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Regulations of China Medical Device
SunjingshengBeijing institute of medical
device testing2013.11
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.
---Brief Introduction of BIMT
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.
----Testing Capacity
Import&Export
RegistrationSupervision
Certification
Entrust
…
Content
1.Present situation of CFDA
2. Present medical device
regulations system
3. Present medical device
standards system
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Control of all life cycle
Products registration
Manufacturer approved
Surveillance for products :such as sampling testing,Recall,Adverse events.
Surveillance for behaviors (GMP):Such as quality systems, distribution,use,disposal
Post market
Beforemarket
MD life cycle = R&D - Manufacture - sales - use - service -disposal
Present situation of
CFDA
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China food and drug administration
Department of Medical Device RegistrationDepartment of Medical Device supervision
Registration I Registration II General Affairs
General Affairs
Department of Science, Technology and Standards
Research Supervision
Manufacturing Supervision
Distribution Supervision
Division of Monitoring and Re-evaluation
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.
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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.
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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.
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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.
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Characteristics of structure reform
• Strengthen post market supervision• Stress on R&D and standards
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Medical device regulation system
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Regulation
Normative Document
Guidances
Regulations for the Supervision and Administration of Medical Devices
ORDER NO.10\15\16
Order
provision\lists
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
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Regulation of medical deviceorder name Date of
ImplementNO.5 Provision of medical device clinical trail 2004- 04- 01
NO.10 Provision of medical device instruction 2004- 07- 08
NO.12 Good manufacture procedure of medical device
2004- 07-20
NO.15 Provisions for Medical Device Classification
2000- 04-10
NO.13 Provisions for Medical Device distribution 2004- 08-09
NO.16 Provision of medical device registrition 2004- 08-09
NO.17 Provision of new medical device approval 2000- 04-20
NO.22 Provision of Medical device quality system audit
2000- 07-01
NO.24 Provision of single use medical device supervision
2000- 10-13
NO.31 Provision of medical device standard 2002- 05- 01
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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
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
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Order NO.15 Provisions 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).
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6801 Basic surgery device
6802 Micro-surgery device
6803 Neurosurgery device
。。。 。。。。。。6821 Electrical medical device
6822 Optical and endscope
6823 Ultrasound medical device
6824 Laser medical device
。。。 。。。。。。6832 High energy ray equipment
6840 IVD system
6841 Medical laboratory device
6858 Medical cooling therapy and storage equipment
6863 Dental material
。。。 。。。。6870 Medical software
6877 Implant device
The Category of Medical Device Classification
www.sfda.gov.cn
[2002]NO.3022002-09-05release
AnnexThe Category of Medical Device
Classification
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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.
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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 by the 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.
Provisions for Medical Device Registration
chapter content article
一 General provision 1 ~ 8
二 Registration testing of MD 9 ~ 15
三 Clinical trail of MD 16 ~18
四 Registration application and approval
19 ~32
五 Re-registration 33 ~37
六 Modify\Replacement certification 38 ~41
七 supervision 42 ~45
八 Legal responsibility 46 ~50
九 Supplementary article 51 ~56
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- total 9 chapters,56Articles,12 Annexs.- actually registrationorders ,convenience for Applicants.- add re-registration, Modify\Replacement certification- 12 Annexs have same legal effect.- greater legal accountability efforts- concisely phrase,Easy to understand.
Registration process
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- 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 1050 MD standards , of
which
national standards 180 , of which mandatory
standards90 ; industrial standards 870 , of
whichmandatorystandards320.
Standards of china MD
Standardized technical committee
number name secretariat
1 TC 136 IVD BIMT
2 TC 10/SC1
X ray equipment Liaoning
3 TC 10/SC3
Radiotherapy & nuclear
BIMT
4 TC 10/SC2
Ultrasound equipment
Hubei
5 TC 10 /SC4
Physical therapy Tianjin
6 TC 10/SC5
Electrical medical device
shanghai
7 TC 94 Surgery device shanghai
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There are 22 standardized technical committees being response for drafting and revising national and industrial standards
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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”
Structure of RPS
1. Scope
2. Normative references
3. Classification and composition
4. requirement
5. Method of testing
6. rule of testing
7. labeling 、 symbol and
instruction 8. packing 、 transportation and
storage 9. RPS explanation
•thanks !
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