In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.

1. 瑞旭集团（CIRS）-北京西尔思科技有限公司
www.cirs-group.com/md
专注于医疗器械技术服务
注册｜临床｜体系｜合规
Overview and Update of Chinese
Medical Device Regulation
CIRS Group｜Medical Device BU
Yo l a n d a md@cirs-group.com
2019.12.05
Wechat：CIRS-MD

2. CONTENTS
 Overview of China’s Medical Device Management
 The Latest Update of China’s Medical Device Regulation
 Implementation Progress of UDI in China
 Overview of China’s Medical Device Registration Electronic Declaration
Information System (eRPS)
 Amendments of Medical Device Supervision and Administration
Regulations
 Brief Analysis of MAH System of Medical Device Industry in China
 Practical Advice on How to Register a Medical Device in China

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Overview of China’s Medical Device
Management

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Chinese Medical Device Market
In 2018, China's health expenditure was $777 billion and accounted for 5.7% of China’s GDP,
which is a far lower percentage than countries like the U.S. (17%), Germany (11%), Canada
(10%), and Japan (10%). Health expenditure, as a percentage of GDP, is expected to increase
to between 6.5-7% by 2020.
Globally, the medical device market is approximately 42% of the size of the pharmaceuticals
market. In China, however, the percentage is much lower at approximately 14%.

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China's Medical Device Administrative System

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constit
ution
Legislatio
n
Administrative l
aws and regulat
ions
Regulations
Regulated documents
Local regulations and standards
Administrative Permission Law,
Standardization law, Pharmaceutical
Administration Law, etc.
Medical Device Supervision and
Management Regulations
Medical Device Registration
Management Measures, Medical Device
Production Supervision and
Management Measures
Innovative Medical Device Special
Approval Procedures, registration review
guidelines, etc.
Classification Determination
notices, NMPA Announcements,
Industry Standards, etc.
China's Medical Device Regulatory System

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Classification Management System
Classification Class I Class II Class III
Registration
Procedure
Put on record/ Filing Registration Registration
Production
Procedure
Put on record/ Filing Production Permit Production Permit
Business Procedure N/A Put on record/ Filing Business Permit
The Class I is the medical device that is low-risk and requires routine management to
ensure its safety and effectiveness.
The Class II is the medical device that is moderate-risk and requires strict control and
management to ensure their safety and effectiveness.
The Class III is the medical device that is high-risk and require special measures to
strictly control management to ensure their safety and effectiveness.
To evaluate the degree of risk of medical devices, factors such as the intended purpose,
structural characteristics, and methods of use of medical devices should be considered.

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Registration Process
Is this a
medical device
product?
No
Yes
Other requirements
Apply for product
classification
determination
Registration Testing
Submit materials;
Administrative
review
Technical review,
Administrative
review
Clinical trials
Prepare required
materials
Able to
determine the
product category?
Registration
certificate
Supplement
missing materials
Supplement missing
materials ,resubmit
the application
QMS audit
Recording
certificate
Are the
materials
complete?
Is the product
exempted for
the clinical trials?
No
Yes
Yes
No
Yes
No
Do you have
agent in China?
No Find a Chinese
agentYes
Class I Class II, III

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The Latest Update of Medical Device
Regulation in China

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The Ministry of Justice issued the "Amendments of Medical Device
Supervision and Administration Regulations (Draft for Review)“
Notice of the NMPA on the Revised Project Plan for the 2019 Medical
Device Industry Standard
Notice on Application for Collection of Digital Certificate (CA) for
Medical Device Registration Electronic Declaration Information System
the NMPA issued the "Notice on Expanding the Pilot Work of Medical
Device MAH System" ([2019] No. 33)
"Medical Device Unique Identification System Rules" officially released;
Interpretation of "Medical Device Unique Identification System Rules"
Notice of the NMPA on issuing specifications for medical device
inspection
Notice on the Submission of Electronic Registration of Medical Device
Registration and Prohibition of Repeated Submission (No. 15 of 2019)
2018.06.25
2019.03.20
2019.05.07
2019.08.01
2019.08.27
2019.09.05
2019.10.14

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Implementation Progress of Medical
Device Unique Identification (UDI) in
China

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Unique Device Identification (UDI)
Unique Device Identification (UDI) refers to a code consisting of
numbers, letters, or symbols attached to a medical device product
or package, and is used to uniquely identify a medical device.
Unique medical device identification includes: Device Identification
(DI) and Production Identification (PI).

