【英语角】 关于《医疗器械监督管理条例》 的一些英文表达

Registration and Filing of

Medical Devices

二、关于医疗器械注册、备案管理

As of June 1, 2021, prior to the issuance and implementation of relevant provisions on registration and filing supporting the new Regulations, medical device registrants and filing applicants shall continue to apply for registration and conduct filing in accordance with the current provisions. The requirements for clinical evaluation of medical devices shall be implemented in accordance with Article III of this Announcement. Medical products administration shall carry out the registration and filing in accordance with the currently specified procedures and time limits.

自2021年6月1日起，在新《条例》配套的注册、备案相关规定发布实施前，医疗器械注册申请人、备案人继续按照现行规定申请注册和进行备案。有关医疗器械临床评价要求，按照本公告第三条执行。药品监督管理部门按照现行规定的程序和时限开展注册、备案相关工作。

Clinical Evaluation Management of Medical Devices

三、关于医疗器械临床评价管理

As of June 1, 2021, medical device registrants and filing applicants shall carry out clinical evaluation in accordance with the new Regulations. Clinical evaluation may be exempted for those complying with the provisions for exemption from clinical evaluation in the new Regulations; for the purpose of performing clinical evaluation, it is feasible to prove the safety and effectiveness of the medical device by carrying out clinical trials according to the product characteristics, clinical risks and the existing clinical data or by performing analysis and evaluation on the clinical literatures and clinical data of predicate medical devices; clinical trials shall be carried out for medical devices whose safety and effectiveness cannot be proved by the existing clinical literatures and clinical data. Prior to the issuance and implementation of relevant documents on exemption from clinical evaluation, the current Catalogue of Medical Devices Exempted from Clinical Trials shall be referenced for the Catalogue of Medical Devices Exempted from Clinical Evaluation.

自2021年6月1日起，医疗器械注册申请人、备案人根据新《条例》规定开展临床评价。符合新《条例》规定的免于临床评价情形的，可以免于临床评价；进行临床评价， 可以根据产品特征、临床风险、已有临床数据等情形，通过开展临床试验，或者通过对同品种医疗器械临床文献资料、临床数据进行分析评价，证明医疗器械安全、有效；已有临床文献资料、临床数据不足以确认产品安全、有效的医疗器械，应当开展临床试 验。在免于临床评价的相关文件发布实施前，免于进行临床评价医疗器械目录参照现 行免于进行临床试验医疗器械目录执行。

Production Licensing and Filing Management of Medical Devices

四、关于医疗器械生产许可、备案管理

Prior to the issuance and implementation of relevant provisions on production licensing and filing supporting the new Regulations, medical device registrants and filing applicants shall handle the production licensing, filing and entrusted production in accordance with the existing rules and normative documents.

在新《条例》配套的生产许可、备案相 关规定发布实施前，医疗器械注册人、备案人办理生产许可、备案和委托生产按照现有规章和规范性文件执行。

Distribution Licensing and Filing Management of Medical Devices

五、关于医疗器械经营许可、备案管理

Medical device sold by its registrant and filing applicant at their residence or manufacturing site may not apply for medical device distribution licensing or filing, but shall comply with the specified distribution conditions; for Class II and Class III medical devices stored and sold at other sites, application for medical device distribution licensing or filing shall be made as required.

医疗器械注册人、备案人在其住所或者生产地址销售其注册、备案的医疗器械，无需办理医疗器械经营许可或者备案，但应当符合规定的经营条件；在其他场所贮存、销 售第二、三类医疗器械的，应当按照规定办理医疗器械经营许可或者备案。

NMPA has drafted a Catalogue of Class II Medical Devices Exempted from Distribution and Filing, for which public comments are currently solicited. After being issued, the Catalogue shall be executed.

国家药监局已起草有关免于经营备案的 第二类医疗器械产品目录，目前正在公开征 求意见。产品目录发布后，按目录执行。

Investigation and Punishment of Illegal Acts of

Medical Devices

六、关于医疗器械违法行为的查处

Where an illegal act of medical device occurs before June 1, 2021, the Regulations before revision shall apply. However, if the act is not considered illegal or the punishment is relatively light according to the new Regulations, the new Regulations shall apply. Where an illegal act occurs after June 1, 2021, the new Regulations shall apply.

医疗器械违法行为发生在2021年6月1日 以前的，适用修订前的《条例》，但依据新 《条例》认为不违法或者处罚较轻的，适用 新《条例》。违法行为发生在2021年6月1日 以后的，适用新《条例》。

原文链接：中国食品药品国际交流中心

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