Your SlideShare is downloading. ×
China Compulsory Certification Requirement And Procedures Of Medical Device
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×

Introducing the official SlideShare app

Stunning, full-screen experience for iPhone and Android

Text the download link to your phone

Standard text messaging rates apply

China Compulsory Certification Requirement And Procedures Of Medical Device

1,005
views

Published on

Author:Mr. Chen Xin …

Author:Mr. Chen Xin
China Quality Certification Centre (CQC)
Sep. 19, 2006

Published in: Business, Health & Medicine

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
1,005
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
29
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. China Compulsory Certification requirement and procedures of Medical Device China Quality Certification Centre (CQC) Sep. 19, 2006
  • 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.
  • 6. China Compulsory Certification System for Medical Devices 4) Certification Mark
  • 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
  • 50. Thank you for your cooperation! 谢谢!