Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles. The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process. Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry. This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.

1. UL and the UL logo are trademarks of UL LLC © 2013
CFDA Registration
– Market Access Before Investment
Tim Lin
Technical Manager
UL MDRS, AP Region
Delivered June 26, 2013 by Webinar

2. Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you

3. Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you

4. Definition of Medical Device
It refers to those instruments, apparatus, appliances, materials and other objects,
including the software attached to them, that are designed to be used either
independently or in combination on human body. These devices are used for:
 Diagnosis, prevention, monitoring, treatment or
alleviation of disease;
 Diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap conditions
 Investigation, replacement or modification for anatomy
or a physiological process;
 Control of conception.
Basically, the effect of these devices on human body is not
achieved through means of pharmacology, immunology or
metabolism; though they might be resorted to in order to
bring about certain supplementary effect.
Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html

5. Basic Regulatory Structure
1. 3 classifications based on risk
2. Similar to CE Mark and FDA, the classification
determines registration route.
3. Used for human. Animal use is not included.

6. Device Classification
 Class I: Under routine administration for their safety and
efficacy,
Ex: Rehabilitation techniques, disinfecting devices and
apparatus.
 Class II: Controlled for their safety and efficacy,
Ex: Weak laser in-vitro treatment instruments.
 Class III: Implanted into the human body, or used for life
support or sustenance, and pose potential risk to human life,
Ex: Implanted artificial internal organs and infant care devices.

7. Criteria for Device Classification
7

8. Non Active, Contacting Device
8
Skin/
Cavity & Tract
Trauma/
Tissue
Circulation;
Blood/Central
Skin/
Cavity & Tract
Trauma/
Tissue
Circulation;
Blood/Central
Skin/
Cavity & Tract
Trauma/
Tissue
Circulation;
Blood/Central
1
Device for Transporation and
Storage of Pharmaceutical Liquid
2 2 3 2 2 3 2 3 3
2
Device for alternation of blood and
body fluids NA NA 3 NA NA 3 NA NA 3
3 Device for medical dressing 1 2 2 1 2 2 NA NA NA
4 Surgical instruments (inserted) 1 2 3 2 2 3 2 3 3
5 Reusable surgical instruments 1 1 2 NA NA NA NA NA NA
6 Disposible aspetic surgical device 1 2 3 2 3 3 2 3 3
7 Implantables NA NA NA NA NA NA 3 3 3
8
Device for contraception and birth
control 2 2 3 2 3 3 3 3 3
9 Device for sterilization and cleaning 2 2 2 2 2 2 2 2 2
10 Other Non Active Devices 1 2 3 2 2 3 2 3 3
Temporary Use Short Term Use Long Term Use
Form of Operation

9. Active, Contacting Device
9
1
Device of treatment with energy
source
2 Device for diagnostic monitoring
3 Device for body fluid transportation
4 Device with ionizing radiation
5 Other general active device
3
3
NA
ActiveDevice
2
2
2
2
2
3
3
2
Form of Operation
Temporary
Use
Short Term
Use
Long Term
Use
2
2
3
3

10. Non-Contacting Device
10
1 Device for Patient Care
2 In Vitro Diagnostic Reagent
3
Other Supplementary
Device
1 Device for Laboratory Use
2 Device for Sterilization
3
Other Supplementary
Device
NA
1 2 NA
1 2 NA
ActiveDevice
Form of Operation No Impact Indirect Impact Major Impact
1 2
2 3
1 2 NA
NonActiveDevice
Form of Operation No Impact Indirect Impact Major Impact
1 2 NA
1

12. Key Registration Component
12

13. Required Document
1. Application form for registration of import medical device
2. Legal Qualification certification for medical device manufacturing
enterprise.
3. A Copy of applicant’s business license and proxy for registration
entrusted by the Manufacturing enterprise
4. Marketing approval from country of origin or device is accepted by
medical device competent authority.
5. Applicable product standard and instructions
6. User’s manual / Operation Manual

14. Required Document (cont’d)
7. Test report on product registration given by medical device
inspection institutions (applicable to Class II and Class III medical
device)
8. Clinical Trial Report, if required
9. Product Quality Guaranty by Manufacturer
10. Business License & Commitment Letter of local legal agent, the
original entrust letter from manufacturer
11. Business License & Commitment Letter of local after sales agent
and the original entrust letter from manufacturer
12. Self Declaration letter on material authenticity by manufacturers

