc obtained the results of a voluntary product certification which accord with following conditions, then it will be recognized by CCC certification and the separate test for them are unnecessary.

According to certification mode (product type test+initial factory inspection£«supervision of certificated enterprises) which is same with that of the certification of whole machine, the certification bodies approved by the Certification and Accreditation Administration of China and China National Accreditation Board (CNAB) carry out certifications and provide the certificates of voluntary product certification for enterprises; in addition, the inspection bodies for CCC certification which appointed by the Certification and Accreditation Administration of China should provide corresponding test reports which are not beyond the approved limits of certification; moreover, the corresponding test standards for the certification of parts must accord with that of implementation rules of CCC certification.