Tags: | CFDA | Cosmetics | Cosmetics | 食药监局 | 化妆品 | 化妆品 |

On 17 Jan, 2017, The China Food and Drug Administration (CFDA) and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) have jointly issued a pilot measures about the record-filing of non-special-purpose cosmetic imports in Shanghai’s Pudong New Area.

From 1 March 2017 to 21 December 2018, foreign non-special-purpose cosmetics imported into China through the port of Pudong New Area for the first time , and whose China Responsible agency (CRA) is registered in the Pudong New Area, Then the new record-filing procedure (Express Channel) will replace the current regular CFDA registration procedure.

New "Express channel" record-filing procedure Compare with the regular CFDA registration procedure, mainly is can save at least 50% time;

The regular CFDA registration procedure is issue certificate after the technical review, total time need 5-9 months,

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



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

Compare Itmes	Regular CFDA registration process	New SFDA Record-Filing Process (Express Channal)
Total Timeline	5-9 month	2-3 months
Cost	Enquire us for	Same
Main difference of the process	Issue certificate AFTER technical evaluation，	Issue Record filing Number BEFORE technical evaluation
Project Name	Imported non-special Cosmetics CFDA administrative licensing	Imported non-special Cosmetics Shanghai FDA Record-Filing
Legal basis	National regulation	Pilot measures
Implementation time	Since 2008	From 1-Mar-2017 to 21-Dec-2018
Administration department	CFDA in Beijing	Shanghai local FDA
Authorized application	China Responsible agency (CRA)	China Responsible agency (CRA)
Requirement for CRA	Chinese Company registered in china mainland	Chinese Company registered in Shanghai Pudong New area
Duty of CRA	Responsible for CFDA registration only	Responsible for SFDA filing, import process, product quality & safety responsibility on the market
Import Port	All port in China mainland	Port in Shanghai Pudong new area only
Importer	All import company in China	Only the CRA in Shanghai Pudong  new area
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 Shanghai FDA Shanghai 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	3 months
Valid	4 years	Undetermined