3month31day,Ministry of Commerce and General Administration of Customs Issued by the food and Drug Administration Announcement on orderly export of medical materials 2020Year5number .Responsible comrades of relevant departments and bureaus of the three departments answered reporters' questions on the relevant issues of the announcement.

one In the current situation,Why should the three departments introduce policies to orderly carry out the export of medical materials,Announcement on Strengthening Quality Supervision What are your considerations

With novel coronavirus pneumonia spread rapidly across the globe,Many countries are facing severe challenges,We feel it.Epidemic prevention without borders,Fighting the epidemic requires the cooperation of the international community Joint response.

*** Deploy yourself,Through the hard work of the people all over the country,The situation of epidemic prevention and control in China continued to improve,While continuing to do a good job in domestic epidemic prevention and control,We will actively deepen international cooperation in epidemic prevention and control,Strive to provide support and help to the international community within its capacity.This is to give back the international community's early support for China's anti epidemic,It also actively supports the global fight against the epidemic An important measure to build a community with a shared future for mankind.

The quality and safety of medical materials is directly related to people's life and health.The Chinese government has always attached great importance to the quality and safety of medical materials,Implement strict management of relevant products.In the special period of epidemic prevention and control,Further strengthen quality supervision Standardizing export order is particularly important.According to the Party Central Committee Deployment of the State Council,Ministry of Commerce and General Administration of Customs FDA in3month31Announcement issued on,Required test reagent for export surgical mask Medical protective clothing respirator Infrared thermometer, etc5Such products must obtain relevant qualifications from the national drug regulatory department,Compliance with importing country region Quality standard requirements.For example, there are quality problems in the export of medical materials,We will investigate carefully with relevant departments,Find together,Investigate and deal with together,Punish according to law,Never tolerate,Give better play to the important role of medical materials.

meanwhile,We hope that foreign purchasers will choose suppliers of products registered with China's drug regulatory authorities,And conduct corresponding quality inspection before use,Use it correctly in strict accordance with the product scope of application and operating procedures.If there are relevant problems in procurement and use,It is suggested that the enterprises of both parties should properly negotiate and solve the problem according to the principle of commercialization.We are willing to work together with the international community,Create a good environment for orderly export of medical materials,Better support the global fight against the epidemic.

two If the medical materials have not obtained the registration certificate from the drug regulatory department of our country,However, it has been certified by relevant foreign standards,Can export

According to the announcement,The export of relevant medical materials shall obtain the registration certificate of medical device products in China,Compliance with importing country region Quality standard requirements.It has obtained relevant foreign standard certification,However, China's medical device product registration certificate has not been obtained,It is suggested that relevant enterprises apply to the drug regulatory department according to regulations.It should be noted that,The registration information of relevant medical device products in China published in this announcement is as of2020year3month31day,The State Food and Drug Administration will dynamically update relevant information,For enquiries, please log in to the official website of the State Food and drug administration www.nmpa.gov.cn/WS04/CL2582/ .

three After the announcement,What measures has the customs taken to do a good job in the export clearance of medical materials

current,Outbreak of novel coronavirus pneumonia in many countries around the world.Do a good job in the export of medical materials,It is to actively support relevant countries in combating the epidemic Important measures to deepen international cooperation in epidemic prevention and control.Under the unified leadership of the joint prevention and control mechanism of the State Council,3month31day,Ministry of Commerce customs head office Joint announcement of the State Drug Administration,Support and guide domestic qualified enterprises to follow the principle of marketization,Carry out the export of medical materials in an orderly manner according to law,Earnestly maintain the order of the export market of medical materials,Establish a good image.To promote the implementation of the work,The General Administration of Customs has established a special working group,Strengthen the organization and leadership of the export of medical materials,Strengthen supervision and optimize services,Strictly follow the list of qualified enterprises exporting medical materials determined by relevant departments,Supervision and release according to law Strengthening Customs Protection of intellectual property rights,Severely crack down on the export of infringing medical devices Illegal acts of masks and other epidemic prevention commodities Support enterprises to fill in relevant certificates electronically Improve the accuracy and effectiveness of inspection operations.in addition,Customs also actively adopted12360Customs hotline and other channels,Timely solve the problems and difficulties encountered in the process of customs clearance,Provide better services for qualified enterprises,Support the international community to fight the epidemic.

according to the statistics,3month1Since the day,A total of export masks were inspected and released throughout the country Protective clothing and other main prevention and control materials27.7100 million pieces,value62.9RMB 100 million.

four stay Notice After release,What are the changes in enterprise customs clearance procedures

stay Notice Before release,Application for export of medical masks by enterprises Medical protective clothing respirator New Coronavirus test kit Infrared thermometer,Accompanying documents may not be provided,Customs inspection requirements for ports without regulatory certificates,Submit invoices if necessary during review Packing list and other documents.

