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 |
+86-400-6578191
