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西安法律翻译：质量体系考核办法

发布时间：2009/11/13 阅读次数：9722 字体大小: 【小】【中】【大】

西安法律翻译:医疗器械生产企业质量体系考核办法（局令第22号）

Measures for Quality System Assessment of Medical Device Manufacturers (Juling No. 22)

2000年05月22日发布

Promulgated on May 22, 2000

《医疗器械生产企业质量体系考核办法》于2000年4月29日经国家药品监督管理局局务会审议通过，现予发布，自2000年7月1日起施行。

The Measures for Quality System Assessment of Medical Device Manufacturers has been discussed and approved in the routine meeting by State Food & Drug Administration and is hereby promulgated. The Measures shall come into effect as of July 1, 2000.

　　二○○○年五月二十二日

May 22, 2000

　　医疗器械生产企业质量体系考核办法

Measures for Quality System Assessment of Medical Device Manufacturers

　　第一条为加强医疗器械管理，强化企业质量控制，保证病患者的人身安全，根据《医疗器械监督管理条例》，制定本办法。

Article I The Measures is formulated, in accordance with the Regulations for the Supervision and Administration of Medical Devices, with a view to intensifying the management of medical devices, strengthening quality control of enterprises, and ensuring personal safety of patients.

　　第二条本办法适用于申请第二类、第三类医疗器械准产注册企业的审查及对企业的定期审查。

Article II The Measures shall apply to the examination of and regular inspection on enterprises applying for registration of approval for manufacturing Class II and Class III medical appliances.
　　下列情况可视同已通过企业质量体系考核：

Enterprises with the following conditions may be deemed to have passed the quality system assessment:
　　(一)企业获得国务院药品监督管理部门认可的质量认证机构颁发的GB/T19001和
YY/T0287（或GB/T19002和YY/T0288）标准的质量体系认证证书，证书在有效期内的。

(1) Having gotten the GB/T19001 and YY/T0287 (or GB/T19002 and YY/T0288) standard quality system certificate issued by quality authentication authority and acknowledged by the Department of Drug Supervision and Administration of the State Council, and such certificate shall be within the term of validity
　　(二)已实施工业产品生产许可证的产品,其证书在有效期内的。

(2) Having applied the license for manufacturing industrial products, and such license shall be within the term of validity
　　(三)已实施产品安全认证，企业持有的产品安全认证证书在有效期内的。

(3) Having applied the product safety certification, and such certificate shall be within the term of validity.

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