Notice of the State Food and Drug Administration on Regulating the Labeling and Packaging Labeling of Overseas Medical Devices

The food and drug supervision authorities (drugs supervision bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government, relevant units:

In order to strengthen the supervision and management of medical devices and ensure the safety of the public’s use of machinery, according to the “Management Regulations for Medical Device Instructions, Labels, and Packaging Labeling” (Order No. 10 of the State Food and Drug Administration, hereinafter referred to as “Management Regulations”), it is now regulated overseas. The relevant matters concerning the labeling and packaging of medical devices are as follows:

1. Medical devices sold and used within the territory of the People's Republic of China shall be accompanied by labels and packaging labels in accordance with the "Administrative Regulations." The content of the label and package identifier text must be in Chinese, and other languages ​​can be added. Overseas medical devices that are not accompanied by Chinese labels and packaging marks may not be sold or used.

2. An overseas medical device manufacturing enterprise shall establish a control procedure for ensuring that its medical devices sold and used in China are in conformity with the "Regulations" in the quality management system, form a document, and implement it effectively to ensure its sales and use in China. The medical devices are safe and effective.

3. The meanings of the terms and terms referred to in this Notice are the same as those in the relevant nouns and terms in the "Management Regulations" and "Measures for the Administration of Registration of Medical Devices" (Order No. 16 of the State Food and Drug Administration).

This notice will come into effect on April 1, 2013.

State Food and Drug Administration

September 24, 2012