国家药品监督管理局发布《中国对新型冠状病毒检测试剂和防护用品的监管要求及标准》

3月30日，国家药品监督管理局发布《中国对新型冠状病毒检测试剂和防护用品的监管要求及标准》，主要包括新型冠状病毒检测试剂注册管理相关要求、防护用品监管要求、防护用品标准、加强医用防护用品（口罩、防护服、护目镜、面罩）监管、加强应急审批新冠肺炎病毒检测试剂上市后监管等内容。 

为规范病毒检测试剂盒和防护用品市场秩序，对医疗防疫物资商业采购提供指引，帮助国内外供需双方进行有效对接，现全文转发国家药品监督管理局《中国对新型冠状病毒检测试剂和防护用品的监管要求及标准》（中、英文），供参考。

中国医药保健品进出口商会

2020年3月31日

   On March 30, NMPA released the Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective Equipment in China, which covers registration requirements of Reagent Test Kits, regulatory requirements and standards for protective equipment, enhancing regulation on medical protective equipment(face masks, protective clothing, goggles and face shields), strengthening post-market surveillance of coronavirus reagent test kits via emergency approval, etc.

  To ensure market order of Coronavirus Reagent Test Kits and Protective Equipment, guide commercial purchase of medical protective products, and support effective linkage between demand and supply side, please refer to the below full text of Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective Equipment in China(Chinese and English Versions).

CCCMHPIE

March, 31,2020

中国对新型冠状病毒检测试剂和防护用品的

监管要求及标准

Regulatory Requirements and Standards for Coronavirus Reagent Test Kits and Protective Equipment in China

一、新型冠状病毒检测试剂注册管理相关要求

中国对于包括体外诊断试剂的医疗器械按照风险程度划分为第一类、第二类、第三类管理。第一类风险程度最低，第三类风险程度最高。新型冠状病毒检测试剂作为第三类医疗器械管理。

I. Requirements for registration of coronavirus reagent test kits 

China classifies medical devices including in vitro diagnostic reagents into three categories according to risk levels. Class I has the lowest level of risk and Class III has the highest. Coronavirus reagent test kits are classified as Class III medical devices.

企业申请新型冠状病毒检测试剂注册，提交以下申报资料：1.申请表，2.证明性文件，3.综述资料，4.主要原材料的研究资料，5.主要生产工艺及反应体系的研究资料，6.分析性能评估资料，7.阳性判断值或参考区间确定资料，8.稳定性研究资料，9.生产及自检记录，10.临床评价资料，11.产品风险分析资料，12.产品技术要求，13.产品注册检验报告，14.产品说明书，15.标签样稿,16.符合性声明。

Enterprises applying for registration of coronavirus reagent test kits must submit the following materials:

1. Application forms;

2. Qualification documents;

3. General materials;

4. Research materials for major raw materials;

5. Research materials for major production techniques and reaction systems;

6. Evaluation materials of performance analysis;

7. Materials for determination of positive value or reference range determination; 

8. Stability research materials;

9. Production and self-testing records;

10. Clinical evaluation materials;

11. Materials on analysis of product risks;

12. Technical requirements of products;

13. Product registration and testing reports;

14. Product instructions;

15. Labeling samples;

16. Declaration of conformity.

为应对新冠肺炎疫情，国家药监局器械审评中心制定了《2019新型冠状病毒核酸检测试剂注册技术审评要点》《2019新型冠状病毒抗原抗体检测试剂注册技术审评要点（试行）》，指导企业进行注册申报工作。

In response to the coronavirus epidemic, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) has formulated the Technical Key Points for Coronavirus (COVID-19) Nucleic Acid Reagent Test Kit Registration Review and the Technical Key Points for Coronavirus (COVID-19) Antigen-antibody Detection Reagent Registration Review (Trial). The documents were prepared to guide enterprises in registration application.

截至2020年3月30日，国家药品监督管理局应急审批批准23个新冠病毒检测试剂，其中包括15个核酸检测试剂，8个抗体检测试剂。

As of March 30, 2020, the NMPA had approved 23 coronavirus test kits in response to the emergency, including 15 nucleic acid reagent test kits and 8 antibody test kits.

二、防护用品监管要求

中国国家药品监督管理局已经发布医用口罩、一次性使用无菌手术衣、一次性使用无菌手术包类产品等防控疫情相关产品的技术审查指导原则。

II. Regulatory requirements for protective equipment

The NMPA has issued guidelines for technical review of products related to epidemic prevention and control including medical face masks, single-use surgical gowns and single-use surgical packs.

三、防护用品标准

中国制定发布了医用防护服、医用口罩的相关标准，分别为GB19082-2009《医用一次性防护服技术要求》、GB19083-2010《医用防护口罩技术要求》，YY/T0969-2013《一次性使用医用口罩》和YY0469-2011《医用外科口罩》标准。

III. Standards for protective equipment 

China has formulated and issued the following standards for medical protective clothing and medical face masks: GB19082-2009 Technical Requirements for Single-use Protective Clothing for Medical Use, GB19083-2010 Technical Requirements for Protective Face Masks for Medical Use, YY/T0969-2013 Single-use Medical Face Mask and YY0469-2011 Surgical Masks.

