China FDA Medical Device RegistrationMedical Device RegistrationIntroductionCFDA중국의료기기허가CFDA 중국의료기기허가

Tim LinSenior Technical Manager

Medical Regulatory Advisory ServiceMedical Regulatory Advisory ServiceHealth Sciences, UL

UL and the UL logo are trademarks of UL LLC © 2013

Important Indicator 주요지시자

Population: > 1.3 bn. 인구 13억

Official written language: Chinese (Simplified) 공용어: 중국

Birth rate: 12.25 births/1,000 ppl. 출생률 1000명당 12.15명

Life Expectancy: 74.99 yr. 수명 74.99년

Health Expenditure: 5.1% of GDP 건강비용 GDP의 5.1%

GDP per capita (PPP): 9,300 USD 인당 GDP: $9,300

/ 병원침대밀도 명당Hospital bed density: 4.2 beds/1,000 ppl.병원침대밀도 1000명당 4.2

침대

Agenda 목차

1 Overview of CFDA Registration CFDA규정의1. Overview of CFDA Registration CFDA 규정의개요

2 Key Registration Hurdles허가시주요고충사항2. Key Registration Hurdles 허가시주요고충사항3. Latest Regulatory Update 최근규정갱신4 C St di d Ti 사례연구및팁4. Case Studies and Tips 사례연구및팁

Agenda 목차

1. Overview of CFDA Registration CFDA 규정의개요개요

2. Key Registration Hurdles 허가시주요고충사항3 Latest Regulatory Update최근규정갱신3. Latest Regulatory Update 최근규정갱신4. Case Studies and Tips 사례연구및팁

Administration Level of CFDA

……

State Forestry Administration Food

State Administration of Work Safety

State Administration for Religious Affairs

State Forestry Administration Food

Health FoodState Administration of Work Safety

The State Council China Food and Drug Administration

National Bureau of Statistics

Medical Device

National Bureau of Statistics

National Tourism Administration

National Bureau of Corruption Prevention Cosmetics

Drug

……National Bureau of Corruption Prevention Cosmetics

Definition of Medical Device 의료기기의정의

It refers to those instruments, apparatus, appliances, materials and other objects,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: 다음과같은목적으로인체에적용하기위해단독혹은조합으로사용되는모든계기, 장치, 장비 재료및기타품목 (부착된소프트웨어를포함)장비 ,재료및기타품목 (부착된소프트웨어를포함):

Diagnosis, prevention, monitoring, treatment or alleviation of disease; 질병의진단, 예방, 감시, 치료혹은경감Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions 상해나장애상태의진단, 감시, 치료, 경감혹은보수Investigation, replacement or modification for anatomy or a physiological process; 해부학적인혹은생리학적프로세스의검사 교체혹은수정해부학적인혹은생리학적프로세스의검사, 교체혹은수정Control of conception. 임신중절

Basically, the effect of these devices on human body is not achieved through means of h l i l t b li th h th i ht b t d t i dpharmacology, immunology or metabolism; though they might be resorted to in order

to bring about certain supplementary effect. 또한,약리학적, 면역학적혹은신진대사에관한방법에의해인체에서의주요용도를달성할수없으나그방법들에의한기능상의보조를받을수있는기기보조를받을수있는기기

Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html

Basic Regulatory Structure 기본규제골격

위험에기 한 분1. 3 classifications based on risk 위험에기초한 3등급분류

2 Similar to CE Mark and FDA the classification2. Similar to CE Mark and FDA, the classification determines registration route. 허가방법이결정되는분류도 CE마크나 FDA와유사하다.

3. Used for human. Animal use is not included. 인체에적용하는기기에대한것이며동물용은포함되지않는다적용하는기기에대한것이며동물용은포함되지않는다.

Device Classification 기기의등급분류

Cl I U d ti d i i t ti f th i f t d ffiClass I: Under routine administration for their safety and efficacy, Ex: Rehabilitation techniques, disinfecting devices and apparatus.

