China

서브 비주얼

Asia

China Veitnam Seondary cell Japan JIS(Japan)

Procedure for hygiene approval

For cosmetic, CFDA hygiene approval is required(Imported product needs approval prior to import).

1) Preparation stage

Liabilty company in China (1, 5 months)

- Senior in Liabilty company in China, write authorization letter
- Authorization letter authentication (Korea, China), ID registration in CFDA

Common

- Composition, change slogan in box based on Chinese regulation
- Nomeclature for product in Chinese (Including brand)
- Other document (Free sales, CDA, etc.) need to be prepared prior to completion of product inspection

2) Product inspection

비특수용도 화장품(2~3개월) → 미백용도 화장품(4~5개월) → 미백+SPY화장품(6~7개월)

3) Administration procedure

신청 → CFDA 행정수리,서비스센터 형식검사 → 보건식품 심사센터 기술심사 → CFDA 심사결정 → CFDA 행정수리 서비스센터 발급

- CFDA administration repair service center : Completion of data and formal inspection (5 days)
- Sanitary food evaluation center : Special use cosmetic technic evaluation (90 days)
- CFDA : Evaluation and decision on issue (20 days, if necessary maximum 10 days can be extenede)
- CFDA administration repair service center :Issue (Within 10 days)

KTR service by stage

1) First stage registration of authorization letter , Composition, Outer packaging review

업체문의(안내서 발송) → 성분내 금지성분, 제한 성분 함유 여부 검토, 견적 → 위생증 취득 품목 확정/인증대행계약/대행비납부/수권서 준비 → 자료안내, 준비(수권서, 성분, 외포장)

2) Inspection and evaluation stage, Cosmetic inspection, Administrative process

A. Test inspection

시험검사(특수:4~5개월, 비특수:2~3개월) → 행정허가 검사 신청표[제품 중문명, 제품처방(성분표), 제품설명서(중문), 제품샘플. *제품 용량에 따라 필요한 샘플 수량 준비] → 검사보고서 수령

B. Technical evaluation

기술심사 절차도

1) 기술심사(특수용도:90일, 비특수:면제)
2) (비)특수용도 화장품
1. 1. 행정허가 신청표
2. 2. 제품의 중문명칭 명명 근거
3. 3. 제품처방 (성분표)
4. 4. 제품공정도 및 서술
5. 5. 품질 안정통제요구
6. 6. 제품원포장 (라벨, 설명서포함)
7. 7. 검사보고서
8. 8. 위허물질의 안정성 평가자료
9. 9. 효능성분 사용근거 과학문헌자료
10. 10. 수권서 사본 및 사업자등록증
11. 11. 광우병 관련 물질 금지 승낙서
12. 12. 생산과 판매 증명서 MCIA발급)
13. 13. 허가검사기관에서 봉인한 미개봉 시판제품 1개
14. 14. 제품기술요구
※ 비특수용도는 9번 절차 제외

3) Evaluation of completed stage and result

완료단계 심사절차

1.행정심사 20일내(최장 30일)
2-1. NO(부적합) : [CFDA 행정절차] 서류 보완 후 재신청

2-1. YES(적합) : [KTR 안내 업체 준비] 허가증 발급(10일 내)
3. [KTR 안내 업체 준비] 허가증 원본 전달
4. [KTR 서비스] 사후 관리 - 제출자료 보관, 연장신청서기 통보, 중문 라벨 작성 안내

One-Stop Solution to get approval in hygiene in cosmetic product

화장품류 위생허가를 위한 원스탑 솔루션 절차도

중국 화장품류 위생허가 획득(One-Step Solution)
- 재중책임회사 - KTR 상해법인, 수권계약, 수권서 CFDA 등록
- 컨설팅 - 제품처방(성분표), 내외부 패키지 문안, 제품의 중문명
- 양식제공·작성안내 - 서류 준비 안내, 서류 양식 안내, 서류 작성 안내
- 위생허가 대행 - 화장품류 위생허가, 신원료 위생허가, 위생허가 연장·변경
위생허가 제출자료 보관, 연장기간 안내 등 사후관리

Chinese Medical device Registration System (1)

Registration System

All medical devices must obtain prior approval from China Food and Drug Administration (CFDA) in order to be sold in China.

