Shanghai FDA Release Filing Management Guidance for Importation of Non-special use Cosmetics through Pudong

Takehome:

After CFDA's enforcement rules on filing management for "first import non-special use cosmetics"  (see CL), Shanghai FDA released a guide to specify requirements for application and procedures for importers/local responsible person to successfully file a record with local FDA.

How to apply

Importers shall authorize a local responsible person to submit 13 kinds of documents (see appendix 2) both online and in paper format. Before submitting the dossiers, the responsible person shall first complete online user registration. To get an account, the following documents are needed:

• Stamped and signed account application form;
• Notarized authorization certificate to designate local responsible person from foreign manufactures, with notarized Chinese translation format;
• Business license of local responsible person.

1. Online submission:

Once the responsible person successfully obtains the username and password of the account, it should login to the filing system on www.sfda.gov.cn , and submit digital format dossiers online.

The following three documents should be filled out online, and then printed in paper format for submission

• Application form of imported non-special use cosmetics;
• Chinese product name and basis of nomenclature;
• Product formula.

2. Paper format submission:

Dossiers submitted in paper format should meet the following requirements:

• All original documents should be officially sealed by local responsible person, except for the test reports, notarized documents, official certificates from third parties;
• Each document should be printed in A4 size and distinguished in different marks; put documents in required order and bind in a volume;
• Use Chinese statutory measurement unit;
• All documents in foreign language should be translated into Chinese, and Chinese version should be put in front of original one;
• Those who apply for a second time after a cancellation, should explain the cancellation and apply again; those who apply for a second time after a disapproval, should explain why and apply again and provide a copy of the disapproval letter and written documentation to prove that the former disapproval is not due to product safety concerns
• Multiple products can be listed on the same document. (Documents such as "free sale certificate", "quality control system or GMP certificate", "proof of manufacturing enterprises in different countries belong to one group company" and "company manufacturing consignment certificate", etc.) Multiple products can been included in a single application, one product is selected and must use original documents while others can use copies with a written document to indicate the name of the product using the original version. If additional products are not applied for at the same time, the copies should be notarized.

Paper documentation should be submitted to the office of import of non-special use cosmetic filing management in Shanghai Food and Drug Administration. This office is open at 9am-11:30am and 1:30pm-17:00pm on Monday to Friday (exclude holidays).

How to get filing approval

Once application is complete, shanghai FDA will check:

•  If the product falls within the scope of filing management
•  If all documents (e-copies and hard copies) are complete
•  If documents are compliant with requirements. Once compliance is established, FDA will approve the filing at once. Then online system will generate a digital filing certificate and shanghai FDA will issue a dossiers receipt.

Responsible person can bring the printed certificate and receipt to Shanghai Entry-Exit Inspection and Quarantine Bureau to go through import procedures. Then products can be imported through Pudong New Area port and marketed in mainland China.

Within 3 months after filing, Shanghai FDA will conduct technical review on all submitted dossiers. If documentation cannot ensure the safety of products, importation and sale must be stopped until the local responsible person supplements documents and the product is subsequently confirmed to be compliant. Once a violation or a quality/safety problem occurs, all products on the market will be investigated and recalled immediately (more details see: CL).

All filing information of products will be published on online filing system.

Appendix 1: Procedures of filing management

Appendix 2: 13 documents that must be submitted to authorities 

1) Application form of imported non-special use cosmetics (fill out online);

2) Chinese product name and basis of nomenclature (fill out online);

3) Product formula (fill out online);

4) Requirement for quality and safety control;

5) Graphical representation of the original product package (including the product labels and instructions); if there is a packaging specially designed for the Chinese market, the applicant shall also present the packaging design of the products (including labels and instructions);

6) Basic description of the production process;

7) Technical requirements of the product;

8) Testing report and relevant data from testing institutions approved by CFDA;

9) Safety assessment data of possible substance with safety risk in the products;

10) Letter of commitment that the ingredients meet the forbidden or restricted requirements for high risk substances from the regions with high incidence of mad cow disease;

11) Certificate of Free Sale (CoFS) of the products in the producing country (region) or original country (region);

12) Supporting documentation relating to production quality management from overseas manufacturers

13) Other documents for filing referring to "Provisions for Application and Acceptance of Administrative Licensing for Cosmetics" (File No.856 of CFDA, hereafter mentioned as "provisions")