1등급: 일반적인안전성및유효성관리

Class II: Controlled for their safety and efficacy, Ex: Weak laser in vitro treatment instrumentsEx: Weak laser in-vitro treatment instruments.

2등급: 안전성및유효성관리

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. p g

3등급: 인체내에이식되는기기혹은생명유지혹은생명보조및인간의수명에잠재적인위험이있는기기

Criteria for Device Classification 분류기준

9

Non Active, Contacting Device 비능동, 접촉기기

Skin/Cavity & Tract

Trauma/Tissue

Circulation;Blood/Central

Skin/Cavity & Tract

Trauma/Tissue

Circulation;Blood/Central

Skin/Cavity & Tract

Trauma/Tissue

Circulation;Blood/Central

Temporary Use Short Term Use Long Term UseForm of Operation

1Device for Transporation and Storage of Pharmaceutical Liquid 2 2 3 2 2 3 2 3 3

2Device for alternation of blood and body fluids NA NA 3 NA NA 3 NA NA 3y

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 36 Disposible aspetic surgical device 1 2 3 2 3 3 2 3 3

7 Implantables NA NA NA NA NA NA 3 3 3

Device for contraception and birth 2 2 3 2 3 3 3 3 38Device 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 3 310

Active, Contacting Device 능동접촉기기

Temporary Short Term Long Term

1 Device of treatment with energy e 2

Form of OperationTemporary 

UseShort Term 

UseLong Term 

Use2 31

source

2 Device for diagnostic monitoringDev

ice 2

2

2

2

3

3

3 Device for body fluid transportation

4 Device with ionizing radiation

3

3Activ

e  2

2

3

34 Device with ionizing radiation

5 Other general active device

3

NA

A 2

2

3

2

11

Registration Difference between Domestic MD d I t d MDand Imported MD

허가시중국내제조의료기기와수입의료기기의차이점차이점

Risk위험 Domestic제조 Imported수입Risk 위험 Domestic 제조 Imported 수입

Class III 3등급 Beijing BeijingClass III 3등급 Beijing Beijing

Class II 2등급 Home Province BeijingClass II 2등급 Home Province Beijing

Class I 1등급 Home City BeijingClass I 1등급 Home City Beijing

http://www.cfda.gov.cn/WS01/CL1026/

Key Registration Component 허가시주요사항

14

Required Documents 요구문서

1. Application form for registration of import medical device 수입의료기기의허가를위한신청서

2. Legal qualification certification for medical device manufacturing enterprise. 의료기기제조회사에대한법적인정

3. A copy of applicant’s business license and proxy for registration entrusted by the Manufacturing enterprise 신청인의사업허가사본및제조회사로위임을받은대리인

4. Marketing approval from country of origin or device is accepted by medical device competent authority.

원산지혹은기타국가에서의허가서류

5. Applicable product standard and instructions 제품규격및사용설명

6. User’s manual / Operation manual 사용자설명서 / 작동매뉴얼

Required Document (cont’d) 요구문서 (계속)

7 T t t d t i t ti i b di l d i i ti i tit ti7. Test report on product registration given by medical device inspection institutions (applicable to Class II and Class III medical device) 의료기기시험기관의시험성적서 (2등급및 3등급의료기기)

8. Clinical Trial Report, if required 필요한경우, 임상시험성적서

9. Product Quality Guaranty by Manufacturer 제조자의품질보증

10. Business License & Commitment Letter of local legal agent, the original entrust letter from manufacturer 법적대리인에관한사업허가및위임장

11. Business License & Commitment Letter of local after sales agent and the original entrust letter from manufacturer 판매대리인에관한사업허가및위임장

12 S lf D l ti l tt t i l th ti it b f t 재질의신뢰성에12. Self Declaration letter on material authenticity by manufacturers 재질의신뢰성에대한자가선언서

