Overseas Medical Devices in China: Chinese-Language Labels and Packaging Marks Required from April 1, 2013
To strengthen supervision over medical devices and protect public safety in their use, China's State Food and Drug Administration has issued unified requirements governing the labels and packaging marks carried by overseas medical devices.
To the food and drug administrations (drug administration bureaus) of all provinces, autonomous regions and municipalities directly under the Central Government, and to the relevant units:
To strengthen the supervision and administration of medical devices and ensure public safety in their use, and in accordance with the Provisions on the Administration of Instructions, Labels and Packaging Marks of Medical Devices (State Food and Drug Administration Order No. 10, hereinafter the "Provisions"), the following matters concerning the standardization of labels and packaging marks on overseas medical devices are hereby notified:
- Medical devices sold and used within the territory of the People's Republic of China shall carry labels and packaging marks in accordance with the Provisions. The text on such labels and packaging marks must be in Chinese, and additional languages may be attached. Overseas medical devices that do not carry Chinese labels and packaging marks as required shall not be sold or used.
- Manufacturers of overseas medical devices shall establish documented control procedures within their quality management systems, and implement them effectively, so as to ensure that the medical devices they sell and use within China comply with the Provisions and are safe and effective.
- The terms and definitions referred to in this Notice carry the same meanings as the corresponding terms and definitions in the Provisions and in the Measures for the Administration of Medical Device Registration (State Food and Drug Administration Order No. 16).
This Notice shall take effect on April 1, 2013.
State Food and Drug Administration
September 24, 2012
— Sourced from China Packaging Network (pack.cn); original link: http://news.pack.cn/show-362008.html
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