15. Application Process
Identify Application, Legal
& After-Sales Agent（确认
申请、代理人和售后代理人）
Technical Evaluation
by CMDE（技术审评）
Determine Device
Classification（确认类别）
Formulate Test
Standard（起草产品标准）
File for Testing approval
（取得检验报告）
Determine Clinical Evaluation
Path（确定临床方案）
Conduct Clinical Study
(if required)（临床试验）
Prepare Chinese
Documents（申报资料准备）
Final Product Approval
Preview Original
Registration Document（检
查原注册文件）

16. Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you

17. Identify Agent of
Application, Legal and After-Sales
 Registration Agent:
 To coordinate and control CFDA registration
 Qualification: business license
 Legal Agent:
 Report any adverse events that occur inside or outside China to
CFDA
 Handle any recall incidence in China if arises
 Qualification: business license
 After Sales Agent:
 Provide technical service and maintenance support, which must
be included in the business scope of the business license
 Qualification: business license
Agent Contact Person Must be a Chinese Resident.

18. Product Standard : YZB
 Manufacturer should create a YZB as one component of
registration dossier.
 YZB includes performance and safety items
 If there is relevant GB/YY, manufacturer can adopt them (700
standards)
 If no relevant GB/YY, or manufacturer is not willing to adapt
Chinese standards, manufacturer should compile a product
standard. (In latter case, parameters should be superior to superior to GB/YY)
 Must be in Chinese

19. Standards - Patient monitor
GB9706.1-2007 IEC60601－1：1988
A1：1991+A2：1995
Medical electrical equipment—Part 1:General
requirements for safety
YY 0505-2012 IEC 60601-1-2:20xx Medical electrical equipment—Part 1-2:General
requirements for safety—Collateral standard:
Electromagnetic compatibility—Requirements and
tests
19
GB/T16886.1-
2011
ISO 10993-1:2009 Biological evaluation of medical devices—Part
1:Evaluation and testing within a risk management
process
GB/T 191-2008 ISO 780:1997 Packaging—Pictorial marking for handling of goods
GB/T14710-
2009
－ Environmental requirement and test methods for
medical electrical equipment
局令第10号 － Administrative Regulation of Medical Device
Specification, Label and Packaging Identification

20. Standards - Patient monitor
GB9706.25-2005 IEC60601-2-27:1994 《医用电气设备 第2-27部分：心电监护设备安全专用要求》
Medical electrical equipment—Part 2:Particular requirements for
the safety of electrocardiographic monitoring equipment
YY0667-2008 IEC60601-2-30:1999 Medical electrical equipment—Part 2-30:Particular requirements
for the safety, including essential performance, of automatic
cycling non-invasive blood pressure monitoring equipment
YY0668-2008 IEC60601-2-49:2001 《医用电气设备 第2部分：多参数患者监护设备安全专用要求》
Medical electrical equipment—Part 2-49:Particular requirements
for the safety of multifunction patient monitoring equipment
YY 0709-2008 IEC 60601-1-8:2003 Medical electrical equipment—Part 1-8:General requirements for
safety—Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and
medical electrical systems
YY 1079-2008 － 《心电监护仪》
Electrocardiographic monitors
YY 0670-2008 － 无创自动血压计
Non-invasive automated sphygmomanometer
20
YY/T 0196-2005 － Disposable ECG electrodes

21. Testing Approval (Actual testing)
 Mandatory to test the product at a CFDA accredited
center
 Obtain test report before regulatory submission is
required.
 Type Test Report should be within past 12 months
 Usually testing report restrict the submitting time

22. Clinical Evaluation
 Clinical Evaluation documents for registration in the country of
origin;
 If there is no clinical trial report from the country of origin,
manufacturer should provide the evidence (rule, regulation, etc),
and also provide clinical information after selling
 If the manufacturer of a Class III implant product is the 1st time
entry of China market, it is required to conduct a clinical study in
China.
New Announcement: Clinical evaluation report of some class II items
can be instead of comparison result with similar product
Must be in Chinese

23. User’s Manual
 Based on the Manual of original
 GB/T 9969-2008 General principles for instructions
for use
 10th Administrative Order: Administrative Regulation
of Medical Device Specification, Label and
Packaging Identification
Must be in Chinese

24. Software Requirements
April 28th 2012
 Need to provide additional Software Document.

25. Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you

26. CCC mark
2013 Announcement No.52
In the past, 8 medical device need to additionally tested
for CCC (China Compulsory Certification) mark.
 Medical X-ray diagnostic equipment,
 Hemodialysis equipment,
 Hollow fiber dialyzers,
 Extracorporeal blood circuit for blood purification equipment,
 Artificial heart-lung machines,
 ECGs,
 Implantable cardiac pacemakers
 Rubber condoms.
No need any more since May 2 2013.

