1

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

4

5

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

6

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.

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

12

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

13

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

14

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

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

16

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

21

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

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.

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 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

24

－ 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

25

2626

－ 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

8 …… …… ……

There are 22 standardized technical committees being response for drafting and revising national and industrial standards

2828

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 ！

30