Regulations of China Medical Device Sunjingsheng Beijing institute of medical device testing

1. Regulations of China Medical Device Sunjingsheng Beijinginstituteofmedicaldevicetesting 2013.11 1

2. ---Brief Introduction of BIMT • BIMT, with its former name Beijing Medical Device Testing Station , was established in 1983 and it was attached to the former Beijing Medical Equipment Institute. • BIMT has reformed into a public institution with independent judicial person since 2000, which was an affiliate of BJDA . • Same time It is a subordinate agency of SFDA.

3. Registration Supervision Import& Export Certification Entrust … ----Testing Capacity • As a national medical device testing center, BIMT undertakes the assignments such as registration testing, supervision sampling testing of medical device testing, CCC compulsory safety certification testing, testing of import & export commodities, certification testing, entrusted testing and arbitration testing in and out of China.

4. Content 1.Present situation of CFDA 2. Present medical device regulations system 3. Present medical device standards system

5. Control of all life cycle MD life cycle＝R&D－Manufacture －sales－use－service－disposal Before market Products registration Manufacturer approved Surveillance for products： such as sampling testing, Recall,Adverse events. Post market Surveillance for behaviors (GMP): Such as quality systems, distribution,use,disposal 5

6. Present situation of CFDA China food and drug administration Department of Medical Device Registration Department of Medical Device supervision Department of Science, Technology and Standards Division of Monitoring and Re-evaluation General Affairs Manufacturing Supervision Distribution Supervision Research Supervision Registration I Registration II General Affairs

7. Department of Medical Device Registration • To conduct registration for Class III and import medical devices in strict accordance with the conditions and procedures prescribed by law, take the correspondent responsibilities, optimize registration control procedures, organize and implement classification administration, and supervise the implementation of good practices for medical devices.

8. Department of Medical Device Supervision • To track and analyze medical device safety situation and existing problems, and to put forward recommendations on system, mechanism and performance improvement; to supervise the low-level administrative departments in conducting administrative licensing by law, in performing the administrative duty, in detecting and rectifying illegal and improper acts in time; to organize and conduct medical device adverse events monitoring and reevaluation.

9. Department of Science, Technology and Standards To organize and implement major science and technology programs for food and drug supervision, accelerate the construction of food and drug testing system, electronic supervision tracking system, and information system; to draft qualification requirements and testing norms governing food and drug testing institutions, and supervise their implementation; to organize the drafting of standards for drugs, medical devices, cosmetics, and catalogues, pharmaceutical use requirements, standards for immediate packaging materials and containers, and participate in the drafting of food safety standards.

10. Technical Support institutes • Center of Medical Device Evaluation • Center of Medical Device Standards Management • Medical Device Standards Technical Committees • Institute of Medical Device Testing • Center of Drug Adverse Events Monitoring and Reevaluation.

11. Characteristics of structure reform • Strengthen post market supervision • Stress on R&D and standards

12. Medical device regulation system Regulations for the Supervision and Administration of Medical Devices Regulation ORDERNO.10\15\16 Order Normative Document provision\lists Guidances

13. Regulations for the Supervision and Administration of Medical Devices • 条例： Regulations for the Supervision and Administration of Medical Devices State council directive NO.276 2000.01.04 Release 2000.04.01 implement

14. Regulation of medical device

15. Technical guidances 国家食品药品监督管理局发布的医疗器械技术审评指导原则 第二类纤维内窥镜产品注册技术审查指导原则第二类硬管内窥镜产品注册技术审查指导原则中频电疗产品注册技术审查指导原则B型超声诊断设备（第二类）产品注册技术审查指导原则心电图机产品注册技术审查指导原则电动手术台指导原则磁疗产品注册技术审查指导原则电动病床产品注册技术审查指导原则3A类半导体激光治疗机产品注册技术审查指导原则电子血压计（示波法）产品注册技术审查指导原则红外乳腺检查仪产品注册技术审查指导原则注射泵产品注册技术审查指导原则超声理疗设备产品注册技术审查指导原则牙科综合治疗机产品注册技术审查指导原则 15

16. Medical Device Classification • The State shall classify medical devices and administer them based on this classification • Class I Medical Devices are those for which safety and effectiveness can be ensured through routine administration; • Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness • Class III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential

20. Order NO.15Provisions for Medical Device Classification • Article3 The Provisions are meant to direct the formulation of The Category of Medical Device Classification as well as to determine the classes of newly registered products. • Article 4 The classification of medical devices should be determined by a combined judgement on three respects: its structural characteristics, form of operation as well as conditions for use.Specifically, their classification can be based on Criteria for Medical Device Classification (see appendix).

21. The Category of Medical Device Classification www.sfda.gov.cn [2002]NO.302 2002-09-05release Annex The Category of Medical Device Classification

22. Registration of MD －registration of MD refers to MD must approval by drug regulatory authority before access to market. －CMDE response for evaluation of application documents （Center of MD Evaluation - CMDE） －DMDR response for approval of application （Department of MD registration） －Registration certification valid period is 4 years. 22

23. Classification registration Article 8 The State shall implement a product registration system for the manufacturing of medical devices. Class I medical devices shall be inspected, approved and granted with a registration certificate bythe drug regulatory authority of the government of the municipalities consisting of districts. Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government. Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council. Importing MD shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council. 23

24. Provisions for Medical Device Registration － total9chapters,56 Articles,12Annexs. － actually registration orders ,convenience for Applicants. － add re-registration, Modify\Replacement certification － 12 Annexs have same legal effect. － greater legal accountability efforts － concisely phrase, Easy to understand.

25. Registration process

26. －Category national standard(GB, GB/T) mandatory(GB, YY、YZB)、 industrial standard(YY, YY/T) recommend(GB/T, YY/T) registration product standard(YZB)。 －until DEC.2012,There are 1050MD standards，of which national standards180，of which mandatory standards90； industrial standards 870，of whichmandatorystandards320. Standards of china MD 26 26

27. Standardized technical committee There are 22 standardized technical committees being response for drafting and revising national and industrial standards

28. RPS － MD Should have RPS including national standards and industrial standards，but requirements of RPS shall not be lower than requirements of national and industrial standards. － manufacturers are responsible for RPS. － Chinese authority address “RPS is industrial standard ,if no corresponding national or industrial standard” 28 28

29. Structure of RPS • Scope • Normative references • Classification and composition • requirement • Method of testing • rule of testing • labeling、symboland instruction • packing、transportationand storage • RPS explanation

30. thanks！