目录简介 | Article 1 These Provisions are enacted according to the Regulation on the Supervision and Administration of Medical Devices for the purpose of regulating the manuals, labels and package marks of medical devices, and ensuring the safety in the use of medical devices.
Article 2 Medical devices sold or used within the territory of the People's Republic of China shall be accompanied by manuals, labels and package marks according to these Provisions. For the easy-to-use products, one or two items of manuals, labels and package marks may not be furnished if State Food and Drug Administration (hereinafter referred to as SFDA) has so provided.
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