빠른상담 1800-9960

특수제품 수입허가

화장품, 의료기기 수입허가가 점점 까다로워지고 있습니다. 이에 대해 장진은 처음부터 책임지고 합리적인 가격에 대행해 드립니다.

화장품위생허가 혹은 화장품 비안등기(상하이)

해외법인 제출서류
- 성분표
- 포장파일 및 번역본
- 브랜드 수권서
- 제품 판매증명자료
- 제품품질안전공제
- 공예도 및 설명
- 샘플(미 개봉상태)
중국 재중책임회사 제출서류
- 수권접수자료
- 제품 중문명칭 제정근거
소요기간
1) 일반화장품 서류신청일로부터 4~8개월
2)기능성화장품 제품별 상이함, 최소 12개월

의료기기 수입허가

의료기기는 제품에 따라 Ⅰ, Ⅱ, Ⅲ로 구분합니다.
Ⅰ류 의료기기 제출서류
- Filing form for Class I medical devices
- Safety risk analysis report
- Product technical requirements
- Product inspection report
- Clinical evaluation documentation
- Instruction for use and label design sample of minimum sale unit
- Production and manufacturing information
- Approval documents
- Declaration of conformity
소요기간
- 2~3개월
Ⅱ, Ⅲ류 의료기기 제출서류
Primary title of application materials Secondary title of application materials
1.Application Form -
2.Proof documents -
3. The basic requirements list for medical device safety and effectiveness -
4. Summary of Data 4.1 Overview
4.2 Product Description
4.3 Model Specification
4.4 Packing
4.5 Scope and contraindication
4.6 The circumstances of referenced similar products or their predecessors (if any)
4.7 Other description content
5. Research data 5.1 Performance research
5.2 Evaluation of biocompatibility
5.3 Biosafety research
5.4 Research of sterilization and disinfection process
5.5 Research of validity and packaging
5.6 Animal research
5.7 Software research
5.8 Other
6. Manufacturing Information 6.1 Production process description of passive products / active products
6.2 Production site
7. Clinical evaluation data -
8.Product risk analysis data -
9.Product technical requirement -
10.Product registration inspection report 10.1 Register Inspection Report
10.2 Pre-evaluation comments
11.Instructions and label sample 11.1 Instructions
11.2 label sample of the minimum sales unit
12.Declaration of Conformity -
소요기간
- 2~3개월
© 2017 CHANGJINCHINA. ALL RIGHTS RESERVED.