國(guó)家藥品監(jiān)督管理局發(fā)布《中國(guó)對(duì)新型冠狀病毒檢測(cè)試劑和防護(hù)用品的監(jiān)管要求及標(biāo)準(zhǔn)》

熱門推薦：國(guó)家藥品監(jiān)督管理局 , 中國(guó)對(duì)新型冠狀病毒檢測(cè)試劑和防護(hù)用品的監(jiān)管要求及標(biāo)準(zhǔn) ,

來(lái)源：中國(guó)醫(yī)藥保健品進(jìn)出口商會(huì)

2020-04-01

3月30日，國(guó)家藥品監(jiān)督管理局發(fā)布《中國(guó)對(duì)新型冠狀病毒檢測(cè)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(cè)試劑注冊(cè)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(qiáng)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(qiáng)應(yīng)急審批新冠肺炎病毒檢測(cè)試劑上市后監(jiān)管等內(nèi)容。

為規(guī)范病毒檢測(cè)試劑盒和防護(hù)用品市場(chǎng)秩序，對(duì)醫(yī)療防疫物資商業(yè)采購(gòu)提供指引，幫助國(guó)內(nèi)外供需雙方進(jìn)行有效對(duì)接，現(xiàn)全文轉(zhuǎn)發(fā)國(guó)家藥品監(jiān)督管理局《中國(guó)對(duì)新型冠狀病毒檢測(cè)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(guó)對(duì)新型冠狀病毒檢測(cè)試劑和防護(hù)用品的監(jiān)管要求及標(biāo)準(zhǔn)》

中國(guó)醫(yī)藥保健品進(jìn)出口商會(huì)

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(guó)對(duì)新型冠狀病毒檢測(cè)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(cè)試劑注冊(cè)管理相關(guān)要求

中國(guó)對(duì)于包括體外診斷試劑的醫(yī)療器械按照風(fēng)險(xiǎn)程度劃分為第一類、第二類、第三類管理。第一類風(fēng)險(xiǎn)程度最低，第三類風(fēng)險(xiǎn)程度最高。新型冠狀病毒檢測(cè)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(qǐng)新型冠狀病毒檢測(cè)試劑注冊(cè)，提交以下申報(bào)資料：1.申請(qǐng)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(píng)估資料，7.陽(yáng)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(píng)價(jià)資料，11.產(chǎn)品風(fēng)險(xiǎn)分析資料，12.產(chǎn)品技術(shù)要求，13.產(chǎn)品注冊(cè)檢驗(yàn)報(bào)告，14.產(chǎn)品說(shuō)明書(shū)，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(duì)新冠肺炎疫情，國(guó)家藥監(jiān)局器械審評(píng)中心制定了《2019新型冠狀病毒核酸檢測(cè)試劑注冊(cè)技術(shù)審評(píng)要點(diǎn)》《2019新型冠狀病毒抗原抗體檢測(cè)試劑注冊(cè)技術(shù)審評(píng)要點(diǎn)（試行）》，指導(dǎo)企業(yè)進(jìn)行注冊(cè)申報(bào)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(guó)家藥品監(jiān)督管理局應(yīng)急審批批準(zhǔn)23個(gè)新冠病毒檢測(cè)試劑，其中包括15個(gè)核酸檢測(cè)試劑，8個(gè)抗體檢測(cè)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(guó)國(guó)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(wú)菌手術(shù)衣、一次性使用無(wú)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(guó)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(qiáng)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(guó)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(guó)《醫(yī)療器械監(jiān)督管理?xiàng)l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(jí)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(guó)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(jí)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(guó)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(yùn)行；嚴(yán)格按照經(jīng)注冊(cè)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(qiáng)制性標(biāo)準(zhǔn)以及經(jīng)注冊(cè)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(duì)于無(wú)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(guó)《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范無(wú)菌醫(yī)療器械附錄》的相關(guān)要求。生產(chǎn)企業(yè)定期對(duì)質(zhì)量管理體系的運(yùn)行情況進(jìn)行自查，并向所在地省級(jí)藥監(jiān)部門提交自查報(bào)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(qiáng)應(yīng)急審批新冠肺炎病毒檢測(cè)試劑上市后監(jiān)管

結(jié)合注冊(cè)審批進(jìn)展，及時(shí)要求相關(guān)省局切實(shí)加強(qiáng)對(duì)應(yīng)急審批新冠肺炎病毒檢測(cè)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(shí)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(yùn)行，認(rèn)真開(kāi)展不良事件監(jiān)測(cè)，及時(shí)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(cè)試劑注冊(cè)技術(shù)審評(píng)要點(diǎn)

2.2019新型冠狀病毒抗原抗體檢測(cè)試劑注冊(cè)技術(shù)審評(píng)要點(diǎn)（試行）

3.已批準(zhǔn)新型冠狀病毒核酸檢測(cè)試劑列表

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

5.一次性使用無(wú)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(wú)菌手術(shù)包類產(chǎn)品注冊(cè)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》