State Food and Drug Administration Notice on Standardizing Labels and Packaging Marks of Overseas Medical Devices
[ppzhan abstract] To strengthen the supervision and administration of medical devices and ensure the safety of medical devices used by the public, the State Food and Drug Administration regulates the labeling and packaging markings of overseas medical devices.
To the food and drug administrations (drug administrations) of all provinces, autonomous regions, and municipalities directly under the Central Government, and relevant units:
To strengthen the supervision and administration of medical devices and ensure the safety of medical devices used by the public, in accordance with the Provisions on the Administration of Instructions, Labels and Packaging Markings of Medical Devices (Order No. 10 of the State Food and Drug Administration, hereinafter referred to as the "Provisions on Administration"), the relevant matters concerning the regulation of the labeling and packaging markings of overseas medical devices are hereby notified as follows:
- Medical devices sold and used within the territory of the People's Republic of China shall be accompanied by labels and packaging markings in accordance with the Provisions on Administration. The text on labels and packaging markings must be in Chinese, and other languages may be added. Overseas medical devices that are not accompanied by Chinese labels and packaging markings in accordance with the provisions shall not be sold or used.
- Overseas medical device manufacturers shall establish control procedures in their quality management systems to ensure that the medical devices they sell and use within China comply with the Provisions on Administration, document such procedures, and effectively implement them, so as to ensure that the medical devices they sell and use within China are safe and effective.
- The meanings of the terms and definitions involved in this Notice are the same as those of the relevant terms and definitions in the Provisions on Administration and the Measures for the Administration of Medical Device Registration (Order No. 16 of the State Food and Drug Administration).
This Notice shall come into force on April 1, 2013.
State Food and Drug Administration
September 24, 2012
— This article is reposted from China Packaging Network (pack.cn). Original link: http://news.pack.cn/show-362008.html
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