3月30日，國家藥品監(jiān)督管理局發(fā)布《中國對新型冠狀病毒檢測試劑和防護(hù)用品的監(jiān)管要求及標(biāo)準(zhǔn)》，主要包括新型冠狀病毒檢測試劑注冊管理相關(guān)要求、防護(hù)用品監(jiān)管要求、防護(hù)用品標(biāo)準(zhǔn)、加強醫(yī)用防護(hù)用品（口罩、防護(hù)服、護(hù)目鏡、面罩）監(jiān)管、加強應(yīng)急審批新冠肺炎病毒檢測試劑上市后監(jiān)管等內(nèi)容。

       為規(guī)范病毒檢測試劑盒和防護(hù)用品市場秩序，對醫(yī)療防疫物資商業(yè)采購提供指引，幫助國內(nèi)外供需雙方進(jìn)行有效對接，現(xiàn)全文轉(zhuǎn)發(fā)國家藥品監(jiān)督管理局《中國對新型冠狀病毒檢測試劑和防護(hù)用品的監(jiān)管要求及標(biāo)準(zhǔn)》（中、英文），供參考。

       附：《中國對新型冠狀病毒檢測試劑和防護(hù)用品的監(jiān)管要求及標(biāo)準(zhǔn)》

       中國醫(yī)藥保健品進(jìn)出口商會

       2020年3月31日

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

       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).

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

       China Chamber of Commerce for Import & Export of Medicines & Health Products

       March, 31,2020

       附：

       中國對新型冠狀病毒檢測試劑和防護(hù)用品的監(jiān)管要求及標(biāo)準(zhǔn)

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

       一、新型冠狀病毒檢測試劑注冊管理相關(guān)要求

       中國對于包括體外診斷試劑的醫(yī)療器械按照風(fēng)險程度劃分為第一類、第二類、第三類管理。第一類風(fēng)險程度最低，第三類風(fēng)險程度最高。新型冠狀病毒檢測試劑作為第三類醫(yī)療器械管理。

       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.

       企業(yè)申請新型冠狀病毒檢測試劑注冊，提交以下申報資料：1.申請表，2.證明性文件，3.綜述資料，4.主要原材料的研究資料，5.主要生產(chǎn)工藝及反應(yīng)體系的研究資料，6.分析性能評估資料，7.陽性判斷值或參考區(qū)間確定資料，8.穩(wěn)定性研究資料，9.生產(chǎn)及自檢記錄，10.臨床評價資料，11.產(chǎn)品風(fēng)險分析資料，12.產(chǎn)品技術(shù)要求，13.產(chǎn)品注冊檢驗報告，14.產(chǎn)品說明書，15.標(biāo)簽樣稿,16.符合性聲明。

       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.

       為應(yīng)對新冠肺炎疫情，國家藥監(jiān)局器械審評中心制定了《2019新型冠狀病毒核酸檢測試劑注冊技術(shù)審評要點》《2019新型冠狀病毒抗原抗體檢測試劑注冊技術(shù)審評要點（試行）》，指導(dǎo)企業(yè)進(jìn)行注冊申報工作。

       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，國家藥品監(jiān)督管理局應(yīng)急審批批準(zhǔn)23個新冠病毒檢測試劑，其中包括15個核酸檢測試劑，8個抗體檢測試劑。

       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、防護(hù)用品監(jiān)管要求

       中國國家藥品監(jiān)督管理局已經(jīng)發(fā)布醫(yī)用口罩、一次性使用無菌手術(shù)衣、一次性使用無菌手術(shù)包類產(chǎn)品等防控疫情相關(guān)產(chǎn)品的技術(shù)審查指導(dǎo)原則。

       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、防護(hù)用品標(biāo)準(zhǔn)

       中國制定發(fā)布了醫(yī)用防護(hù)服、醫(yī)用口罩的相關(guān)標(biāo)準(zhǔn)，分別為GB19082-2009《醫(yī)用一次性防護(hù)服技術(shù)要求》、GB19083-2010《醫(yī)用防護(hù)口罩技術(shù)要求》，YY/T0969-2013《一次性使用醫(yī)用口罩》和YY0469-2011《醫(yī)用外科口罩》標(biāo)準(zhǔn)。

