Takehome:
Zhejiang has officially opened filing management for first-imported non-special use cosmetics.
CFDA previously outlined plans to expand Shanghai Pudong filing management to another 10 FTZs (see CL News). Zhejiang Zhoushan had already undergone preliminary feasibility and capacity assessment and is the next place offering imported non-special use cosmetics filing management (see CL News). The Zhejiang pilot program officially began on March 28th.
From Mar 28, 2018 to Dec 21, 2018, non-special use cosmetics can be eligible for filing management instead of registration if they are imported through the Zhejiang free trade zone for the first time and the domestic responsible person is registered in the Zhejiang free trade zone. Prior to use of the filing system stakeholders must authorize a domestic responsible person to use the national unified network platform "imported non-special use cosmetics filing management system" to apply for filing certificate prior to import. Only after obtaining a filing certificate on this system can the manufacturer import products. Provincial FDA has also established a filing information portal in Zhoushan FTZ. It takes a maximum of 5 days to get approval after submitting product dossiers (provided product is compliant etc.)
Once the filing is approved the domestic responsible person can go to Entry-Exit Inspection and Quarantine Bureau with the printed certificate generated by the filing system. Then products can be imported through the Zhejiang free trade zone and only require filing. Moreover the domestic responsible person is also responsible for the authenticity of submitted documents, and shoulders responsibility for quality and safety of imported non-special use cosmetics to ensure that the import and operation of cosmetics meet the requirements of regulations and standards. Once a product quality/safety problem occurs, the responsible person shall proactively disclose relevant information and recall the products immediately.
Besides, to ensure quality and safety of first import non-special use cosmetics, FDA will conduct supervision and inspection within 3 months after filing as well as strengthen in-process and post-marketing surveillance. If there is any incompliance, FDA will order immediate rectification or suspend import sales etc. If there is any suspected violation, FDA shall investigate and punish enterprise according to relevant laws and regulations.
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