医疗器械监督管理条例-英文

R ｅ gu ｌ at ｉ on ｓRegulations for the Supervision and Administration of Medical Devices Regulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety、 Article 2 All units or individuals engaged in the research and development, production, distribution, use, supervision and administration of medical devices within the territory of the Peoples Republic of China shall ply with the Regulation、 Article 3 "Medical devices" as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in bination, including the software necessary for its proper application、 It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, 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, monitoring, treatment or alleviation of disease; 2、 Diagnosis, monitoring, treatment, alleviation of or pensation for an injury or handicap conditions;3、 Investigation, replacement or modification for anatomy or a physiological process;4、 Control of conception、 Article 4 The drug regulatory authority under the State Council is responsible for supervision and administration of medical devices nationwide、 The drug administration of the local government at county level and above is responsible for supervision and administration of medical devices in each administrative region、 The drug ...