The Required Materials For Obtaining Skin Care Products Registration Permit from CFDA
1.The applicant company in Mainland China seals and signs the letter of authorization letter, and the signed and sealed authorization letter must be notarized.
2.The photocopy of The applicant company’s business license
3.Product formula in both Chinese and English
4.User’s manual(or Chinese translation of the external package of the product)
5.Samples 16-80 pieces/type. Samples must have packages for final sales in China market, and of the same production batch. The exact sample quantity depends on the package size and how the product is used.
6.Product Quality and Safety Control Requirements(In Chinese and English).
7.Safety assessment materials about product may contain safety risk substances.
8.Products designed for pregnant women, breast feeding women, children and infants shall provide formula design principles based on safety considerations(including test report of formula), the choosing principles and requirements of materials, manufacturing techniques, quality control documentation.
9.Brief of manufacturing techniques and flow chart of manufacturing. For hair breeding products and breast beauty products, functional components and scientific literature materials the said functional components are applied and based on.
10.The original certificate/documentation that indicates the product(s) are allowed to be produced and sold in country/region of manufacturing (the certificate shall be issued by local government department or Industry Association. The original copy shall be notarized in mainland China)
11.In case that the product(s) are not produced by the applicant company
-if the applicant company and the manufacturer are in the same group, original documentary evidence that proves they are in the same group must be provided.
-if the applicant company and the manufacturer are not in the same group, original commissioned processing contract and original ISO9001 quality system certificate or original GMP certificate of the manufacturer shall be provided. If the certificates are in photocopy, the documentary evidence from the issuing organization shall be provided, or notarial certificate that proves photocopy conforms to the original copy shall be provide.
2.The photocopy of The applicant company’s business license
3.Product formula in both Chinese and English
4.User’s manual(or Chinese translation of the external package of the product)
5.Samples 16-80 pieces/type. Samples must have packages for final sales in China market, and of the same production batch. The exact sample quantity depends on the package size and how the product is used.
6.Product Quality and Safety Control Requirements(In Chinese and English).
7.Safety assessment materials about product may contain safety risk substances.
8.Products designed for pregnant women, breast feeding women, children and infants shall provide formula design principles based on safety considerations(including test report of formula), the choosing principles and requirements of materials, manufacturing techniques, quality control documentation.
9.Brief of manufacturing techniques and flow chart of manufacturing. For hair breeding products and breast beauty products, functional components and scientific literature materials the said functional components are applied and based on.
10.The original certificate/documentation that indicates the product(s) are allowed to be produced and sold in country/region of manufacturing (the certificate shall be issued by local government department or Industry Association. The original copy shall be notarized in mainland China)
11.In case that the product(s) are not produced by the applicant company
-if the applicant company and the manufacturer are in the same group, original documentary evidence that proves they are in the same group must be provided.
-if the applicant company and the manufacturer are not in the same group, original commissioned processing contract and original ISO9001 quality system certificate or original GMP certificate of the manufacturer shall be provided. If the certificates are in photocopy, the documentary evidence from the issuing organization shall be provided, or notarial certificate that proves photocopy conforms to the original copy shall be provide.
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