Global Market Report Global Market Report 쉽게풀어쓴태국의료기기 화장품등록및인증절차 방콕무역관

Global Market Report 17-056 Global Market Report 쉽게풀어쓴태국의료기기 화장품등록및인증절차 방콕무역관

C O N T E N T S 목 차 요약 / 1 Ⅰ. 태국의료기기및화장품근거법령및인증기관 2 1. 정의 3 2. 근거법령 5 3. 인증담당기관 Ⅱ. 의료기기인증절차 8 1. 개관 9 2. 의료기기수입라이선스취득 11 3. 의료기기인증 17 4. 기타 Ⅲ. 화장품인증절차 18 1. 개관 20 2. 인증절차 : 화장품사전신고 23 3. 기타참고사항 Ⅳ. 대태국화장품 의료기기수출관련자주하는질문정리 26 1. 의료기기관련주요 QnA 27 2. 화장품관련주요 QnA. 전망및제언 부록 29 32 35 38 1. 전망 2. 제언 1. 의료기기및화장품인증대행기관소개 2. 태국관세청관세율조회사이트이용방법

Global Market Report 17-056 요약 - 1 -

Ⅰ 태국의료기기및화장품근거법령및인증기관 1 (Medical Device Act B.E. 2551(2008)) (Medical Devices),,,,, /,,,,,, /, (a),,,,,, (b),,,, (c),,,, (d),,, ( ), (e) (f), (g) (h) (i) (Cosmetics Act B.E. 2558(2015)),,., - 2 -

Global Market Report 17-056 2, (1) (Medical Device Act B.E. 2551(2008)/B.E. 2531(1988)) (2) (Public Health Announcement (No. 34) B.E. 2549 on Medical Device Prohibited in Import or Sale(under Medical Device Act B.E. 2531(1988)) (3) (Food and Drug Administration Ordinance 2550 B.E. on Guidance of the Certificate Document using for Importation and Guidance for the exemption at the Thai-FDA Custom office, Important Export Inspection Division (under Medical Device Act 2531 B.E.) - 3 -

(Cosmetics Act B.E. 2558(2015) (Ministrial Regulation), (Public Health Announcement),,,,,, (Consumer Protection Act B.E. 2522(1979)),,, () ( ) ( - 4 -

Global Market Report 17-056 3 인증담당기관 (Food and Drug Administration) 1974, 2003 6 (,,,,, ) * (Bureau of Import and Export Inspection) - 5 -

,,,, 5 (Pre-marketing Control):, (Post-marketing Control): :. (APRMC), (IPCS) : :,, GMP(Good Manufacturing Practice) (Ministry of Public Health) (Food and Drug Administration, Thai FDA) (Medical Devices Control Division) : 88/24 Tiwanon Road, Nonthaburi, Thailand 11000 : +66-2-590-7248 : +66-2-591-8636 : Mdcd1988@fda.moph.go.th : www.fda.moph.go.th (Ministry of Public Health) (Food and Drug Administration, Thai FDA) (Cosmetics Control Division) : 88/24 Tiwanon Road, Nonthaburi, Thailand 11000 : +66-2-590-7169, +66-2-590-8467 : +66-2-591-8468 : cosmetic@fda.moph.go.th : www.fda.moph.go.th - 6 -

Global Market Report 17-056 Ⅱ 태국의료기기인증 1 개관 (FDA) (General Medical Devices), (Notified Medical Devices), (Licensed Medical Devices) 3 ( ) : 90% ( ) : 7 ( - 7 -

2 의료기기수입라이선스취득 - 8 -

Global Market Report 17-056 - 9 -

3 의료기기인증 Glucose, Lipid profile, Liver function test, Uric acid, BUN, Creatinine, Pregnancy test, Narcotics, Hormones(Thyroid, Fertile), Tumor markers(afp, CEA, PSA), Cardiac markers (CK,CK-MB,Troponin) - 10 -

Global Market Report 17-056 : 10 1,000, 10 2,000-11 -

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Global Market Report 17-056 Jor Nor 1) 와함께 แบบคำขอแจ งรายละเอ ยดการนำเข าเคร องม อแพทย (จน. 1)) ( - 13 -

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Global Market Report 17-056 แบบ ข.พ. ๑, Khor Por 1) 작성 3x4 cm ) 3x4 cm ) - 15 -

4 기타 - 16 -

Global Market Report 17-056 Ⅲ 화장품등록및인증절차 1 개관 3 2008 (Controlled Cosmetics) 2008 (Specially Controlled Cosmetics), (Controlled Cosmetics), (General Cosmetics) - 17 -

2 인증절차 : 화장품사전신고 - 18 -

Global Market Report 17-056 หน งส อมอบอ าน าจ, - 19 -

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Global Market Report 17-056 (F-C2-1) (F-C2-2) (E-Submission) 1 1 1 1 (Product Information File) * 1, 1-21 -

3 기타참고사항 - 22 -

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Global Market Report 17-056 Ⅳ 대태국의료기기 화장품수출관련자주하는질문 1 의료기기관련주요 QnA - 25 -

2 화장품관련주요 QnA - 26 -

Global Market Report 17-056 - 27 -

전망및제언 1 전망 - 28 -

Global Market Report 17-056 - 29 -

2 제언 - 30 -

Global Market Report 17-056,,, - 31 -

ㆍ ㆍ - 32 -

Global Market Report 17-056 부록 (Appendix) - 33 -

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Global Market Report 17-056

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작성자 쉽게풀어쓴태국의료기기 화장품등록및인증절차 발행인발행처발행일주소전화홈페이지문의처 김재홍 KOTRA 2017년 12월 28일서울시서초구헌릉로 13 (06792) 02) 1600-7119( 대표 ) www.kotra.or.kr 전략시장진출지원단 (02-3460-3303) ISBN : 979-11-6097-492-8 (95320)

쉽게풀어쓴태국의료기기 화장품등록및인증절차 Global Market Report