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Unique Device Identification (UDI) System
Medical
Device
UDI
System
Medical Device Unique Device
Identification
UDI Carrier
UDI Database

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Declaration Process of DI
Choose a code issuing
agency
The medical device registrant / filer chooses a qualified
code issuing agency.
Start coding
The code issuing agency provides the code segment
and corresponding coding rules to the registrant / filer ,
and guides the coding work.
Registration
declaration
Newly registered products need to report DI in the
registration system.
Encode the devices The registrant / filer assigns a code to the product,
giving it a unique identification.
Identification
declaration
After the product code is completed, log in to the
NMPA ’s medical devices UDI management information
system and carry out work related to the UDI
declaration of the product.

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Pilot Schedule of UDI
Time Plan
2019.07
Identify pilot varieties and participating units. Establish a collaborative working
group for the pilot work department of the UDI and issue a pilot work plan.
Organize pilot training and start pilot work. The pilot unit shall formulate
implementation plans, refine the task measures, and clarify the acceptance
indicators.
2019.08—11
Organize the verification work of creation and assignment of UDI for medical
devices.
2019.12—2020.02
Organize the verification work of upload, download and interface standards
for medical device’s UDI databases
2020.03—06
Organize the verification work of Inter-departmental connectivity and
extension applications of UDI data
2020.07
Organize a pilot summary meeting to form a pilot report and improve the UDI
implementation plan for the first batch of products.

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The Completed Pilot Work
Time Completed work
2019-07-03 Issued a pilot work plan and started pilot work.
2019-08-09 Organized pilot training and Identified participating units.
2019-08-27
Established a collaborative working group for the pilot work
department of the UDI.
2019-10-15 Identified pilot varieties

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Overview of Medical Device
Registration Electronic Declaration
Information System (eRPS)

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eRPS System
The eRPS system displays the current medical device registration application
requirements in China in the form of a directory listing (ToC) of the International
Medical Device Regulatory Agency Forum’s (IMDRF) Registration Declaration
Specification (RPS) project.
Key Benefits
-Convenient for registered
applicants to submit
registration documents
-Save review approval
time and standardize
registration process
-Complete and clear
catalog of required
materials
-Adopt CA(Certification
Authority) to improve data
security level

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Certification Authority (CA) Certificate
The CA certificate is provided by the nationally approved electronic
certification service agency, with USB KEY as the medium, as an identity
verification certificate and electronic signature tool for applicants to log in and
upload electronic filing materials.

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Scope of Application
 Registration of domestic Class III medical devices / IVD reagents
 Registration of imported Class II and III medical devices / IVD reagents
 Continuation registration of domestic / imported medical devices / IVD
reagents
 Alteration registration of domestic / imported medical devices / IVD reagents
 Clinical trial approval domestic / imported medical device / IVD reagents
 Special review of innovative medical devices
 Notification of alterations to medical device instructions
 Correction of alteration document of medical device / IVD reagent
registration certificate
 Review of medical device / IVD reagents registration / license alteration

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Directory Structure

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Release Time Standards and Regulations
2019-05-07
Notice on Application for Collection of Digital Certificate (CA) for Medical Device
Registration Electronic Declaration Information System
2019-05-31
Announcement on Implementing Electronic Declaration of Medical Device
Registration (No. 46 of 2019);
Notice on the Technical Guidelines for Electronic Declaration of Medical Device
Registration Applications (No. 29 of 2019)
2019-06-06
Notice on Relevant Issues Concerning the Handling of Medical Device Registration
Electronic Declaration Information System Business (No. 4 of 2019);
Notice on the Structure of the Electronic Filing Directory Folder of the Medical
Device Registration Electronic Declaration Information System (No. 5 of 2019)
2019-07-10
Notice on the Relevant Material Requirements for Electronic Declaration of Medical
Devices (No. 41 of 2019);
Notice of the "Medical Device Product Registration Project Filing Review
Requirements (Trial)" (No. 42 of 2019)
2019-10-14
Notice on the Submission of Electronic Registration of Medical Device Registration
and Prohibition of Repeated Submission (No. 15 of 2019)

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Implementation Date of eRPS System
Since May 10, 2019, medical device registration applicants could apply for the Digital
Certificate (CA) for the eRPS system.
On June 24, 2019, the eRPS system was officially launched. At the same time, the
NMPA maintains the submission of paper materials.
From November 1, 2019, the submission of paper materials shall be in accordance
with the requirements of the "Technical Guide for Electronic Submission of Medical
Device Registration Applications (Trial)", which is consistent with the form of the
electronic filing catalog

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Declaration Process in eRPS System

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Amendments of Medical Device
Supervision and Administration
Regulations

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Brief Introduction
On June 25th, 2018, the government website of the Ministry of Justice issued a public
consultation notice on the "Amendment of Medical Device Supervision and
Management Regulations (Draft for Review)".