※ Related Law: Medical device Registration Administrative System (CFDA Act Item No. 4, July 30th, 2014), Medical device Supervision Administration Ordinance (State Council Act Item No. 650, March 7th, 2014)

Institution of Authorization: China CFDA (former SFDA)

A Chinese State Council affiliated organization (Cabinet Ministerial level) in charge of administration and supervision of medical devices; equivalent to Korean FDA

Classification Rating

중국 의료기기 등록 분류 등급 - 분류, 정의, 임상여부, 인허가
Classification	Definition	Clinicality	Licensing
First Rate	Low risk medical device that can be guaranteed its safety and validity through general regulation	(Exemption)	Report
Second Rate	Middle risk medical device that can be guaranteed its safety and validity through strict control and management	(Exemption)	Register
Second Rate		Clinical
Third Rate	Relatively high risk medical device that can be guaranteed its safety and validity through special measures, and strict control and management	(Exemption)
Third Rate		Clinical

Chinese Medical Device Registration Procedure

중국의료기기 등록절차

1.계약체결 (위탁계약서 체결)
2.등급분류 (자료취합, 등급분류 판정)
3.서류작성 (등록 방안·계획수립-[Class I, II, III], 신고/등록서류 작성)
4.제품시험
Class I : 자체/제3자 시험보고서 준비

Class II, III : 제품시험(sample발송) → IRB승인(임상시험)
5.접수
Class I : 신고자료제출

Class II, III : 등록자료 제출
6.CFDA 심사
Class II, III : CFDA 기술문서 심사
7.완료
Class I : 신고증 취득

Class II, III : 의료기기 등록증 취득

Chinese Medical Device Administrative Registration Fee

CFDA (Administrative) Registration Fee

Establishment and imposing commencement as of May 27th, 2015

항목분류에 따른 중국산 제품, 수입산 제품의 CFDA 행정 등록비
Item Classification		Chinese Product	Imported Product
Second Rate	Initial Registration	Independently established by region(省) (regional price, Ministry of Finance)	RMB 210,900 Yuan
	Modification of Registration	Independently established by region(省) (regional price, Ministry of Finance)	RMB 42,000 Yuan
	Registration Extension (every 5 years)	Independently established by region(省) (regional price, Ministry of Finance)	RMB 40,800 Yuan
Third Rate	Initial Registration	153,600 Yuan	RMB 308,800 Yuan
	Modification of Registration	RMB 50,400 Yuan
	Registration Extension (every 5 years)	RMB 40,800 Yuan
	Clinical Test Evaluation Ratification (High-risk medical device)	RMB 43,200 Yuan

Introduction

Service details

※ Includes Invitro Diagnostic (IVD) Product Registration

서비스 분류에 따른 내용, 비고
Classification	Detail	Note
Confirmation of Classification	Professional Decision of Classification	Decision based on Medical Device Regulations
Confirmation of Classification	Official Decision of China Food and Drug Examination Laboratory (affiliation of CFDA) - request delegation	New technology, multifunctional complex products, etc.
Legal Representative	Act as a legal representative	During initial registration period
Initial Registration	In charge of all registration delegation	Establish plan/measures, technical translation, compose necessary documents, perform local test requests, solve problems
Extended Registration	Delegate to extend registration before expiry date	Initial registration validation duration (5 years)
Registration Modification	Delegate for modification of registration	Name of registrant/elegate, address, etc.
Registration Modification	Delegate for modification of approval	Product name, required technique, specification, original address, etc.
Reissuance of Registration Certificate	Delegate for reissuing the registration certificate	Reissuance due to the loss of original certificate, etc.
Miscellaneous	Market research, problem solving	Market regulation, case of same product registration, etc.

Supervisor Contact Information

Shanghai

Shanghai 문의처 - Name, Tel, Ext, E-mail
Name	TEL	Ext	E-mail
金芝瑛 Jiyoung Kim	(86) 021 56420122	803	kjy@ktr.or.kr
王婷 Wang Ting		816	wangting@ktr.or.kr
张晶 Zhang Jing		812	zhangjing@ktr.or.kr
俞晓静 Yu Siaojing		815	yuxiaojing@ktr.or.kr

Qingdao

Qingdao 문의처 - Name, Tel, E-mail
Name	TEL	E-mail
池允珪 Ji yoon gyu	86-(0)532-6895-7747	jiyoongyu@ktr.or.kr
吕翠翠 Lv cui cui	86-(0)532-6895-7747	lvcuicui@ktr.or.kr
仉薇薇 Zhang wei wei	86-(0)532-6895-7748	zww@ktr.or.kr
袁蕾蕾 Yuan lei lei	86-(0)532-6895-7747	yuanleilei@ktr.or.kr

