| Announcement of the National Medical Products Administration on Issuing the Rules for the Unique Identification System for Medical Devices | | 国家药监局关于发布医疗器械唯一标识系统规则的公告 |
| (Announcement No. 66 [2019] of the National Medical Products Administration) | | （国家药监局公告2019年第66号） |
| For purposes of implementing the Notice by the General Office of the State Council of Issuing the Reform Plan for the Control of High-value Medical Supplies (No. 37 [2019], General Office of the State Council), regulating the construction of the unique identification system for medical devices, and strengthening the whole life cycle management of medical devices, in accordance with the Regulation on the Supervision and Administration of Medical Devices, the National Medical Products Administration has developed the Rules for the Unique Identification System for Medical Devices, which are hereby issued and shall come into force on October 1, 2019. | | 为贯彻落实《国务院办公厅关于印发治理高值医用耗材改革方案的通知》（国办发〔2019〕37号），规范医疗器械唯一标识系统建设，加强医疗器械全生命周期管理，依据《医疗器械监督管理条例》，国家药监局制定了《医疗器械唯一标识系统规则》，现予发布，自2019年10月1日起施行。 |
| | 特此公告。 |
| Annex: Rules for the Unique Identification System for Medical Devices | | 附件：医疗器械唯一标识系统规则 |
| National Medical Products Administration | | 国家药监局 |
| August 23, 2019 | | 2019年8月23日 |
| Annex | | 附件 |
| Rules for the Unique Identification System for Medical Devices | | 医疗器械唯一标识系统规则 |
| Article 1 For purposes of regulating the construction of the unique identification system for medical devices and strengthening the whole life cycle management of medical devices, these Rules are developed in accordance with the Regulation on the Supervision and Administration of Medical Devices. | | 第一条 为规范医疗器械唯一标识系统建设，加强医疗器械全生命周期管理，根据《医疗器械监督管理条例》，制定本规则。 |
| Article 2 The unique identification system for medical devices sold and used within the territory of the People's Republic of China shall comply with these Rules. | | 第二条 在中华人民共和国境内销售、使用的医疗器械，其唯一标识系统应当符合本规则。 |
| Article 3 For the purpose of these Rules, the “unique identification system for medical devices” consists of the unique identification of medical devices, the unique identification data carrier and the unique identification database. | | 第三条 本规则所称医疗器械唯一标识系统，由医疗器械唯一标识、唯一标识数据载体和唯一标识数据库组成。 |
| The “unique identification of a medical device” means the code consisting of numbers, letters or symbols attached to the medical device product or its package, which is used to identify the uniqueness of the medical device. | | 医疗器械唯一标识，是指在医疗器械产品或者包装上附载的，由数字、字母或者符号组成的代码，用于对医疗器械进行唯一性识别。 |
| The “unique identification data carrier of medical devices” means the data media used to store or transmit the unique identification of medical devices. | | 医疗器械唯一标识数据载体，是指存储或者传输医疗器械唯一标识的数据媒介。 |
| The “unique identification database of medical devices” means a database that stores the product identifications of unique identifications of medical devices and associated information. | | 医疗器械唯一标识数据库，是指储存医疗器械唯一标识的产品标识与关联信息的数据库。 |
| Article 4 The construction of the unique identification system for medical devices shall actively refer to international standards and follow the principles of government guidance, enterprise implementation, overall promotion and step-by-step implementation. | | 第四条 医疗器械唯一标识系统建设应当积极借鉴国际标准，遵循政府引导、企业落实、统筹推进、分步实施的原则。 |
| Article 5 The National Medical Products Administration shall be responsible for establishing the unique identification system for medical devices, making plans for the construction of the unique identification system for medical devices, and promoting all parties' active application of the unique identification of medical devices so as to promote the whole life cycle management of medical devices. | | 第五条 国家药品监督管理局负责建立医疗器械唯一标识系统制度，制定医疗器械唯一标识系统建设规划，推动各方积极应用医疗器械唯一标识，促进医疗器械全生命周期管理。 |
The medical product administration of a province, autonomous region or municipality directly under the Central Government shall be responsible for directing and supervising the construction of the unique identification system for medical devices by registrants and recordation applicants within its administrative region.
．．．．．． | | 省、自治区、直辖市药品监督管理部门负责指导并监督本行政区域内注册人/备案人开展医疗器械唯一标识系统建设相关工作。
．．．．．． |
|
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
|
| | | |
| | | |