China Releases Circular on Foreign Medical Devices

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Oct. 8 – To strengthen the supervision and administration of medical devices, China’s State Food and Drug Administration (SFDA) released the “Circular on Standardizing the Labels and Packaging Marks of Foreign Medical Devices (guoshiyaojianxie [2012] No.280, hereinafter referred to as ‘Circular’)” on September 24.

According to the “Administrative Regulations on the Instructions, Labels and Packaging Marks of Medical Devices (SFDA Order No.10, hereinafter referred to as ‘Regulations’),” the Circular regulates the relevant matters concerning the labeling and packaging marks of foreign medical devices as the following:

  • Medical devices sold and used within the territory of China shall attach labels and packaging marks according to the Regulations. The text on the labels and packaging marks shall be in Chinese, and other languages may be added. Foreign medical devices without attaching Chinese labels or packaging marks according to the Regulations are prohibited from being sold or used.
  • Manufacturers of foreign medical devices shall establish control procedures in their quality control system to ensure the medical devices sold and used within the territory of China comply with the Regulations. Such entities shall also formulate relevant documents and effectively implement such documents to ensure the safety and effectiveness of the medical devices sold and used in within the territory of China.
  • The terms and technical expressions in this Circular shall have the same meaning as those provided in the “Regulations and Administrative Measures on the Registration of Medical Devices (SFDA Order No.16).”

The Circular is scheduled to take effect on April 1, 2013.

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