New Record-keeping System was Launched for First Imported Non-special Use Cosmetics in Shanghai Pudong New Area

On 17 Jan, 2017, CFDA and AQSIQ jointly issued a Notice regarding Pilot Implementation of Record-keeping for Imported Non-special Use Cosmetics in Shanghai Pudong New Area (Notice No.7.2017). It means from 1 Mar, 2017 to 21 Dec, 2018, the regulatory regime of first imported non-special use cosmetics in Shanghai Pudong New Area will change to record-keeping from current registration. On 18 Jan, 2017, CFDA issued a Notice on Work Program of Record-keeping for Imported Non-special Use Cosmetics in Pudong New Area (Temporary, Notice No.10, 2017). The document covers the main procedures of record-keeping and documents requirements.

Background

On 19 Apr. , 2016, the State Council issued a Decision regarding Temporary Adjustment of Administrative Regulations and Approval Matters Stipulated on State Council Documents in Shanghai Pudong New Area (State Council No. 24, 2016), pointing out that there will be 11 temporarily adjusted administrative regulations and approval matters stipulated on State Council Documents from now until 21 Dec., 2018 in Shanghai Pudong New Area. This decision involves 6 issues, such as drug advertising, radioactive drugs, cosmetics, etc.

Flowchart of regulatory compliance for the first import of non-special use cosmetics in difference cases in 2017

Case 1: the products are imported from the Shanghai Pudong New Area, and the responsible person is registered in Pudong New Area (Shanghai FDA record-keeping)

Case 2: the products are imported from any other ports except Pudong New Area (CFDA registration)

Case 3: the products recorded in Shanghai FDA are no longer to be imported from Pudong New Area

Case 4: the products are imported from Pudong New Area and other ports.

It can be seen that there are different options for enterprises to choose the pre-market record-keeping or registration of imported non special use cosmetics based on actual situations. Meanwhile it is the same for special use cosmetics to be approved by CFDA. The following table summarizes the different ways of record-keeping or registration in terms of type of products, the port of entry, and the characteristics of enterprises.

Comparisons of the two ways of importing non special use cosmetics to China

Item	Registration in CFDA	Record-keeping in Shanghai FDA
Competent department	CFDA	Shanghai FDA
Authorized application	Chinese responsible person	Chinese responsible person
Requirements of responsible person	No restriction except legal entity	Registered in Pudong New Area
Responsibilities of responsible person	Application of administrative license	Import and operation, product quality and safety
Application scope	All the ports of the country	Pudong New Area in Shanghai
Required documents	Almost the same
Format review organization	Acceptance Center of CFDA	Shanghai FDA
Technical review	After the formal review, transferring to CFDA Health Food Review Center for technical review	Within 3 months after record-keeping
Issue of CFDA license or Record-keeping certificate	Issued after passing both format and technical review	Automatically generating electronic version of record number after format review for the enterprise to download and print
Format of license or certificate number	国妆备进字 J+ year number +4 digits	国妆网备进字（沪） + year number +6 digits
Term of validity	4 years	Undetermined
No longer importing recorded or registered products	No requirements	Cancellation of record-keeping information

CIRS comments

1. As is shown in the table, the biggest difference between CFDA registration and the record-keeping in Shanghai FDA is the process and the requirements of the responsible person.
2. The biggest advantage of record-keeping in Shanghai FDA is that the products can be imported for sale after format review, while CFDA requests to pass the format and technical review before the issuance of CFDA license. This is good news for enterprise in demands of rapid time-to-market.
3. The documents for CFDA registration or Shanghai record-keeping are almost the same.
4. More responsibilities are required to the responsible person for the record-keeping in Shanghai FDA compared with the CFDA registration. The responsible person registered in Pudong New Area shall bear the responsibility of product quality and safety.

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Source : http://www.sda.gov.cn/WS01/CL0087/168637.html