2. Outline
1 China Compulsory Certification (CCC)
requirement for Medical Devices
2 Defining Medical Devices
3 Main Contents of the Implementation
Rules for CCC for Medical Devices
4 Standards and Differences for Products
Compulsory Certification
5 Principles of Defining Application Units
6 Working Procedures for Application and
Certification
7 Application for Certification Mark
8 Interpretation on related issues
3. China Compulsory Certification
System for Medical Devices
1) Based on
Regulations of the People’s Republic of
China on Certification and Accreditation
4. China Compulsory Certification
System for Medical Devices
2) Categories:7
1. Medical X-ray Diagnostic Equipment
2. Hemodialysis Equipment
3. Extra corporeal Blood Circuit for Blood
Purification Equipment
4. Hollow Fiber Dialyzers
5. Implantable Cardiac Pacemakers
6. Electrocardiographs
7. Artificial Heart-Lung Machine
5. China Compulsory Certification
System for Medical Devices
3) Enforcement Date
1. Date of formal implementation (beginning to
accept): May 1, 2002.
2. Date of supervision and administration:
August 1, 2003.
Since August 1, 2003, the subject products
must obtain CCC certificates and be applied
CCC marks before imported.
7. China Compulsory Certification
System for Medical Devices
5) Accessibility of CCC documentation
Catalogue, Implementation Rules and
other relevant regulations are public and
transparent.
www.cnca.gov.cn
8. Defining Medical Devices
1. Medical X-ray Equipment
refers to medical devices which use X-ray imaging
for clinical diagnosis or realize operation or
treatment with the aid of X-ray imaging.
It means that medical X-ray imaging equipment is
subject to CCC.
9. 1. Medical X-ray Equipment
includes:
Radiographic X-ray system, Fluoroscopic X-ray system,
Gastrointestinal X-ray system, Mammography X-ray
system, Dental X-ray system, Surgical Imaging X-ray
system, Intervention Treatment X-ray system,
Angiographic X-ray system, X-ray Bone Densitometer,
X-ray Equipment for Computed tomography and other
equipment used the principle of X-ray imaging.
10. 1.Medical X-ray Equipment
The X-ray equipment used the X-ray
biological effect for radiation therapy is not
included in the scope of certification.
11. 2. Hemodialysis Equipment
The hemodialysis equipment is used for
hemodialysis treatment of patients
suffering renal failure.
12. 2. Hemodialysis Equipment
It includes: Hemodialysis Equipment,
Extracorporeal Blood Circuit for Blood
Hemodialysis Equipment, Hollow Fiber Dialyzer.
It does not include the Hemodialysis Equipment
used for treatment of patients suffering liver
failure.
13. 3.Artificial Heart-Lung Machine:
The artificial heart-lung machine is used during
open heart surgery, instead of the living heart-
lung in extra corporeal blood circulation.
14. 3.Artificial Heart-Lung Machine:
The artificial heart-lung machine consisting of
six parts are included in the scope:
1. Artificial Heart-Lung Machine Roller Pump
2. Artificial Heart-Lung Machine Pulsatile Roller Pump
3. Artificial Heart-Lung Machine Bubble Oxygenator (not
including membranous oxygenator)
4. Artificial Heart-Lung Machine Silicon Rubber Pump Tube
5. Artificial Heart-Lung Machine Water Heating/Cooling
System
6. Artificial Heart-Lung Machine Heat Exchanger
15. 4. Implantable Cardiac Pacemakers
The scope includes all implantable cardiac pacemakers,
but not include pacemaker powered by isotope cells.
5. Electrocardiographs
The scope includes detachable electrocardiographs for
diagnostic purposes, vector-cardiographs and equipment
for stress testing.
It does not include cardiac sounds graphs and equipment
monitoring heart.
16. Main Contents of the Implementation
Rules for Compulsory Certification
1. Scope of the products
2. Certification model
3. General requirements for certification including:
a) Principles of defining application unit for certification
b) Type testing and relevant test standards
c) Test samples, safety parts/components and relevant
requirements of testing
d) The requirements for inspection of factory,evaluation of
certification results and approval of certification
e) Follow-up inspection after issuing certificate
17. Main Contents of the Implementation
Rules for Compulsory Certification
4.Maintenance of the certificates and change for
covering product of certificate
5.Use of compulsory certification mark and
management of certificates
18. Certification Model of Compulsory
Certification of Medical Devices
The Certification model of medical Devices is
similar to the international fifth certification
model.