Application Process 신청프로세스

Identify Application, Legal & After-Sales Agent（确认申请、代理人和售后代理人）

Determine Device Classification（确认类别）

Preview Original Registration Document（检查原注册文件）申请、代理人和售后代理人）

Formulate Test Determine Clinical Evaluation

（检查原注册文件）

Standard（起草产品标准）

File for Testing approval

Path（确定临床方案）

Conduct Clinical StudyFile for Testing approval（取得检验报告）

Conduct Clinical Study (if required)（临床试验）

Prepare Chinese Documents（申报资料准备）

Technical Evaluation by CMDE（技术审评）

Final Product Approval

Agenda 목차

1. Overview of CFDA Registration CFDA 규정의개요개요

2. Key Registration Hurdles 허가시주요고충사항3 Latest Regulatory Update최근규정갱신3. Latest Regulatory Update 최근규정갱신4. Case Studies and Tips 사례연구및팁

Identify Agent of 대리인구별A li ti L l d Aft S lApplication, Legal and After-Sales 신청, 법적및판매후

허가대리인Registration Agent: 허가대리인To coordinate and control CFDA registrationQualification: business licenseQualification: business license Legal Agent: 법적대리인Report any adverse events that occur inside or outside China to CFDA 부작용보고Handle any recall incidence in China if arises 리콜사고처리Qualification: business licenseQualification: business license After Sales Agent: 판매후대리인Provide technical service and maintenance support, which must be included in the business scope of the business license 기술서비스및제품의유지보수.Qualification: business licenseQualification: business license

Product Standard : YZB 제품규격

M f h ld YZB f i iManufacturer should create a YZB as one component of registration dossier. 제조자는허가서류중하나로 YZB문서를작성해야한다.

YZB includes performance and safety items. YZB는 성능 및 안전항목들을포함한다.

If there is relevant GB/YY, manufacturer can adopt them (700 standards) 중국규격 (700 개정도)If no relevant GB/YY or manufacturer is not willing to adaptIf 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 Chinese중국어로작성해야한다.

Standards - Patient monitorGB9706.1-2007 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 andg p y q

tests

GB/T14710-

2009

－ Environmental requirement and test methods for

di l l t i l i tGB/T16886.1-

2011

ISO 10993-1:2009 Biological evaluation of medical devices—Part

1:Evaluation and testing within a risk management

2009 medical electrical equipment

processGB/T 191-2008 ISO 780:1997 Packaging—Pictorial marking for handling of goods

局令第10号 － Administrative Regulation of Medical Device

Specification, Label and Packaging Identification

21

Standards - Patient monitorGB9706.25-2005 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

YY/T 0196-2005 － Disposable ECG electrodes

22

Testing Approval (Actual testing) 형식시험

M d h d CFDA di dMandatory to test the product at a CFDA accredited center 지정시험소에서제품을시험하는것이강제사항이다.

Obtain test report before regulatory submission is required. 허가서류를제출하기전에시험성적서를확보할것.

Type Test Report should be within past 12 months형식시험성적서는 12개월이내에작성된것이어야한다형식시험성적서는 12개월이내에작성된것이어야한다.

Usually testing report restrict the submitting time 시험성적서때문에제출시기는제한될수있다.

Clinical Evaluation 임상평가

Clinical Evaluation documents for registration in the country of origin; 원산지국가에서의임상평가문서원산지국가에서의임상평가문서

If there is no clinical trial report from the country of origin, manufacturer should provide the evidence (rule regulation etc) and also provideshould provide the evidence (rule, regulation, etc), and also provide clinical information after selling

원산지국가에서임상시험성적서가없는경우, 제조자는기타자료(규칙, 규정등)를제공해야하고판매후임상정보도제공해야한다등)를제공해야하고판매후임상정보도제공해야한다.

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.

3등급이식형제품이중국에처음공급된다면, 중국에서의임상시험이요구된다.

New Announcement: Clinical evaluation report of some class II items can be instead of comparison result with similar product새로운고시:일부 2등급의료기기의임상평가보고서는유사한제품과의동등성새로운고시: 일부 2등급의료기기의임상평가보고서는유사한제품과의동등성비교로대신할수있다. Must be in Chinese

User’s Manual 사용자매뉴얼

원래매 얼에 거해야Based on the Manual of original 원래매뉴얼에근거해야한다.

