【CODEX】2014 No.650 医疗器械监督管理条例（1-2）-EN
医疗器械监督管理条例
Regulations for the Supervision and Administration of Medical Devices
第一章 总 则
Chapter I General Provisions
第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。
Article 1. The Regulations hereby formulated with a view to ensuring safety and effectiveness of medical devices, protecting human health and life safety.
第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。
Article 2. All units or individuals engaged in the research and development, manufacturing, distribution, use, supervision and administration of medical devices within the territory of the People’s Republic of China shall comply with the Regulations.
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