Chinanews.com, April 2. According to news from the Ministry of Commerce website, on March 31, the Ministry of Commerce, in conjunction with the General Administration of Customs and the Drug Administration, issued the "Announcement on the Orderly Development of Medical Materials Export (No. 5 of 2020)." In response to questions from reporters such as the "Why an orderly launch of an orderly export of medical supplies and strengthen quality supervision" and other reporters were asked, the responsible comrades of the relevant departments of the three departments responded intensively.
The picture shows the workers in Fujian Kangbo Medical Technology Co., Ltd. making medical protective clothing on March 30. Photo by China News Agency reporter Zhang Jinchuan
The following is the full text of the Q & A:
1. Under the current situation, why should the three departments issue an announcement on orderly export of medical supplies and strengthen quality supervision? What considerations?
With the rapid spread of the new crown pneumonia epidemic around the world, many countries are facing severe challenges, and we share this. Epidemic prevention knows no boundaries, and fighting the epidemic requires the international community to work together and respond together.
Under the personal command and deployment of President Xi Jinping, and through the hard work of the people across the country, the situation of epidemic prevention and control in China has continued to improve. While continuing to do a good job in domestic epidemic prevention and control, we have actively deepened international cooperation in epidemic prevention and control and strived to serve the international community Provide support and help within your ability. This is not only an important measure to give back to the international community's support for China's fight against the epidemic, but also to actively support the global fight against the epidemic and build a community with a shared future for mankind.
The quality and safety of medical supplies are directly related to human life and health. The Chinese government has always attached great importance to the quality and safety of medical supplies and implemented strict management of related products. In the special period of epidemic prevention and control, it is particularly important to further strengthen quality supervision and regulate export order. According to the deployment of the Party Central Committee and the State Council, the Ministry of Commerce, in conjunction with the General Administration of Customs and the Drug Administration, issued an announcement on March 31, requiring export of testing reagents, medical masks, medical protective clothing, ventilator, infrared thermometers and other five categories of products must obtain the state Relevant qualifications of the drug regulatory authorities are in compliance with the quality standards of the importing country (region). If there is a quality problem in the export of medical supplies, we will carefully investigate with the relevant departments and find out that they will be investigated and punished together, punished in accordance with the law, and will not be tolerated, and the important role of medical supplies will be better exerted.
At the same time, we hope that foreign purchasers will choose suppliers of products registered with China's drug regulatory authorities, and conduct corresponding quality inspections before using the products, and use them in strict accordance with the applicable scope of products and operating procedures. If there are related problems in procurement and use, it is recommended that the companies of the two sides properly negotiate and solve them according to the principle of commercialization. We are willing to work with the international community to create a good environment for the orderly export of medical supplies and better support the global fight against the epidemic.
2. Can medical products be exported if they have not obtained the registration certificate of China's drug regulatory authority, but have obtained certification from relevant foreign standards?
According to the announcement, the export of related medical materials should obtain China's medical device product registration certificate, which meets the quality standards of the importing country (region). Regarding the situation that has obtained the certification of relevant foreign standards, but has not yet obtained China's medical device product registration certificate, it is recommended that relevant enterprises apply to the drug regulatory department in accordance with regulations. It should be noted that the registration information of China's related medical device products announced in this announcement is as of March 31, 2020, and the SFDA will dynamically update the relevant information. For inquiries, please log on the official website of the SFDA (www.nmpa. gov.cn/WS04/CL2582/).
3. After the announcement, what measures has the Customs taken to complete the export clearance of medical supplies?
At present, the new crown pneumonia outbreak has spread in many countries around the world. Doing a good job in exporting medical supplies is an important measure to actively support relevant countries in fighting the epidemic and deepening international cooperation in epidemic prevention and control. Under the unified leadership of the joint prevention and control mechanism of the State Council, on March 31, the Ministry of Commerce, the General Administration of Customs and the State Drug Administration jointly issued an announcement to support the guidance of domestic qualified enterprises to export medical supplies in an orderly manner in accordance with the principles of marketization To effectively maintain the order of the medical materials export market and establish a good image. In order to promote the implementation of the work, the General Administration of Customs established a special working group to strengthen the organizational leadership of medical materials export work, strengthen supervision and optimization services, strictly follow the list of qualified enterprises for export medical materials determined by relevant departments, and supervise inspection and release according to law; strengthen intellectual property rights Customs protection, severely cracking down on illegal export of infringing medical devices, masks and other epidemic prevention products; supporting enterprises to fill in relevant certificates by electronic means; and improving the accuracy and effectiveness of inspection operations. In addition, the customs also actively resolves problems and difficulties encountered in the customs clearance process of enterprises through various channels such as the 12360 customs hotline, provides better services to qualified enterprises, and supports the international community in fighting the epidemic.
