國家藥品監督管理局發(fā)布《中國對新型冠狀病毒檢測試劑和防護用品的監管要求及標準》

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來(lái)源：中國醫藥保健品進(jìn)出口商會(huì )

2020-04-01

3月30日，國家藥品監督管理局發(fā)布《中國對新型冠狀病毒檢測試劑和防護用品的監管要求及標準》，主要包括新型冠狀病毒檢測試劑注冊管理相關(guān)要求、防護用品監管要求、防護用品標準、加強醫用防護用品 ...

3月30日，國家藥品監督管理局發(fā)布《中國對新型冠狀病毒檢測試劑和防護用品的監管要求及標準》，主要包括新型冠狀病毒檢測試劑注冊管理相關(guān)要求、防護用品監管要求、防護用品標準、加強醫用防護用品（口罩、防護服、護目鏡、面罩）監管、加強應急審批新冠肺炎病毒檢測試劑上市后監管等內容。

為規范病毒檢測試劑盒和防護用品市場(chǎng)秩序，對醫療防疫物資商業(yè)采購提供指引，幫助國內外供需雙方進(jìn)行有效對接，現全文轉發(fā)國家藥品監督管理局《中國對新型冠狀病毒檢測試劑和防護用品的監管要求及標準》（中、英文），供參考。

附：《中國對新型冠狀病毒檢測試劑和防護用品的監管要求及標準》

中國醫藥保健品進(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：

中國對新型冠狀病毒檢測試劑和防護用品的監管要求及標準

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療器械按照風(fēng)險程度劃分為第一類(lèi)、第二類(lèi)、第三類(lèi)管理。第一類(lèi)風(fēng)險程度最低，第三類(lèi)風(fēng)險程度最高。新型冠狀病毒檢測試劑作為第三類(lèi)醫療器械管理。

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)工藝及反應體系的研究資料，6.分析性能評估資料，7.陽(yáng)性判斷值或參考區間確定資料，8.穩定性研究資料，9.生產(chǎn)及自檢記錄，10.臨床評價(jià)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(shuō)明書(shū)，15.標簽樣稿,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.

為應對新冠肺炎疫情，國家藥監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(diǎn)》《2019新型冠狀病毒抗原抗體檢測試劑注冊技術(shù)審評要點(diǎn)（試行）》，指導企業(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，國家藥品監督管理局應急審批批準23個(gè)新冠病毒檢測試劑，其中包括15個(gè)核酸檢測試劑，8個(gè)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、防護用品監管要求

中國國家藥品監督管理局已經(jīng)發(fā)布醫用口罩、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(lèi)產(chǎn)品等防控疫情相關(guān)產(chǎn)品的技術(shù)審查指導原則。

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、防護用品標準

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

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、加強醫用防護用品（口罩、防護服、護目鏡、面罩）監管

中國將醫用口罩、醫用防護服作為二類(lèi)醫療器械進(jìn)行管理，按照我國《醫療器械監督管理條例》和《醫療器械生產(chǎn)監督管理辦法》的有關(guān)規定，其生產(chǎn)企業(yè)需獲得省級藥監部門(mén)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.

中國將護目鏡、面罩作為一類(lèi)醫療器械進(jìn)行管理，其生產(chǎn)企業(yè)需向設區的市級負責藥品監管的部門(mén)辦理一類(lèi)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)均要按照中國醫療器械生產(chǎn)管理規范的要求，建立健全與所生產(chǎn)醫療器械相適應的質(zhì)量管理體系并保證其有效運行；嚴格按照經(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(chǎng)的醫療器械符合強制性標準以及經(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(wú)菌醫療器械產(chǎn)品，除要求其質(zhì)量體系符合《醫療器械生產(chǎn)質(zhì)量管理規范》的要求外，還應符合中國《醫療器械生產(chǎn)質(zhì)量管理規范無(wú)菌醫療器械附錄》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部門(mén)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、加強應急審批新冠肺炎病毒檢測試劑上市后監管

結合注冊審批進(jìn)展，及時(shí)要求相關(guān)省局切實(shí)加強對應急審批新冠肺炎病毒檢測試劑生產(chǎn)企業(yè)的監督檢查，監督企業(yè)嚴格落實(shí)主體責任，認真履行有關(guān)規定要求，嚴格按照產(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，認真開(kāi)展不良事件監測，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試劑注冊技術(shù)審評要點(diǎn)

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(diǎn)（試行）

3.已批準新型冠狀病毒核酸檢測試劑列表

4.醫用口罩產(chǎn)品注冊技術(shù)審查指導原則

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

6.一次性使用無(wú)菌手術(shù)包類(lèi)產(chǎn)品注冊技術(shù)審查指導原則

7.GB19082-2009《醫用一次性防護服技術(shù)要求》

8.GB19083-2010《醫用防護口罩技術(shù)要求》

9.YY/T0969-2013《一次性使用醫用口罩》

10.YY0469-2011《醫用外科口罩》