Type testing + Initial inspection of the factory +
Follow-up inspection.
19. Standards and Differences for Products
Compulsory Certification
1. The standards of compulsory certification for
medical X-ray diagnostic equipment are all in
accordance with the China national safety
standards transformed identically from the
IEC electrical safety standards, which issued
as the national compulsory safety standards. It
includes:
20. GB9706.1-1995 Medical electrical equipment
Part 1: General requirements for safety
（IEC 60601-1：1988 Medical electrical equipment- Part
1:General requirements for safety and amendment 1）
GB9706.3-2000 Medical electrical equipment
Part 2: Particular requirements for the safety of high-
voltage generators of diagnostic X-ray generators
（IEC 60601-2-7：1998 Medical electrical equipment-
Part 2:Particular requirements for the safety of high-
voltage generators of diagnostic X-ray generators）
21. GB9706.11-1997 Medical electrical equipment
Part 2: Particular requirements for the safety of X-ray
source assemblies and X-ray tube assemblies for
medical diagnosis
（IEC 60601-2-28：1993 Medical electrical equipment- Part
2:Particalar requirements for the safety of X-ray source
assemblies and X-ray tube assemblies for medical diagnosis）
GB9706.12-1997 Medical electrical equipment
Part 1: General requirements for safety
3. Collateral standard: General requirements for radiation
protection in diagnostic X-ray equipment
（IEC 60601-1-3：1988 Medical electrical equipment-Part
1:General requirement for safety 3. Collateral standard:
General requirements for radiation protection in diagnostic）
22. GB9706.14-1997 Medical electrical equipment
Part 2: Particular requirements for the safety of
associated equipment of X-ray equipment
（IEC 60601-2-32：1994 Medical electrical equipment-Part 2:
Particular requirements for the safety of associated
equipment of X-ray equipment）
GB9706.15-1999 Medical electrical equipment
Part 1: General requirements for safety
1. Collateral standard: safety requirements for medical
electrical systems
（IEC 60601-1-1：1995 Medical electrical equipment-Part 1:
General requirements for safety 1. Collateral standard Safety
requirements for medical systems）
23. GB9706.18-2000 Medical electrical equipment
Part 2: Particular requirements for the safety of X-ray equipment
for computed tomography
（IEC 60601-2-44：1999 Medical electrical equipment-Part 2:
Particular requirements for the safety of X-ray equipment for
computed tomography ）
24. The differences between standards for certification
and international IEC standards
The standard of GB9706.1-1995 includes the amendment 1
(1991-11), and not cover the amendment 2 (1995-3 ).
The standard of GB9706.18-2000 was transformed according
to the IEC standard of IEC60601-2-44-1999. At present, the
GB standard is preparing to be transformed according to the
2.1 edition (2002-11) of the IEC standard.
25. 2. The standards for certification of
hemodialysis equipment
Hemodialysis Equipment is according to the standard:
GB9706.2-1991, which is identical with IEC601-2-
16:1989.change to GB9706.2-2003/IEC60601-2-16:1998
Extracorporeal Blood Circuit for Blood Purification
Equipment is according to the standard: YY0267-1995
Hollow Fiber Dialyzer is according to the standard:
YY0053-1991
26. 3. The standards for certification of Artificial
Heart-Lung Machine consisting of six parts
are as follows:
GB12260-90 for Artificial Heart-Lung
Machine-Roller Pump
GBYY0126-93 for Artificial Heart-Lung Machine-Pulsatile Roller
Pump
GB12261-90 for Artificial Heart-Lung Machine-Bubble Oxygenator
YY91048-99 for Artificial Heart-Lung
Machine-Silicon Rubber Pump Tube
YY91047-99 for Artificial Heart-Lung
Machine-Water Heating/Cooling System
GB12262-90 for Artificial Heart-Lung
Machine-Heat Exchanger
27. 4. The standard for certification of
Implantable Cardiac Pacemakers is
GB16174.1-1996.
It is identical with the standard of ISO 5841-
1989 Cardiac pacemaker-Part 1: Implantable
pacemaker
28. 5. The standard for certification of
Electrocardiographs is GB10793-2000.
It is identical with the standard of IEC60601-2-25:
1993 Medical electrical equipment- Part 2: Particular
requirements
for the safety of electrocardiographs
（IEC 60601-2-25：1993 Medical electrical equipment-
Part 2:Particular requirements for the safety of
electrocardiographs）
29. Principle of Defining Application Units
In principle, one type/model sample should be defined as
one application unit. The products, of same manufacturer,
but from different manufacturing premises, shall be in
different application units.
