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 |
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