GB/T 9969-2008 General principles for instructions for use 사용설명서에대한일반원칙. 중국규격

10th Administrative Order: Administrative Regulation of M di l D i S ifi i L b l d P k iMedical Device Specification, Label and Packaging Identification 행정조례: 의료기기사양, 라벨및포장표시사항표시사항

Must be in Chinese

Software Requirements 소프트웨어요구사항A il 28th 2012April 28th 2012

N d id ddi i l S f D 추가적인Need to provide additional Software Document. 추가적인소프트웨어문서가필요하다.

Agenda

1. Overview of CFDA Registration CFDA 허가의개요개요

2. Key Registration Hurdles 허가시주요고충사항3 Latest Regulatory Update최신규정개정사항3. Latest Regulatory Update 최신규정개정사항4. Case Studies and Tips 사례연구및팁

CCC mark 제품안전마크 – CCC 마크2013 A t N 522013 Announcement No.52

I h 8 di l d i d ddi i ll dIn the past, 8 medical device need to additionally testedfor CCC (China Compulsory Certification) mark.

Medical X-ray diagnostic equipment, Hemodialysis equipment, Hollow fiber dialyzersHollow fiber dialyzers, Extracorporeal blood circuit for blood purification equipment, Artificial heart-lung machines, ECGsECGs, Implantable cardiac pacemakers Rubber condoms.

Do not need as of May 2, 2013.CCC마크는 8개의료기기에적용된적이있으나 203년 5월 2일이후CCC 마크는 8개의료기기에적용된적이있으나 203년 5월 2일이후의료기기에 CCC마크를요구하지않는다.

Administration Level Change - CFDA 승격M h 22 d 2013March 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.

승격 /독립성강화 /이전규정및정책은유효승격 / 독립성강화 / 이전규정및정책은유효

http://www.sfda.gov.cn/WS01/CL0051/79254.html

Software Requirements 소프트웨어요구사항A il 28th 2012April 28th 2012

N d id ddi i l S f D 추가적인Need to provide additional Software Document. 추가적인소프트웨어문서제출이요구된다.

Software Requirements소프트웨어요구사항A il 28th 2012April 28th 2012

웨어형식Software type: 소프트웨어형식

Independent software: Software as medical device or accessory, such p y,as processing software, data software.

독립적인소프트웨어: 의료기기혹은부속품이되는소프트웨어제품.

Software component: Software as component of medical device, part or accessory, such as embedded software, control software.

소프트웨어부품: 의료기기의부품인소프트웨어Specialized software: such as individual customer-made software.

특별한소프트웨어: 사용자특화된소프트웨어

Software Requirements 소프트웨어요구사항A il 28th 2012 ( t’d)April 28th 2012 (cont’d)

웨어의안전분Risk Classification of Software 소프트웨어의안전분류Class A: No injury or damage to health is possible

A등급: 건강에대해상해나손상이불가능하다A등급: 건강에대해상해나손상이불가능하다Class B: Non-SERIOUS INJURY is possible

B등급: 엄중하지않은상해가가능하다Class C: Death or SERIOUS INJURY is possible

C등급: 사망혹은엄중한상해가가능하다.

Quantity and level of detail depends on software risk y pclassification. 상세한내용의양과수준은소프트웨어위험분류에달려있다.