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There were 53 amendments in this revised draft: adding 12 articles, deleting 2
articles and modifying 39 articles. Among them, the main changes are as follows:
1. Improve the MAH system
2. Increase the regulations on the management of Chinese agents of overseas
registration certificate holders
3. Reform the clinical trial management system
4. Optimize the review and approval procedures and recover the approval
authority for the registration and review of the Class II medical device products
5. Some Class II medical equipment can be operated without filing

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6. Clearly prohibit the import and sale of used medical devices
7. Cancel the approval of medical device advertisements
8. Increase the concept of counterfeit medical devices
9. Clarify the supervision and inspection of the National, the provincial and
the municipal medical products administration, and increase the regulatory
measures.
10. Improve the re-inspection system
11. Add specific provisions for penalties to people
12. Increase the penalty amount for intentional violations

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Brief Analysis of MAH System of
Medical Device Inndustry in China

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Brief Introduction
Medical
Device
Registration
Certificate
Production
License
Quality
Assurance
Marketing
Authorization

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MAH System
What is the Marketing Authorization Holder (MAH)?
The holder of the marketing authorization is the person who applies for the
registration the medical device, and has filed with the local Medical Product
Administration or approved by the NMPA, and obtained the medical device
registration certificate.
1. Establish a quality management system that is compatible
with the product and maintain effective operation;
2. Develop a continuous research and risk management plan
after listing and ensure its effective implementation;
3. Carry out adverse event monitoring work according to law
and re-evaluation work;
4. Establish and implement a product traceability and recall
system;
5. Other obligations as stipulated by the drug regulatory
department of the State Council.
What are the obligations of Marketing Authorization Holder?

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Basic conditions for Production Company (Trustee)
1. The production address of the enterprise is located in the pilot provinces, autonomous
regions and municipalities.
2. Possess a quality management system and production capacity that are compatible with
the production of medical device entrusted.
3. Encouraged to have the YY0287 / ISO13485 certification.
MAH System
Basic conditions for Marketing Authorization Holder
1. The residence or production address of the enterprise or scientific research institution is
located in the pilot provinces, autonomous regions and municipalities.
2. Full-time technical and management personnel related to regulatory affairs, quality
management, post-marketing affairs, etc., with relevant knowledge and experience.
3.Establish a QMS that is compatible with the product and maintain effective operation, and
have staff who independently evaluate, review and supervise the QMS.
4.Ability to take responsibility for quality and safety of medical devices

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Three Parties in MAH System
Client
• Screening of Entrusted
Companies
• Quality audit and quality
agreement
• R & D and production
conversion
• Annual quality review
• Production release and
market release standards
• Re-evaluation mechanism
and after-sales service
• Quality traceability system
Trustee
• Fulfilling regulatory
requirements
• GMP compliance
• Meet the agreed
content of the quality
agreement
• Production of samples
and products
• Production quality
control
• Reporting mechanism
Supervisor
• Assess the contract
and quality agreement
between the two parties
• Assess the client's
quality management
capabilities
• Assess trustee
qualifications and
capabilities
• On-site inspection and
post-market supervision

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MAH SYSTEM CURRENT SYSTEM
Applicant for
Registration
Enterprises and research institutions in
the 21 pilot provinces and cities Medical device manufacturer
Product Launch
Mode
The registrant could entrust a third party
to develop, produce, sell and compliance
audit; the registrant could only hold the
medical device registration certificate;
and it is allowed to commission a number
of production enterprises to produce.
The registrant shall hold both the
medical device registration certificate
and the production license, and the
enterprise that accepts the
commissioned production shall also
hold the corresponding registration
certificate and production license.
The Relevant Party of
the Marketing
Authorization
Marketing authorization holder (the
trustor); medical device research and
development institution or production
organization (the trustee); regulator
Medical device manufacturer; regulator
Comparison

