Imported Non-special-purpose cosmetics record-filing regulation and process of China NMPA (From Nov.10, 2018)

◄ Imported Non-special-purpose cosmetics record-filing regulation and process of China NMPA (From Nov.10, 2018) ►

According to National Medical Products Administration of P.R. China (NMPA, Former CFDA) new regulation about imported Non-special-purpose cosmetics issued on November 9, 2018 ,
From November 10, 2018, Non-special-purpose cosmetics imported into China for the first time, record-filing management will replace the current CFDA approval-based approach. The National Medical Products Administration will no longer accept applications for first-imported non-special use cosmetics administrative licenses

The responsible person (Initial Importer) of the production enterprise intending to import such products should file a record with the local FDA before the first importation takes place.

New "Express channel" record-filing procedure Compare with the former regular CFDA registration procedure, mainly is can save at least 50% time;
Another mainly change is the responsible person in china will Binding with Initial Importer together;

The former regular CFDA registration procedure is issue certificate after the technical review, total time ueually need 6-9 months,

But the new "express channel" procedure is issue record-filing Number before technical review, total time can fast to 2-3 months.

The below table is the detail compare of the two process:

Compare Itmes	Former CFDA Registration Process	New Local FDA Record-Filing Process (Express Channal)
Total Timeline	6-9 month	About 3 months (Include Lab testing time)
Main difference of the process	Issue certificate AFTER technical evaluation，	Issue Record filing Number BEFORE technical evaluation
Authorized Application Agent	China Responsible Agent (CRA)	China Responsible Person (Initial Importer)
Duty of China Responsible Company	Responsible for CFDA registration only	Responsible for Local FDA Record-filing, import process, product quality & safety responsibility on the china market
Quantity of responsible persons	The cosmetics production enterprise only can authorize one responsible person in china	Can authorize multiple responsible persons in china , but each product can only authorize one
Importer	All import company in China	Only the CRA Initial Importer and its authorized Consignee
Cost	N/A	Enquire us for
Project Name	Imported non-special Cosmetics CFDA administrative licensing	Imported non-special Cosmetics Provincial FDA Record-Filing
Implementation time	Since 2008 to 11-Dec-2018	Since 11-Dec-2018
Administration department	CFDA in Beijing	Provincial FDA where the Initial importer is Located
Application Documents	1.CFDA Registration Application form 2.The copy of Applicant business license. 3.Certificate of Quality Management System (GMPc,ISO 9000,ISO 22716 Certificate ,etc.) 4.Letter of Authorization issued by the Applicant to its CFDA registration agent in China. 5.Free sales certificate or other Marketing Approval Certificate in original country 6.The cosmetics product formula table . 7.The Product quality and safety control standards. 8.Statement of undertaking on the not use of raw materials involving high risks substances (such as BSE- mad cow disease) 9.The risk substances safety testing or assessment report (Such as Dioxane, phenol, acrylamide, methanol, etc.) 10.Product original packaging label and Chinese label. 11.Production process, Diagram flow chart,etc. 12.Quality standards and Specifications for major raw materials. 13.The sealed intact product samples.	Almost same
Product test items	Microbiology, hygiene and Toxicology (Animal experiment)	Same
Process	Entrust CRA Prepare Application Documents Product testing Submit application to CFDA CFDA Format review and Technical evaluation (3-5 months) Issue Certificate Import	Entrust CRA Prepare Application Documents Product testing Submit application to Provincial FDA Provincial FDA Format review (5 days) Issue Record filing Number Import
Main difference of the process	Issue certificate AFTER technical evaluation，	Issue Record filing Number BEFORE technical evaluation (Technical evaluation will be conducted in the subsequence 3 months.)
Total Timeline (Inc test time)	6-9 month	About 3 months
Valid	4 years	Unlimited

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不同类型的GACC注册，海外申请人可以根据自身情况，选择不同的渠道进行注册申请。
1. 如果你精通GACC注册流程，可以直接向中国海关提交免费申请，其网站为：www.customs.gov.cn or www.singlewindow.cn；
2. 如果你是第一次申请，不清楚GACC注册的程序h流程，申请文件要求等，可以通过CRA中国代理机构渠道申请注册，CRA会提供专业的注册咨询服务，帮助你顺利通过GACC注册审查，尽快获得GACC注册号。

Different types of GACC registration, overseas applicants can choose different channels to apply for :
1. If you specialise in the GACC registration process, you can submit a free application directly to China Customs, website: www.customs.gov.cn or www.singlewindow.cn;
2. If you are not clear about the registration process of GACC registration, application document requirements, etc., you can apply for registration through the channel of CRA (Chinese Representative Agency) , CRA will provide professional registration services to help you successfully pass the GACC registration review and get the GACC registration number quickly.

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◄ Imported Non-special-purpose cosmetics record-filing regulation and process of China NMPA (From Nov.10, 2018) ►

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