According to statistics, since March 1, the country has inspected and released 2.77 billion pieces of major prevention and control materials such as export masks and protective clothing, valued at 6.29 billion yuan.
4. After the publication of the Announcement, what are the changes in customs procedures?
Prior to the publication of the Announcement, the enterprise applied for export, medical masks, medical protective clothing, ventilator, new coronavirus detection reagents, and infrared temperature timer. The accompanying documents may not be provided. The customs does not have the supervision port inspection requirements. It is necessary to submit documents such as invoices and packing lists.
After the publication of the "Announcement", when the enterprise declares to export the above five kinds of medical supplies, it is necessary to provide a written or electronic declaration of the medical supplies for export listed in the "Announcement" and a medical device product registration certificate at the customs clearance stage. The customs shall inspect and release the medical device product registration certificate approved by the drug regulatory department.
The Customs will continue to strengthen supervision and optimization services, support qualified enterprises to expand exports, support the international community to jointly prevent and control epidemics, and remind enterprises to strictly control product quality, adhere to integrity and compliance operations, and prepare relevant documents in advance when exporting.
Domestic approval of five or five types of export anti-epidemic materials
After the outbreak of the new crown pneumonia epidemic, the State Food and Drug Administration attached great importance to promptly launching emergency approval procedures for medical devices, and required provincial drug regulatory authorities to actively initiate emergency approval of second-class medical devices in their jurisdictions while strengthening product quality supervision. Drug regulatory authorities at all levels follow the principles of “unified command, early intervention, follow-up review, scientific approval” for products such as new crown virus detection reagents, medical masks, and medical protective clothing, as well as requirements to ensure product safety, effectiveness, and controllable quality , Innovate the review method, carry out registration inspection, quality system verification, registration data review in parallel, and speed up the review and approval process.
As of March 31, 2020, the State Food and Drug Administration has approved 25 new coronavirus detection reagents, including 17 nucleic acid detection reagents and 8 antibody detection reagents. Among them, due to its methodological characteristics, the antibody detection reagent product is only used as a supplementary detection for suspected cases of negative coronavirus nucleic acid detection, or used in conjunction with nucleic acid detection in the diagnosis of suspected cases, and is not used as a basis for the diagnosis and exclusion of patients with coronavirus It also does not apply to screening for the general population. Antibody detection reagents are for medical institutions only.
In addition, the State Drug Administration and the provincial drug regulatory authorities also approved 67 domestic ventilator product registration certificates, 302 domestic medical protective clothing product registration certificates, 153 domestic medical protective mask product registration certificates, and domestic medical surgical mask product registrations. Certificate 549, 785 domestic registration certificates for disposable medical mask products, 234 domestic registration certificates for infrared thermometers (including ear thermometers, forehead guns). Relevant registration approval information can be found on the website of the State Drug Administration.
6. After the announcement, has the drug regulatory department continued to issue the "Export Sales Certificate for Medical Device Products"?
The quality of exported medical devices is monitored by the importing country in accordance with international practice. Article 44 of China's "Regulations on the Supervision and Administration of Medical Devices" clearly states: "Enterprises that export medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region)."
In the process of exporting medical device products, some importing countries (regions) sometimes require enterprises that export medical devices to provide sales certificates 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 issues export sales certificates based on the needs of the enterprises. Such sales certificates are service matters, not licensing matters, and have no direct relationship with product clearance.
In order to regulate the issuance of medical device export sales certificates, in June 2015, the State Drug Administration issued the “Administrative Regulations on Medical Device Product Export Sales Certificates”, which stipulates that China has obtained medical device product registration certificates and production licenses, or Where medical device product filing and production filing have been completed, the drug regulatory department may issue a "Medical Device Product Export Sales Certificate" for the relevant manufacturing enterprise. At the same time, it is clear that enterprises should ensure that the products they export meet the relevant requirements for export of medical devices, and they must meet the relevant requirements of importing countries.
Manufacturers exporting medical devices may submit the "Registration Form for Medical Device Product Export Sales Certificates" and business licenses, medical device production licenses or filing certificates, and medical device product registration certificates to the provincial drug regulatory department or its designated department. Or a copy of the record voucher and other materials, apply for "Certificate of Medical Device Product Export Sales".
It is clear in the joint announcement that the customs shall inspect and release the medical device product registration certificate approved by the drug regulatory department. After the announcement, if the company raises a demand, the drug regulatory department will continue to issue "Medical Device Product Export Sales Certificate" to the company to provide related services in accordance with the "Administrative Regulations on Medical Device Product Export Sales Certificate". Here again it is emphasized that the joint announcement of the three departments stipulates that the customs shall check and release on the basis of the medical device product registration certificate approved by the drug regulatory department, not on the basis of the export sales certificate.