【CODEX】医疗器械生产监督管理办法-中英双语PDF

医疗器械生产监督管理办法

Provisions for the Supervision of Medical Device Manufacturing

第一章 总则

第一条　为加强医疗器械生产监督管理，规范医疗器械生产行为，保证医疗器械安全、有效，根据《医疗器械监督管理条例》，制定本办法。

Article 1.        In order to strengthen the supervision and administration of medical device manufacturing, standardize the manufacturing of medical device and ensure the safety and effectiveness of medical device, according to Regulations for the Supervision and Administration of Medical Device, CFDA has formulated the Provisions.

第二条　在中华人民共和国境内从事医疗器械生产活动及其监督管理，应当遵守本办法。

Article 2.        Whoever engages in the manufacturing as well as the supervision and administration of medical device within the territory of the People's Republic of China shall abide by the Provisions.

第三条　国家食品药品监督管理总局负责全国医疗器械生产监督管理工作。县级以上食品药品监督管理部门负责本行政区域的医疗器械生产监督管理工作。

Article 3.        China Food and Drug Administration shall be responsible for the supervision and administration of the medical device manufacturing nationwide. The food and drug regulatory authorities at or above the county level shall be responsible for the supervision and administration of medical device manufacturing within their respective administrative regions.

上级食品药品监督管理部门负责指导和监督下级食品药品监督管理部门开展医疗器械生产监督管理工作。

The food and drug regulatory authorities at higher level shall be responsible for the guidance and supervision of the authority at lower level on the supervision and administration of medical device manufacturing.

第四条　国家食品药品监督管理总局制定医疗器械生产质量管理规范并监督实施。

Article 4.        CFDA formulates Good Manufacturing Practices of Medical Device and supervise the implementation of it.

第五条　食品药品监督管理部门依法及时公布医疗器械生产许可和备案相关信息。申请人可以查询审批进度和审批结果；公众可以查阅审批结果。

Article 5.        The food and drug regulatory authority timely releases information on licensing and filing of medical device manufacturing accordingly. The applicant can inquire about the progress and result of examination and approval. The public can inquire about the result of examination and approval.

第六条　医疗器械生产企业应当对生产的医疗器械质量负责。委托生产的，委托方对所委托生产的医疗器械质量负责。

Article 6.        The medical device manufacturer shall be responsible for the quality of manufactured medical device. For entrusted manufacturing, the entrusting party shall be responsible for the quality of manufactured medical device they entrust.

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