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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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Since 1-Sep, 2018, CFDA (China Food and Drug Administration) has changed its name to NMPA (National Medical Product Administration). So, all CFDA and SFDA on this website default mean NMPA.  
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