       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、加強醫(yī)用防護(hù)用品（口罩、防護(hù)服、護(hù)目鏡、面罩）監(jiān)管

       中國將醫(yī)用口罩、醫(yī)用防護(hù)服作為二類醫(yī)療器械進(jìn)行管理，按照我國《醫(yī)療器械監(jiān)督管理條例》和《醫(yī)療器械生產(chǎn)監(jiān)督管理辦法》的有關(guān)規(guī)定，其生產(chǎn)企業(yè)需獲得省級藥監(jiān)部門發(fā)放的生產(chǎn)許可證件后方可生產(chǎn)。

       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.

       中國將護(hù)目鏡、面罩作為一類醫(yī)療器械進(jìn)行管理，其生產(chǎn)企業(yè)需向設(shè)區(qū)的市級負(fù)責(zé)藥品監(jiān)管的部門辦理一類生產(chǎn)備案后方可生產(chǎn)。

       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.

       生產(chǎn)企業(yè)均要按照中國醫(yī)療器械生產(chǎn)管理規(guī)范的要求，建立健全與所生產(chǎn)醫(yī)療器械相適應(yīng)的質(zhì)量管理體系并保證其有效運行；嚴(yán)格按照經(jīng)注冊或者備案的產(chǎn)品技術(shù)要求組織生產(chǎn)，保證出廠的醫(yī)療器械符合強制性標(biāo)準(zhǔn)以及經(jīng)注冊或者備案的產(chǎn)品技術(shù)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.

       對于無菌醫(yī)療器械產(chǎn)品，除要求其質(zhì)量體系符合《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》的要求外，還應(yīng)符合中國《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范無菌醫(yī)療器械附錄》的相關(guān)要求。生產(chǎn)企業(yè)定期對質(zhì)量管理體系的運行情況進(jìn)行自查，并向所在地省級藥監(jiān)部門提交自查報告。

       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、加強應(yīng)急審批新冠肺炎病毒檢測試劑上市后監(jiān)管

       結(jié)合注冊審批進(jìn)展，及時要求相關(guān)省局切實加強對應(yīng)急審批新冠肺炎病毒檢測試劑生產(chǎn)企業(yè)的監(jiān)督檢查，監(jiān)督企業(yè)嚴(yán)格落實主體責(zé)任，認(rèn)真履行有關(guān)規(guī)定要求，嚴(yán)格按照產(chǎn)品技術(shù)要求組織生產(chǎn)，保證質(zhì)量管理體系有效運行，認(rèn)真開展不良事件監(jiān)測，及時跟蹤產(chǎn)品使用情況，確保產(chǎn)品質(zhì)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.

       相關(guān)文件：

       1.2019新型冠狀病毒核酸檢測試劑注冊技術(shù)審評要點

       2.2019新型冠狀病毒抗原抗體檢測試劑注冊技術(shù)審評要點（試行）

       3.已批準(zhǔn)新型冠狀病毒核酸檢測試劑列表

       4.醫(yī)用口罩產(chǎn)品注冊技術(shù)審查指導(dǎo)原則

       5.一次性使用無菌手術(shù)衣產(chǎn)品技術(shù)審查指導(dǎo)原則

       6.一次性使用無菌手術(shù)包類產(chǎn)品注冊技術(shù)審查指導(dǎo)原則

       7.GB19082-2009《醫(yī)用一次性防護(hù)服技術(shù)要求》

       8.GB19083-2010《醫(yī)用防護(hù)口罩技術(shù)要求》

       9.YY/T0969-2013《一次性使用醫(yī)用口罩》

       10.YY0469-2011《醫(yī)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.）

       原文及英文譯文請查詢國家藥品監(jiān)督管理局網(wǎng)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或http://english.nmpa.gov.cn/2020-03/30/c_467202.htm