Shenzhen

Shenzhen 문의처 - Name, Tel, E-mail
Name	TEL	E-mail
朴珉宇 Park min woo	86-(0)755-8321-8491	parkmw@ktr.or.kr
陈立 Chen li	86-(0)755-2391-9859	li.chen@ktr.or.kr
陈洵儿 Chen xun er	86-(0)755-8321-8491	chenxuner@ktr.or.kr

Shanghai 문의처 - Name, Tel, Ext, E-mail
Name	TEL	Ext	E-mail
安友永 AN Yoo Yeong	(86) 021 56420122	807	markan@ktr.or.kr
李成 Li cheng	806	carrie@ktr.or.kr
朴龙日 Piao long ri	804	longripiao@ktr.or.kr

Shanghai 문의처 - Name, Tel, Ext, E-mail
Name	TEL	Ext	E-mail
李俊昊 Jun Ho LEE	(86) 021 56420122	805	junho78@ktr.or.kr
赵贞丽 Zhenli Zhao	805	zhenli@ktr.or.kr

According to the People's Republic of China Food Safety Law of 2015, Import and Export Products Regulatory Law and its implementations, importing prepackaged food products must comply with inspection quarantine such as China National Standards and China National Sanitation Standards; Chinese label must comply with Prepackaged Food Labeling Principles (GB7718-2011), Prepackaged Food Nutrition Labeling Principles (GB28050-2011), Prepackaged Special Food Labeling Principles (GB13432-2013), and other Chinese related laws and administrative regulations.

According to the People's Republic of China Food Safety Law of 2015 and the Sanitary Food Administrative Measures, sanitary food exported to China must acquire registration permit by registering to China Food and Drug Administration

KTR Shanghai offers a one-stop support service of food export to China, based on its long-term cooperation with various food import and export institutions CIQ (Customs, Immigration and Quarantine), CFDA approved test institutions, China government operated certification test institution, law firms, major regional import, export and customs agencies, and import and export product region.

Service offered:

1. Prior Review Service (technical and legal support)

- Product category (regular food, sanitary food, or functional food)
- Review of suitability for regular food mixture and sanitary standards in accordance with Chinese food related law and standards
- Prior review of suitability for sanitary food registration in terms of sanitary food mixture, production progress, quality standard, development basis, etc.

2. China Food Export Review Service (mixture, label, customs, inspection)

- Mixture review, analysis of inspection sanitary standard
- Registration of overseas company in Chinese AQSIQ system
- Perform nutrition tests (if necessary), Chinese label design and registration (upon exportation)
- Issue Consulting Report on food exportation to China

3. Registration delegation of sanitary food with CFDA

- Prior review of suitability for sanitary food registration in terms of mixture, production progress, quality standard, development basis, etc.
- Document preparation, translation, administer testing (hygiene, stability, functional elements testing, safety testing, function verification test, physical test) with KTR affiliated testing institution (CFDA approved institution), Document preparation, CFDA registration application, CFDA administrative and technical evaluation, retest
- CFDA final approval evaluation, additional documents (immediate solution of a problem, through cooperation with CFDA evaluation professional), issue registration license

4. Trademark Registration

- Trademark registration, establish Chinese office, legal service such as a trademark dispute

Supervisor Contact Information

Shanghai

Shanghai 문의처 - Name, Tel, Ext, E-mail
Name	TEL	Ext	E-mail
王皑 AI WANG	(86) 021 56420122	811	aiwang.asia@ktr.or.kr
黄文旭 Huang wen xu	(86) 021 56420122	814	huangwx@ktr.or.kr

Qingdao

Qingdao 문의처 - Name, Tel, E-mail
Name	TEL	E-mail
池允珪 Ji yoon gyu	86-(0)532-6895-7747	jiyoongyu@ktr.or.kr
吕翠翠 Lv cui cui	86-(0)532-6895-7747	lvcuicui@ktr.or.kr
仉薇薇 Zhang wei wei	86-(0)532-6895-7748	zww@ktr.or.kr
袁蕾蕾 Yuan lei lei	86-(0)532-6895-7747	yuanleilei@ktr.or.kr

Shenzhen

Shenzhen 문의처 - Name, Tel, E-mail
Name	TEL	E-mail
朴珉宇 Park min woo	86-(0)755-8321-8491	parkmw@ktr.or.kr
陈立 Chen li	86-(0)755-2391-9859	li.chen@ktr.or.kr
陈洵儿 Chen xun er	86-(0)755-8321-8491	chenxuner@ktr.or.kr

Point of contact

담당자 - Name, Tel, E-mail
Name	Position	Task	Tel	E-mail
Park Jinjae	Manager	KC, CB, CCC, CE etc Global Certificate	+82-2-2164-1479	jjpark@ktr.or.kr