t▓o surmount difficulties

  • encourage us to bravely forge ahead on the new hi▓storical course. Article 1 These Regulations are hereby formulated with a▓ view to strengthening the supervision and administration of medical d▓evices, ensuring their safety and effectivene

  • ss and protecting human health and life safety. Article 2 All units or individuals enga▓ged in the research and development, production, distribution, use, supervision and administr

  • ation of medical devices within the territory of the People's Republic of Chin▓a shall comply with the Regulation. Article 3 "Medical devices" as defined by these regulations refers to:

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any instrument, apparatus, appliance, material, or other article whether used alone or in c

ombination, including the software necessary for its proper application. It does not achieve its

principal action in or o▓n the human body by means of pharmacology, immunology or metabolism,

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but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, mo

nitoring, treatment or alleviation of disease; 2. Diagnosis, monitoring, treatment, al

leviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modific

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ation for anatomy or a physiological process;4. Control of conce

ption. Article 4 The drug regulatory authority under the State Council is responsible for supervision

and administra▓tion of medical devices nationwide. The drug administration of the local government at county level and above is r

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