四、加强医用防护用品（口罩、防护服、护目镜、面罩）监管

中国将医用口罩、医用防护服作为二类医疗器械进行管理，按照我国《医疗器械监督管理条例》和《医疗器械生产监督管理办法》的有关规定，其生产企业需获得省级药监部门发放的生产许可证件后方可生产。

IV. Enhance regulation of medical protective equipment (masks, protective clothing, goggles and face shields)

Medical masks and protective clothing are regulated according to the standards for Class II medical devices in China. According to relevant sections of China's Regulations for the Supervision and Administration of Medical Devices and the Provisions for the Supervision and Administration of Medical Device Manufacturing, a manufacturing enterprise must obtain production licenses issued by a provincial drug regulatory department before production. 

中国将护目镜、面罩作为一类医疗器械进行管理，其生产企业需向设区的市级负责药品监管的部门办理一类生产备案后方可生产。

Goggles and face shields are regulated according to the standards for Class I medical devices in China. A manufacturing enterprise must file the records with a drug regulatory department at districted city level before production. 

生产企业均要按照中国医疗器械生产管理规范的要求，建立健全与所生产医疗器械相适应的质量管理体系并保证其有效运行；严格按照经注册或者备案的产品技术要求组织生产，保证出厂的医疗器械符合强制性标准以及经注册或者备案的产品技术要求。

Manufacturing enterprises must establish a quality management system for medical products and ensure its effective operation in accordance with the requirements of regulations on medical device manufacturing regulations in China. They must operate in strict accordance with the product technical requirements for products registered or filed for record and ensure that the medical devices manufactured meet the mandatory standards and product technical requirements for products registered or filed for record.

对于无菌医疗器械产品，除要求其质量体系符合《医疗器械生产质量管理规范》的要求外，还应符合中国《医疗器械生产质量管理规范无菌医疗器械附录》的相关要求。生产企业定期对质量管理体系的运行情况进行自查，并向所在地省级药监部门提交自查报告。

The quality system of aseptic medical device products shall not only meet the requirements of the Good Manufacturing Practice (GMP) for Medical Devices, but also the relevant requirements of China's Appendix for Aseptic Medical Device of Good Manufacturing Practice (GMP) for Medical Devices in China. Manufacturing enterprises shall regularly carry out self-inspection of the operation of their quality management systems, and submit self-inspection reports to the local drug regulatory departments.

五、加强应急审批新冠肺炎病毒检测试剂上市后监管

结合注册审批进展，及时要求相关省局切实加强对应急审批新冠肺炎病毒检测试剂生产企业的监督检查，监督企业严格落实主体责任，认真履行有关规定要求，严格按照产品技术要求组织生产，保证质量管理体系有效运行，认真开展不良事件监测，及时跟踪产品使用情况，确保产品质量安全。

V. Strengthen post-market surveillance of coronavirus reagent test kits that received emergency approval

The relevant provincial drug regulatory departments are required to strengthen supervision and inspection of the manufacturers of coronavirus reagent test kits based on the progress of registration review and approval. Manufacturing enterprises shall be urged to undertake the primary responsibilities by conscientiously fulfilling relevant requirements, carrying out production in strict accordance with the product technical requirements for products, and ensuring the effective operation of the quality management system. Manufacturers should also monitor any adverse events, track the use of the products, and ensure product quality and safety. 

相关文件：

1.2019新型冠状病毒核酸检测试剂注册技术审评要点

2.2019新型冠状病毒抗原抗体检测试剂注册技术审评要点（试行）

3.已批准新型冠状病毒核酸检测试剂列表

4.医用口罩产品注册技术审查指导原则

5.一次性使用无菌手术衣产品技术审查指导原则

6.一次性使用无菌手术包类产品注册技术审查指导原则

7.GB19082-2009《医用一次性防护服技术要求》

8.GB19083-2010《医用防护口罩技术要求》

9.YY/T0969-2013《一次性使用医用口罩》

10.YY0469-2011《医用外科口罩》

Related Documents (in Chinese):

1. Technical Key Points for Coronavirus (COVID-19) Nucleic Acid Reagent Test Kit for Registration Review

2. Technical Key Points for Coronavirus (COVID-19) Antigen-antibody Detection Reagent for Registration Review (Trial)

3. List of Approved Coronavirus Nucleic Acid Reagent Test Kits

4. Technical Guidelines for Medical Face Mask Product Registration Review

5. Technical Guidelines for Single-use Surgical Gown Review

6. Technical Guidelines for Single-use Surgical Pack Registration Review

7. GB19082-2009 Technical Requirements for Single-use Protective Clothing for Medical Use

8. GB19083-2010 Technical Requirements for Protective Face Masks for Medical Use

9. YY/T0969-2013 Single-use Medical Face Mask

10. YY0469-2011 Surgical Mask

（The English version is for reference only. In case of any discrepancy or ambiguity of meaning between this English translation and the Chinese version, the latter shall prevail.）

原文及英文译文请查询国家药品监督管理局网站：

Please visit the NMPA’s official website for the full text of the original version (in Chinese) and its English copy:

http://www.nmpa.gov.cn/WS04/CL2056/376161.html?WxUg5ztDmi=1585624726370

http://english.nmpa.gov.cn/2020-03/30/c_467202.htm