1. for the active medical electrical equipment, such as the
medical X-ray equipment etc. of which are the same or
similar of safety structure, main parts( assemblies ), and
safety critical components as the same series products
may be defined as one application unit.
30. Principle of Defining Application Units
2.for the passive medical electrical equipment,
such as Hollow fiber dialyzer etc., if the
materials and the processing of the products
are the same as well as the similar structure,
may be defined as one application unit.
31. The type testing shall be carried out on
the typical product to be selected in the
same application unit; for the product
with partial differences, of which only
need the testing.
32. Designated Certification Bodies
and Designated Laboratories
China Quality Certification Center (CQC)
Tel: +86 10 65994215
Address:
No.A10, Chaowai Dajie,
Beijing(100020) P.R.China
Http://www.cqc.com.cn
33. 4 laboratories authorized by CNCA
undertaking the testing work of medical
electrical equipment for certification
according to different categories of products.
34. Designated Certification Bodies
and Designated Laboratories
Liaoning Quality Supervision and Test
Institute for Medical Devices
medical X-ray diagnostic equipment
Shanghai Testing and Inspection Institute
for Medical Devices
electrocardiographs and implantable cardiac
pacemakers
35. Designated Certification Bodies
and Designated Laboratories
Guangzhou Testing and Inspection Institute for
Medical Devices
artificial heart-lung machine and
hemodialysis equipment
Beijing Testing and Inspection Institute for
Medical Devices
electrocardiographs, hemodialysis equipment
(not including extra corporeal blood
circuit for blood purification equipment
and hollow fiber dialyzer).
36. Working Procedures for
Application and Certification
Flow Chart on Application for CCC Certification
Application for certification
Acceptance of application
Testing of samples
Inspection of factory
Evaluation of certification
Issuing of certificates
37. 1. To make an application
The application can be made through the network/on
line.
The network address of CQC: www.cqc.com.cn
The application information and application form in
English edition can be available from the network
page.
38. 2. The applicant should send the relevant
documents to the Department 4 of CQC after
submitting the application. It should at least
includes:
39. Instructions for use, technical description and
service manual.
Product assembly chart, working (electrical)
principle diagram, circuit diagram and parts
diagram.
Product instructions for installation and
adjustment.
Product inspection/testing report (including basis
and method of testing).
40. List of the critical parts for the safety (including
mane, model, specifications, manufacturer,
executive standard and the case of safety
certification).
The applicant shall submit simultaneously the
description of product and of the differences among
types/models of the same application unit.
41. 3. Preparation and testing of samples
In principle, the samples should be sent to the appointive
laboratory for carrying out type testing.
The standards basis for testing samples shall be the
relevant standards listed in the implementation rules for
certification.
for the special case, applicant can make an application for
testing on site;
42. 4. Preparation and implementation on
inspection of factory
Factory quality assurance capability
Consistency of products (name plate, structure,
critical parts)
Witness test, if necessary
Timing of inspection
43. Application for Certification Mark
Issuing and Managing Center for CCC Mark
Tel: 0086-10-65994033
Fax: 0086-10-65994060
www.cnca.gov.cn
44. Interpretation on related issues
Follow up inspection
Procedure for change
Re-assessment on Medical Device
Testing on site
Medical product Standard status
45. Follow up inspection
Content of follow up inspection: assessment
of quality assurance capability, inspection on
consistency of products, and submission of
sampled specimens to test laboratories for
tests, if necessary.
The follow-up inspection shall normally be
implemented at least once per year.
46. Procedure for change
Standard revise on medical device
Implementation rules for CCC medical
device revise
Change of information list on CCC
Certificate
Change on critical component and martial of
the product
Change of design of the product on safety
47. Re-assessment on Medical Device
Samples testing
The testing of supplying samples shall be
compliance with the application unit
Factory quality assurance re-assessment
Timing of re-assessment
after getting the certificate for the fifth year
48. Testing on site
The sample shall be installed on site or test
expeditiously because of hard
After the approval of certification body
satisfy the relevant conditions and possess
facilities for testing samples.
49. Medical product Standard status
GB9706.23-2005 /IEC60601-2-45:2001
Medical electrical equipment-part 2-25
particular requirements for the safety of
mammographic X-ray equipment and mammographic
sterotactic devices
GB9706.23-2005/IEC60601-2-43:2000
Medical electrical equipment-part 2-43
particular requirements for the safety of X-ray
equipment for interventional procedures