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Implementation of MAH System
Release Time Standards and Regulations
2017-10-08
The State Council issued the Opinions on Deepening the Reform of the Review
and Approval System and Encouraging the Innovation of Drugs and Medical
Devices
2017-12-07
Shanghai took the lead in launching the pilot work and released the pilot
scheme of the medical device registrant system.
2018-05-24
Guangdong and Tianjin announced plans to deepen the reform of the free trade
zone, and the pilot work of the medical MAH system was extended to
Guangdong and Tianjin.
2018-06-25
The Ministry of Justice issued the "Amendments of Medical Device Supervision
and Administration Regulations
(Draft for Review)", which officially incorporated the medical device MAH
system into the regulations
2019-08-01
the NMPA issued the "Notice on Expanding the Pilot Work of MAH System"
([2019] No. 33)

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Compliance Process of MAH System

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Practical Advice on How To Register a
Medical Device in China

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Is this a
medical device
product?
Registration Testing
Clinical trials
Able to
determine the
product category?
Is the product
exempted for
the clinical trials?
Do you have
agent in China?
- Medical devices should be listed in the country of origin.
- Determine the corresponding product classification
according to Catalog/ apply for the classification
determination.
- Find a Chinese agent/ establish a Chinese subsidiary
- Change of agent does not require signature of original agent
- For Biological test, overseas GLP report can be used, with
the laboratory qualification certificate.
- In the catalog of medical devices exempted from clinical
trials
- Analytical evaluation by data obtained from clinical trials or
clinical application of medical devices of the same variety
- Clinical evaluation with overseas clinical data
- Clinical trials

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Technical review,
Administrative
review
Registration
certificate
QMS audit
- For Quality Management System, GMP certification is
required, and there will be QMS verification during the
registration process
- Keep the original registration certificate
- Keep the materials of the first registration
- The change or renewal of the registration certificate
needs to be applied at least six months before its
expiration.
- Gap analysis before production

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爱尔兰子公司
瑞旭集团(中国)
北京西尔思
关于瑞旭集团（CIRS）
 CIRS是一家全球领先的产品安全管理咨询服务机构，总部
位于中国杭州，在都柏林(爱尔兰)，美国，韩国、北京，
南京，杭州设有分支机构。CIRS成立于2007年，目前拥
有200+员工，年营业额大约30,000,000 USD。
 CIRS提供产品法规合规咨询，检测认证以及培训服务
 瑞旭集团医疗器械事业部专业提供中国医疗器械注册申
报、临床试验、质量体系等“一站式”合规咨询服务。
 全球客户超过4000家。
美国子公司
CIRS中国 (总部)
Email: md@cirs-group.com
地址:杭州市滨江区秋溢路288号东冠高新科技园1号楼11层
电话: +86 571 8720 6555 传真: +86 571 8720 6533
CIRS 北京-北京西尔思科技有限公司
Email: md@cirs-group.com
电话: +86 10 63984062
地址: 北京市西城区宣武门西大街288号大成广场7门1109-1111室
CIRS欧洲
地址: CIRS, Regus Harcourt Centre D02 HW77, Dublin, Ireland
CIRS美国
地址：#200-092, 3100 Clarendon Blvd., Arlington, VA 22201
CIRS韩国
地址：B-2310, 583, Yangcheon-ro, Gangseo-gu, Seoul, Republic
of Korea
韩国子公司
希科检测
南京瑞旭

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Medical Devices Clinical Evaluation
- Clinical Trials for Medical Devices
and IVD
- Pre-Clinical Investigation of
Medical Devices
- Clinical Trial Protocol Design for
Medical Devices
- Clinical Trials Auditing and Quality
Assurance
- Data Management and Statistical
Analysis
- Draft Clinical Trial Report and
Clinical Evaluation Report
- Medical Device Clinical Monitoring
Medical Devices Registration
- Regulatory Compliance Assessment
an Registration Consulting
- Product Classification, Attributes
Define and Registration Proposal
Confirmed
- Registration (Recording) for
Medical Devices and IVD
- Registration Certificate Update and
Renewal for Medical Devices and IVD
- Coordinate the Registration
Inspection and Commissioned
Inspection
- Compilation and Submission of
Technical Construction File
Medical Devices Quality
Management System Service
- Initial Analysis and
Confirmation when QMS
Establishing
- QMS Designing and Consulting
- QMS Establishment and
Operation Consultation
- Training of QMS and QMS Self-
inspection
- QMS on-site Audit and
Correction Consultation
- ISO 13485 QMS Establishment
and Consultation
What Can We Offer

42. Thank You!
Web： www.cirs-md.com (EN)
Tel：0571-8720 6541
Mail：md@cirs-group.com
CIRS-MD