医疗器械FDAUDI食品FDA化妆品FDAVCRP注册化妆品CPNP 加拿大化妆品通报ISO13485体系建立medical device purchasing agent, China medical device sourcing, 

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    Documents needed for the CFDA registration of cosmetics

    1) Application form – application for import must be made by the manufacturer or brand holder and not the agent.
    2) The formula of the product applied for must be disclosed and may not be kept secret on the grounds of confidentiality.
    3) For special purpose cosmetics, the efficacies of the product stated must be supported by proofs and evidences such as research reports and scientific journals.
    4) For special purpose cosmetics, details of the production process have to be submitted.
    5) The Product quality and safety control requirements, e.g. quality requirements on micro organisms, heavy metals etc.
    6) The test report issued by SFDA designated testing centre; and related information
    7) The risk substances Safety Assessment Report
    8) Product of the original packaging (including product labels, product instructions); to be designed specifically for the Chinese market, packaging, product design, packaging be also be submitted (including product labels, product instructions);The language on the original packaging must be translated fully into Chinese.
    9) Certificates of production and sale in the country (region) of production of the product.
    10) Letter of undertaking on the use of raw materials involving high risks (such as mad cow disease). Letters of undertaking made by the manufacturer pledging that the product contains no bovine or sheep ingredient are now acceptable.
    11) Authorisation letter issued by the production enterprise to its responsible agency in China (if the authorisation letter is in a foreign language, it has to be translated and notarised by the China Notary).
    12) The sealed intact product samples.


    标签:   CFDA registration Cosmetics
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