Notice After release,Application for export of medical masks by enterprises Medical protective clothing respirator New Coronavirus test kit infrared thermometer 5Medical supplies,Compared with the previous customs clearance links, it is necessary to provide Notice Written or electronic declaration of exported medical materials listed in Medical device product registration certificate.The customs shall examine and release the medical device product registration certificate approved by the drug regulatory department.

The customs will continue to strengthen supervision and optimize services,Support qualified enterprises to expand exports,Support the international community to jointly prevent and control the epidemic,It also reminds enterprises to strictly control product quality,Adhere to integrity management Compliance operation,Prepare relevant documents in advance when exporting.

five Domestic approval of five categories of export epidemic prevention materials

After the outbreak of novel coronavirus pneumonia,The State Food and Drug Administration attaches great importance to it,Quickly start the emergency approval procedure for medical devices,It also requires all provincial drug regulatory departments to strengthen product quality supervision at the same time,Actively start the emergency approval of class II medical devices within the jurisdiction.Drug regulatory departments at all levels for COVID-19 test reagents surgical mask Medical protective clothing and other products according to Unified command Early intervention Trial on arrival Scientific approval Principle of,And ensure product safety Effective Requirements for controllable quality,Innovative review methods,Parallel registration inspection Quality system verification Registration data review,Make every effort to speed up the review and approval.

by2020year3month31day,State Food and drug administration emergency approval25A COVID-19 test kit,include17Nucleic acid detection reagent,8Antibody detection reagent.among,Antibody detection reagent products due to their methodological characteristics,The product is used only as a supplementary test for suspected cases of negative nucleic acid detection in COVID-19.,Or in combination with nucleic acid detection in the diagnosis of suspected cases,No basis for diagnosis and exclusion of COVID-19 infected persons,Nor is it suitable for screening in the general population.Antibody detection reagent is only available for medical institutions.

in addition,The State Food and Drug Administration and provincial drug regulatory departments also approved the registration certificate of domestic ventilator products67individual,Registration certificate of domestic medical protective clothing products302individual,Registration certificate of domestic medical protective mask products153individual,Registration certificate of domestic medical surgical mask products549,Registration certificate of domestic disposable medical mask products785individual,Domestic infrared thermometer Including ear thermometer forehead thermometer Product registration certificate234individual.Relevant registration and approval information can be queried on the website of the State Food and drug administration.

six After the announcement,Whether the drug regulatory department continues to issue Export sales certificate of medical device products

Quality of exported medical devices,According to international practice,Regulated by the importing country.our country Regulations on the supervision and administration of medical devices Article 44 clearly stipulates An enterprise exporting medical devices shall ensure that the exported medical devices meet the requirements of the importing country region Requirements.

In the process of exporting medical device products,Some importing countries region Sometimes an enterprise exporting medical devices is required to provide a sales certificate issued by the competent government department of the country where the enterprise is located.In order to serve the export of medical device manufacturers in China,The drug regulatory department shall issue the export sales certificate according to the needs of the enterprise,This sales certificate is a service matter,Not a licensing matter,It has no direct relationship with product customs clearance.

To standardize the issuance of export sales certificates of medical devices,2015year6month,The State Drug Administration issued Regulations on the administration of export sales certificates of medical device products ,It is stipulated that medical device product registration certificate and production license certificate have been obtained in China,Or have gone through the filing of medical device products and production,The drug regulatory department may issue a certificate for relevant production enterprises Export sales certificate of medical device products .Also clear,The enterprise shall ensure that the exported products meet the requirements of relevant provisions on the export of medical devices,And shall meet the relevant requirements of the importing country.

The manufacturer of exported medical devices may submit to the provincial drug regulatory department of the administrative region or its designated department Registration form of export sales certificate of medical device products And enterprise business license Medical device production license or filing certificate Copies of medical device product registration certificate or filing certificate, etc,handle Export sales certificate of medical device products .

It is clear in the joint announcement,The customs shall examine and release the medical devices on the strength of the registration certificate of medical devices approved by the drug regulatory department.After the announcement,If the enterprise puts forward the demand,The drug regulatory authorities will also Regulations on the administration of export sales certificates of medical device products ,Continue to issue certificates for enterprises Export sales certificate of medical device products ,Provide relevant services.Here again,It is stipulated in the joint announcement of the three departments,The customs shall examine and release the medical devices on the strength of the registration certificate of medical devices approved by the drug regulatory department,Not according to the export sales certificate.