|
|
|
Notice by the Department of General Affairs of the National Medical Products Administration of Matters concerning Further Efforts to Strengthen the Administration of Mandatory Industrial Standards for Medical Devices
[Effective]
|
|
国家药监局综合司关于进一步加强医疗器械强制性行业标准管理有关事项的通知
[现行有效]
|
|
|
|
|
|
|
|
|
|
|
|
| Notice by the Department of General Affairs of the National Medical Products Administration of Matters concerning Further Efforts to Strengthen the Administration of Mandatory Industrial Standards for Medical Devices | | 国家药监局综合司关于进一步加强医疗器械强制性行业标准管理有关事项的通知 |
| (No. 72 [2020] of the Department of General Affairs of the National Medical Products Administration) | | （药监综械注〔2020〕72号） |
| The medical products administrations of all provinces, autonomous regions, and municipalities directly under the Central Government; the Medical Products Administration of Xinjiang Production and Construction Corps; and all relevant entities: | | 各省、自治区、直辖市药品监督管理局，新疆生产建设兵团药品监督管理局，各有关单位： |
| For the purposes of further unifying the understanding of mandatory industrial standards, and effectively promoting the standardization and effective implementation of mandatory industrial standards for medical devices, in accordance with the Standardization Law of the People's Republic of China, the Regulation on the Supervision and Administration of Medical Devices, the Measures for the Administration of Mandatory National Standards, and the Measures for the Administration of the Standards for Medical Devices, the matters concerning further efforts to strengthen the administration of mandatory industrial standards for medical devices are hereby notified as follows: | | 为进一步统一对强制性行业标准的认识，切实推进医疗器械强制性行业标准规范、有效实施，根据《中华人民共和国标准化法》《医疗器械监督管理条例》《强制性国家标准管理办法》和《医疗器械标准管理办法》，现就进一步加强医疗器械强制性行业标准管理有关事项通知如下： |
| I. Effectively maintaining the legal status of mandatory industrial standards | | 一、切实维护强制性行业标准的法律地位 |
Mandatory industrial standards for medical devices mean unified technical requirements that are developed, revised, approved and issued by the National Medical Products Administration (“NMPA”) and that are followed in the research and development, production, operation, use, supervision and administration of medical devices. According to Article 10 of the Standardization Law of the People's Republic of China, “if any law, administrative regulation or decision of the State Council provides otherwise for the development of mandatory standards, such provisions shall prevail”. According to Article 6
．．．．．． | | 医疗器械强制性行业标准是由国家药监局组织制修订、批准发布，在医疗器械研制、生产、经营、使用及其监督管理活动中遵循的统一技术要求。《中华人民共和国标准化法》第十条规定“法律、行政法规和国务院决定对强制性标准的制定另有规定的，从其规定。”《医疗器械监督管理条例》第六条规定“医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。”各有关单位要充分认识强制性行业标准的法律地位，切实维护强制性行业标准的权威性，确保强制性行业标准规范、有效实施。
．．．．．． |
|
Dear visitor, as a premium member of this database, you will get complete access to all content.Please go premium and get more.
1. To become a premium member, please call 400-810-8266 Ext. 171.
2. Binding to the account with access to this database.
3. Apply for a trial account.
4. To get instant access to a document, you can Pay Amount 【￥300.00】 for your single purchase. | |
您好：您现在要进入的是北大法宝英文库会员专区。
如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户；您可通过网上支付进行单篇购买，支付成功后即可立即查看本篇内容。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail:info@chinalawinfo.com
|
| | | | | | | | |
Scan QR Code and Read on Mobile
|
|
|
|
|
|
Message: Please kindly comment on the present translation.
|
|
|
|
|
|
|
|
|
Translations are by lawinfochina.com, and we retain exclusive copyright over content
found on our website except for content we publish as authorized by respective copyright
owners or content that is publicly available from government sources.
Due to differences in language, legal systems, and culture, English translations
of Chinese law are for reference purposes only. Please use the official Chinese-language
versions as the final authority. Lawinfochina.com and its staff will not be directly
or indirectly liable for use of materials found on this website.
We welcome your comments and suggestions, which assist us in continuing to improve
the quality of our materials as we dynamically expand content.
|
|
|
|
|
|