Transcript 医疗器械法规和管理 - Città della Scienza

Regulations of China
Medical Device
Sunjingsheng
Beijing institute of medical
device testing
2013.11
1
---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.
----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.
Registration
Supervision
Import&
Export
Certification
Entrust
…
Content
1.Present situation of CFDA
2. Present medical device
regulations system
3. Present medical device standards
system
4
Control
of all life cycle
MD life cycle＝R&D－Manufacture －sales－use－service－disposal
Products registration
Before
market
Manufacturer approved
Post
market
Surveillance for products：
such as sampling testing,
Recall,Adverse events.
Surveillance for behaviors (GMP):
Such as quality systems, distribution,use,disposal
5
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
Registration I
General Affairs
Registration II
Manufacturing
Supervision
General Affairs
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Distribution
Supervision
Research
Supervision
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.
7
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.
8
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.
9
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.
10
Characteristics of
structure reform
• Strengthen post market supervision
• Stress on R&D and standards
11
Medical
device regulation system
Regulations for the Supervision and
Administration of Medical Devices
ORDER NO.10\15\16
provision\lists
Regulation
Order
Normative
Document
Guidances
12
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
13
order name
Regulation of
medical device Date of
Implement
NO.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
14 10-13
2000-
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
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•
Medical Device
The State shallClassification
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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起搏导线
翼状头激素电极导线
螺旋头电极导线
Screw-In Tip
美敦力(中国)有限公司 33
2010-5-18
美敦力(中国)有限公司 37
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).
•
20
6801
Basic surgery device
6802
Micro-surgery device
6803
Neurosurgery device
。。。
。。。。。。
The Category of Medical Device
6821
Electrical medical device
Classification
6822
Optical and endscope
www.sfda.gov.cn
6823
Ultrasound medical device
6824
Laser medical device
。。。
。。。。。。
6832
High energy ray equipment
6840
IVD system
Annex
6841
Medical laboratory device
The Category of Medical Device
Classification
6858
Medical cooling therapy and
storage equipment
6863
Dental material
。。。
。。。。
6870
Medical software
6877
Implant device
[2002]NO.302
2002-09-05release
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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.
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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
－ total 9 chapters,56
Articles,12 Annexs.
－ 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
24 to understand.
Registration process
R&D
Clinical
trail
Quality
system
audit
RPS
Type
Collection
testing
materials
Facili
ty
Enterprise
License
Registratio
n
25
Standards of china MD
－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.
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Standardized technical committee
There are 22 standardized technical committees being
response for drafting and revising national and industrial
standards
number
name
secretari
at
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
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”
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Structure of RPS
1.
2.
Scope
Normative references
3.
4.
5.
Classification and composition
requirement
Method of testing
6.
7.
rule of testing
labeling、symbol and
instruction
8.
packing、transportation and
storage
RPS explanation
9.
•thanks！
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