“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, Technical Manager...
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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
description
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.
Transcript of “CFDA Registration – Market Access Before Investment” delivered by Tim Lin, Technical Manager...
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
Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you
Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you
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
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.
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.
Criteria for Device Classification
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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
1Device for Transporation and
Storage of Pharmaceutical Liquid2 2 3 2 2 3 2 3 3
2Device 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
8Device 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 UseForm of Operation
Active, Contacting Device
9
1Device 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
Act
ive
De
vice
2
2
2
2
2
3
3
2
Form of OperationTemporary
Use
Short Term
Use
Long Term
Use
2
2
3
3
Non-Contacting Device
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1 Device for Patient Care
2 In Vitro Diagnostic Reagent
3Other Supplementary
Device
1 Device for Laboratory Use
2 Device for Sterilization
3Other Supplementary
Device
NA
1 2 NA
1 2 NA
Act
ive
De
vice
Form of Operation No Impact Indirect Impact Major Impact
1 2
2 3
1 2 NANo
n A
ctiv
e D
evi
ce Form of Operation No Impact Indirect Impact Major Impact
1 2 NA
1
Key Registration Component
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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
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
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）
Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you
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.
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
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
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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
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
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YY/T 0196-2005
－ Disposable ECG electrodes
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
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
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
Software Requirements
April 28th 2012
Need to provide additional Software Document.
Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL can do for you
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.
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
Software Requirements
April 28th 2012
Need to provide additional Software Document.
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.
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.
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）
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）
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
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
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.
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)
Agenda
1. Overview of CFDA Registration
2. Key Registration Hurdles
3. Latest Regulatory Update
4. What UL provides
Now you are facing,
Search legal / after-sale agent first, then
initiate product registration.
Delay Registration
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
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.
Now you are facing,
Do not know how to write YZB
Delay Registration
UL provides,
Professional Local Expert
To write YZB based on your product
Established product category documentation
Delay Registration
Now you are facing,
Do not know how to write
Software Documents
Delay Registration
UL provides,
Professional Local Expert
To write software requirement document based
on your software documents
Delay Registration
Your Benefit
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• 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.