27. Administration Level Change - CFDA
March 22nd 2013
1. SFDA has elevated to Ministerial department (From
vice-ministerial), its name also changed to “CFDA”.
2. Independent medical device registration
department
3. The previous regulation/policy is still valid.
http://www.sfda.gov.cn/WS01/CL0051/79254.html

28. Software Requirements
April 28th 2012
 Need to provide additional Software Document.

29. Software Requirements
April 28th 2012
 Software type:
 Independent software: Software as medical device or
accessory, such as processing software, data software.
 Software component: Software as component of medical
device, part or accessory, such as embedded software,
control software.
 Specialized software: such as individual customer-made
software.

30. Software Requirements
April 28th 2012 (cont’d)
 Risk Classification of Software
Class A: No injury or damage to health is possible
Class B: Non-SERIOUS INJURY is possible
Class C: Death or SERIOUS INJURY is possible
 Quantity and level of detail depends on software risk
classification.

31. Software Requirements - Contents
April 28th 2012 (cont’d)
1. Basic Information （基本信息）
1.1 Product Identification （产品标识）
1.2 Safety Class （安全性类别）
1.3 Architecture Function （结构功能）
1.4 Hardware Relationship（硬件关系）
1.5 Operation Environment （运行环境）
1.6 Indications （适用范围）
1.7 Contraindications （禁忌症）
1.8 Listing History （上市历史）

32. Software Requirements - Contents
April 28th 2012 (cont’d)
2. Development Process （实现过程）
2.1 Development Review （开发综述）
2.2 Risk Management （风险管理）
2.3 Requirement Specification （需求规格）
2.4 Lifecycle （生存周期）
2.5 Verification and Validation （验证与确认）
2.6 Defect Management （缺陷管理）
2.7 Revision History （修订历史）
2.8 Clinical Evaluation （临床评价）
3. Core Algorithm （核心算法）

33. Some Class II Devices are Exempted From
Clinical Evaluation Data (国食药监械[2011]475号)
 A list of these devices exempted from clinical
evaluation data
 Document of comparison results shall be
provided

34. EMC Requirements
国食药监械[2012]151号
 YY0505-2012 医用电气设备 第1-2部分：安全通用要求并列标准： 电
电磁兼容要求和试验
(Harmonized to IEC60601-1-2 : 2004: Medical electrical
equipment—Part 1-2:General requirements for safety—Collateral
standard: Electromagnetic compatibility—Requirements and tests)
 The date of taking effect (submit EMC report)
 Class III Device : 1st Jan 2014
 Class II Device : 1st Jan 2015

35. Label & package marks
国食药监械[2012]280号
 It must include Chinese label/package marks, other
language is allowed.
 The procedure of producing Chinese Label/package
marks must be included in production of device,
under manufacture quality system control.
 It is no more allowed to paste the labeling by agent
after device is shipped to China.

36. Factors influence approval time
 Quality of the documentations
 Writing YZB and Software Documents
 Time frame of actual testing
 Re-work
 Language Barrier (All documents must be in Chinese)

38. Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL provides

39. Now you are facing,
Search legal / after-sale agent first, then
initiate product registration.
 Delay Registration

40. UL provides,
Legal / After-sales agents
To let you start product registration ASAP
To let you search your partner when registration is
in-process
You can transfer license to your legal / after sale
partner after getting product license, Delay Registration

41. Testing
Draft
Product Standard Assembly Dossier
CFDA Assessment
Registration
Search for distributor
6 ~ 8 months 4 ~ 6 months Start selling right after
finding distributor
Introducing Product Agent for CFDA Registration
Introducing After-Sale Agent for CFDA Registration
More benefit to customer:
• UL has partners for business matching ability to help customer for finding the
right business partner.
• UL can help customer understand the market characters.

42. Now you are facing,
Do not know how to write YZB
 Delay Registration

43. UL provides,
Professional Local Expert
To write YZB based on your product
Established product category documentation
 Delay Registration

44. Now you are facing,
Do not know how to write
Software Documents
 Delay Registration

45. UL provides,
Professional Local Expert
To write software requirement document based
on your software documents
 Delay Registration

46. Your Benefit
46
• Start the CFDA Regulation work at anytime before any investment in
China.
• Early entry ticket;
− Allowing manufacturer to research the market with less pressure for
better decision.
− Allowing manufacturer has better bargain power for selecting good
business partner.
• Minimize the cultural impact as UL has a good understanding of the US
regulation, CE MDD Regulation and China regulation which is able to lead
customer get into the right direction of registration work in China.
• Trusted Partner in China for searching business partner.

47. Thank you
Contact Information:
Medical.Inquiry@ul.com