China Compulsory Certification Requirement And Procedures Of Medical Device

China Compulsory Certification requirement and procedures of Medical Device

China Quality Certification Centre (CQC)Sep. 19, 2006

Outline1 China Compulsory Certification (CCC)

requirement for Medical Devices 2 Defining Medical Devices 3 Main Contents of the Implementation

Rules for CCC for Medical Devices4 Standards and Differences for Products

Compulsory Certification 5 Principles of Defining Application Units6 Working Procedures for Application and

Certification7 Application for Certification Mark8 Interpretation on related issues

China Compulsory Certification System for Medical Devices

1) Based onRegulations of the People’s Republic of China on Certification and Accreditation


2) Categories:71. Medical X-ray Diagnostic Equipment 2. Hemodialysis Equipment 3. Extra corporeal Blood Circuit for Blood

Purification Equipment 4. Hollow Fiber Dialyzers5. Implantable Cardiac Pacemakers6. Electrocardiographs 7. Artificial Heart-Lung Machine


3) Enforcement Date1. 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.


4) Certification Mark


5) Accessibility of CCC documentation Catalogue, Implementation Rules and other relevant regulations are public and transparent.www.cnca.gov.cn

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.

1. Medical X-ray Equipmentincludes: 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.

1.Medical X-ray EquipmentThe X-ray equipment used the X-ray biological effect for radiation therapy is not included in the scope of certification.

2. Hemodialysis EquipmentThe hemodialysis equipment is used for hemodialysis treatment of patients suffering renal failure.

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.

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.

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 Pump2. Artificial Heart-Lung Machine Pulsatile Roller Pump3. Artificial Heart-Lung Machine Bubble Oxygenator (not

including membranous oxygenator)4. Artificial Heart-Lung Machine Silicon Rubber Pump Tube5. Artificial Heart-Lung Machine Water Heating/Cooling

System 6. Artificial Heart-Lung Machine Heat Exchanger

4. Implantable Cardiac PacemakersThe 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.

Main Contents of the Implementation Rules for Compulsory Certification

1. Scope of the products2. Certification model3. General requirements for certification including: a) Principles of defining application unit for certificationb) Type testing and relevant test standardsc) 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

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

Certification Model of CompulsoryCertification 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.

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:

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 equipmentPart 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）

GB9706.11-1997 Medical electrical equipment Part 2: Particular requirements for the safety of X-raysource 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）

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）

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 ）

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.

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/IEC60601-2-16:1998Extracorporeal Blood Circuit for Blood Purification Equipment is according to the standard: YY0267-1995Hollow Fiber Dialyzer is according to the standard: YY0053-1991

3. The standards for certification of Artificial Heart-Lung Machine consisting of six parts are as follows:

GB12260-90 for Artificial Heart-LungMachine-Roller PumpGBYY0126-93 for Artificial Heart-Lung Machine-Pulsatile Roller Pump

GB12261-90 for Artificial Heart-Lung Machine-Bubble OxygenatorYY91048-99 for Artificial Heart-LungMachine-Silicon Rubber Pump TubeYY91047-99 for Artificial Heart-Lung Machine-Water Heating/Cooling SystemGB12262-90 for Artificial Heart-LungMachine-Heat Exchanger

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

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）

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.

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.

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.

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

4 laboratories authorized by CNCA undertaking the testing work of medical electrical equipment for certification according to different categories of products.


Liaoning Quality Supervision and Test Institute for Medical Devices

medical X-ray diagnostic equipmentShanghai Testing and Inspection Institute for Medical Devices

electrocardiographs and implantable cardiac pacemakers


Guangzhou Testing and Inspection Institute for Medical Devicesartificial heart-lung machine and hemodialysis equipmentBeijing Testing and Inspection Institute for Medical Deviceselectrocardiographs, hemodialysis equipment (not including extra corporeal blood circuit for blood purification equipment and hollow fiber dialyzer).

Working Procedures forApplication 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

1. To make an application

The application can be made through the network/on line.The network address of CQC: www.cqc.com.cnThe application information and application form in English edition can be available from the network page.

2. The applicant should send the relevant documents to the Department 4 of CQC after submitting the application. It should at least includes:

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).

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.

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;

4. Preparation and implementation on

inspection of factoryFactory quality assurance capabilityConsistency of products (name plate, structure, critical parts) Witness test, if necessaryTiming of inspection

Application for Certification Mark

Issuing and Managing Center for CCC MarkTel: 0086-10-65994033Fax: 0086-10-65994060www.cnca.gov.cn

Interpretation on related issues

Follow up inspectionProcedure for changeRe-assessment on Medical DeviceTesting on siteMedical product Standard status

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.

Procedure for change

Standard revise on medical device Implementation rules for CCC medical device reviseChange of information list on CCC CertificateChange on critical component and martial of the productChange of design of the product on safety

Re-assessment on Medical Device

Samples testing The testing of supplying samples shall be compliance with the application unitFactory quality assurance re-assessmentTiming of re-assessment after getting the certificate for the fifth year

Testing on site

The sample shall be installed on site or test expeditiously because of hardAfter the approval of certification bodysatisfy the relevant conditions and possess facilities for testing samples.

Medical product Standard statusGB9706.23-2005 /IEC60601-2-45:2001 Medical electrical equipment-part 2-25particular requirements for the safety of mammographic X-ray equipment and mammographicsterotactic devices

GB9706.23-2005/IEC60601-2-43:2000Medical electrical equipment-part 2-43particular requirements for the safety of X-ray equipment for interventional procedures

Thank you for your cooperation!谢谢！

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China Compulsory Certification Requirement And Procedures Of Medical Device