There Will Be No Way to Sell & Use Illegal Sodium Hyaluronate Those Without CFDA Registration Certificate

For now, there are awful phenomena that many medical institutions and beauty salons selling and using illegal sodium hyaluronate for in China, such as HA fillers without registration certificate or qualification certificate into consumers. In order to safeguard consumers' legitimate rights and interests, and ensure people can use sodium hyaluronate safety, CFDA will boot up the task together with MIIT and other government departments to fight the illegal sold and used sodium hyaluronate.

On Oct 14^th, 2015, CFDA has issued the official announcement for this anti-illegal activity. The main content is as following:

1. Objective

The objective of this program is to crack down on the illegal business activity in selling and using sodium hyaluronate without CFDA certifiate. CFDA will work with MIIT and other government departments to investigate into and deal with major cases, and exposure the illegal enterprises and departments, to generate a sufficient deterrent in social. Constantly improving the operating mechanism and formatting the new situation for work collaboratively.

2. Assignment of responsibility

2.1 Food and Drug administration department.

CFDA will strengthen supervision for sodium hyaluronate in production and management enterprises and use units, and investigate and prosecute the illegal activities such as producing sodium hyaluronate for injection without registration certificate or production certificate.

2.2 Health and Family Planning Commission

Health and Family Planning Commission will strengthen supervision of aesthetic and medical institutions, and make a penalty for those institutions which use illegal sodium hyaluronate or do not obtain the Practicing License of Medical Institution.

2.3 Industrial and Commercial Administration

Industrial and Commercial Administration will tighten regulation for aesthetic and medical institutions. For the aesthetic and medical institutions without the Practicing License of Medical Institution, Industrial and Commercial Administration can transfer the institutions to Health and Family Planning Commission. For the institutions which use sodium hyaluronate without Trading Certificate, they can report them to Food and Drug Adminitration.

2.4 Telecommunications Administration

Telecommunications Administration will strengthen supervision of internet. For the institutions which issue false illegal advertisement, engage in internet operational activities on their own without approval and registration and refuse to reform, telecommunications administration can revoke the trading certificate of internet information server or log out the website approve, and stop relevant internet access service according to the law.

2.5 Public security organs

Public security organs will put the cases which about illegal producing, selling and using sodium hyaluronate on file for investigation and prosecution.

3. Temporal Arrangement

Stage 1: Centralized renovation (Oct 2015~Jan 2016). CFDA print and distribute the work program with other related departments. All the provincial departments formulate the physical measures according to the work program, and establish coordination mechanism.

Stage 2: Targeted inspection (Jan 2016~Feb 2016). CFDA conducts targeted inspection in some provinces.

Stage 3: Sum up and Consolidation (Mar 2016). Across-the-board summarizing the working situation of this specific project.

Under the current situation that the regulation of sodium hyaluronate for injection will be stricter, the oversea enterprises shall pay more attention on the relevant regulations of sodium hyaluronate for injection. There's something you should know that you shall get the registration certificate for your product, and your distributors shall get the trading certificate. Otherwise, selling or using your product will be illegal.

SOURCE: http://www.sda.gov.cn/WS01/CL1105/132280.html

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