Software Requirements – Contents소프트웨어요구사항 내용소프트웨어요구사항 –내용April 28th 2012 (cont’d)

1. Basic Information（基本信息）기본정보

1 1 Product Identification（产品标识）제품명칭1.1 Product Identification（产品标识）제품명칭1.2 Safety Class （安全性类别）안전등급1 3 Architecture Function（结构功能）아키텍처기능1.3 Architecture Function （结构功能）아키텍처기능1.4 Hardware Relationship（硬件关系）하드웨어관계1 5 O ti E i t （运行环境）동작환경1.5 Operation Environment （运行环境）동작환경1.6 Indications （适用范围）용도1.7 Contraindications （禁忌症）금기사항

1.8 Listing History （上市历史）변경이력

Software Requirements - ContentsA il 28th 2012 ( t’d)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）（验 与确认）2.6 Defect Management （缺陷管理）

2 7 Revision History （修订历史）2.7 Revision History （修订历史）2.8 Clinical Evaluation （临床评价）

3 C Al ith （核心算法）3. Core Algorithm （核心算法）

Some Class II Devices are Exempted From Cli i l E l ti D t (国食药监械[2011]475号)Clinical Evaluation Data (国食药监械[2011]475号)일부 2등급기기는임상평가데이터면제

A list of these devices exempted from clinical evaluation dataDocument of comparison results shall be provided 동등성비교표제출해야한다제출해야한다.

EMC Requirements 전자파적합성요구사항国食药监械[2012]151号国食药监械[2012]151号

医 电气设备第 部 安 求YY0505-2012 医用电气设备第1-2部分：安全通用要求并列标准：电磁兼容要求和试验

(Harmonized to IEC60601-1-2 : 2004: Medical electrical equipment Part 1 2:General requirements for safetyequipment—Part 1-2:General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests)equ e e s a d es s)

The date of taking effect (submit EMC report)The date of taking effect (submit EMC report) 전자파성적서제출시기

Class III Device : 1st Jan 2014 3등급 2014년 1월1일Class III Device : 1 Jan 2014 3등급 2014년 1월1일Class II Device : 1st Jan 2015 2등급 2015년 1월1일

Label & package marks 라벨및포장표시사항国食药监械[2012]280号国食药监械[2012]280号

It must include Chinese label/package marks, other language is allowed. 중국어를기본적으로표시해야하고부가적으로다른언어도허용된다하고부가적으로다른언어도허용된다.

The procedure of producing Chinese Label/package p p g p gmarks must be included in production of device, under manufacture quality system control. 중국어라벨/포장은제품을생산하는곳에서해야한다제품을생산하는곳에서해야한다.

It is no more allowed to paste the labeling by agent afterIt is no more allowed to paste the labeling by agent after device is shipped to China. 중국선적이후에라벨링부착은허용하지않는다.

Factors influence approval time승인시간에영향을주는요인승인시간에영향을주는요인

Quality of the documentation 문서의품질

Writing YZB and Software Documents YZB 및소프트웨어

문서의작성

Time frame of actual testing실제시험소요시간Time frame of actual testing 실제시험소요시간

Re-work 재작업

Language Barrier (All documents must be in Chinese) 언어장벽

(모든문서는중국어로작성되어야한다.)

Agenda

1. Overview of CFDA Registration CFDA 허가의개요개요

2. Key Registration Hurdles 허가시주요고충사항3 Latest Regulatory Update최신규정개정사항3. Latest Regulatory Update 최신규정개정사항4. Case Studies and Tips 사례연구및팁

Case Study: Problem

Search legal / afterSearch legal / after--sale agent first, then sale agent first, then initiate product registration. initiate product registration.

Delay Registration

Solution:

Hire a local 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, p ,

Delay Registration

Search for distributorSearch for distributor

TestingDraft

Product Standard Assembly DossierCFDA Assessment

Registration

6 ~ 8 months 4 ~ 6 months Start selling right after g gfinding distributor

Product Agent for CFDA RegistrationProduct Agent for CFDA RegistrationAfter-Sale Agent for CFDA Registration

Case Study 2: Problem

Do not know how to write YZBDo not know how to write YZB

Delay Registration

Solution:

Hire Professional Local Expert

To write YZB based on your product

Established product category documentation

Delay Registration

Case Study 3: Problem

Do not know how to write Do not know how to write Software Software DocumentsDocuments

Delay Registration

Solution

Professional Local Expert

To write software requirement document based on your software

documents

Delay Registration