On March 31, the Ministry of Commerce (MOFCOM), the General Administration of Customs (GAC) and the National Medical Products Administration (NMPA) jointly published the Announcement on the Orderly Export of Medical Supplies (No.5 2020). Officials in charge from the three ministries met with the press.

Q1. Why do MOFCOM, the GAC and the NMPA publish an announcement regarding the orderly export of medical supplies and more stringent regulation on quality in the current situation? What are the considerations behind?

A1. Many countries have been faced with the pressing challenge of the rapidly spreading COVID-19 pandemic, and China is empathetic towards their difficult circumstances. Epidemic prevention and control efforts should not be separated by borders; the international community should join hands and stand in unison against the outbreak.

With President Xi Jinping personally overseeing and guiding the response, and with the arduous efforts of the whole nation, China is making constant progress in preventing and controlling its domestic outbreak. In the meantime, we are also deepening international cooperation on prevention and control, offering support and assistance to the rest of the international community to the best of our ability, It is our way of repaying other countries’ support at the outset of the outbreak, and an important step to back up global responses and build a community with a shared future for mankind.

Quality and safety of medical supplies bear on people’s life and health. The Chinese government attaches great importance to the quality and safety of medical supplies, as shown by our strict regulation governing relevant products. In such an epidemic, it becomes ever more crucial to step up quality monitoring and supervision and to better regulate export. Following the direction of the CPC Central Committee and the State Council, MOFCOM, the GAC and the NMPA jointly published an announcement on March 31, requiring that test reagents, medical facial masks, medical protective suits, ventilators and infrared thermometers for export must be certified by state medical products administration departments and conform with the quality requirements of the importing country or region. We will work with relevant departments to investigate all non-conforming exported products as they emerge. The cases will be handled in accordance with law, with no one left out, to ensure that the medical supplies are better utilized.

Meanwhile, foreign purchasers are encouraged to choose the suppliers that are registered at our medical products administration departments. Due quality inspections should be carried out prior to use, and the products should be used for their intended purposes and according to their operation specifications. We recommend that any issue that may arise when buying or using these supplies should be properly discussed and settled based on commercial principles. We are willing to work with the rest of the international community to foster a sound and orderly environment for the export of medical supplies that underpins global response.

Q2. If certain medical supplies are not granted a registration certificate from China’s medical products administration departments, but are certified under relevant foreign standards, are they allowed for export?

A2. It is required in the Announcement that medical supplies to be exported should be granted a registration certificate and, at the same time, conform with the quality standards and requirements of the importing country or region. For those medical supplies which are certified under relevant foreign standards but are not granted a registration certificate for medical devices and products in China, companies should file an application to medical products administration departments, as required. It should be noted that the registration information of Chinese medical devices and products included in the Announcement are collected as of March 31, 2020. The NMPA will provide updates constantly, which will be available on its official website (www.nmpa.gov.cn/WS04/CL2582/).

Q3. What measures have the GAC taken for the export clearance of medical supplies?

A3. COVID-19 has broken out in many countries around the world. The export of medical supplies is thus an important step to support epidemic response in certain countries and to deepen international cooperation on disease prevention and control. Under the coordinated leadership of the State Council inter-agency prevention and control task force, MOFCOM, the GAC and the NMPA jointly published an announcement on March 31, encouraging qualified Chinese companies to export medical supplies according to law, in an orderly manner and based on market principles, so as to play a positive role by stabilizing the export market of medical supplies. In this light, the GAC has formed a special working group to enhance coordination and leadership over the export of medical supplies. We have stepped up regulation and optimized services by inspecting and releasing medical supplies according to law and to the list of qualified businesses, and strengthened protection for intellectual property rights by cracking down on the export of infringing products such as medical devices and facial masks. Companies can file certifications in electronic forms. The inspection procedures have also been upgraded to be more precise and effective. Besides, the GAC have been leveraging multiple channels, including the 12360 “Customs Hotline”, to address the problems faced by companies in customs clearance and provide better services for qualified enterprises, contributing our part to global response against the outbreak.

Statistics show that since March 1, Chinese customs have inspected and released 2.77 billion masks, protective suits and other major medical supplies for export, with a total value of RMB¥6.29 billion.

Q4. After the Announcement is released, what are the changes to the business customs clearance procedures?

A4. Before the publication of the Announcement, when enterprises declare export for medical masks, medical protective suits, ventilators, COVID-19 test reagents and infrared thermometer, there is no need for them to provide the accompanying documents. The customs department does not have the port inspection requirements for regulatory documents. The invoices, packing lists and other documents would only need to be submitted if the review warrants so.

After the publication of the Announcement, when enterprises declare the export of the above five types of medical supplies, they need to provide the written or electronic declaration for the exported medical supplies and the registration certificates for medical devices and products listed in the Notice in the customs clearance process, compared with the previous provisions. The customs will inspect and release the goods based on the registration certificates for medical devices and products approved by the medical products administration department.

The customs will continue to strengthen regulation and optimize services, support qualified enterprises to expand exports, support the international community to jointly prevent and control the COVID-19, while also reminding enterprises to exercise strict quality control, adhere to integrity and comply with rules in operations, and prepare relevant documents in advance before exporting.

Q5. Regarding domestic approval for the five types of exported medical supplies for COVID-19 prevention

A5. Since the outbreak of COVID-19, the NMPA has attached great importance to this work and rapidly launched the emergency approval procedure for medical devices. The NMPA requires provincial medical product regulatory authorities to actively start the emergency approval of Class II medical devices within their jurisdictions, while strengthening product quality supervision. For the COVID-19 testing reagents, medical masks, medical protective clothing and other products, medical product regulatory authorities at all levels have innovated their review methods and conducted registration inspection, quality system verification and review of registration information in parallel, so as to speed up the review and approval with all their strength in accordance with the principle of “unified command, early intervention, timely review, science-based approval”, as well as the requirement to ensure product safety and effectiveness and exercise quality control.

As of March 31, 2020, the NMPA approved 25 COVID-19 detection reagents under the emergency procedure, including 17 nucleic acid detection reagents and 8 antibody detection reagents. Due to its methodological characteristics, antibody detection reagents are only used as a complementary test for suspected cases with negative results for the COVID-19 nucleic acid detection, or in conjunction with nucleic acid test in the diagnosis of suspected cases. It should not serve as a basis for the diagnosis and exclusion of COVID-19 infection, nor should it be used for screening the general population. Antibody detection reagents are for medical institutions only.

In addition, the NMPA and provincial medical product regulatory authorities also approved 67 product registration certificates for domestic ventilators, 302 product registration certificates for domestic medical protective suits, 153 product registration certificates for domestic medical protective masks, 549 product registration certificates for domestic medical surgical masks, 785 product registration certificates for domestic disposable medical masks, and 234 product registration certificates for domestic infrared thermometers (including ear thermometers and forehead thermometers). The relevant registration and approval information could be found on the NMPA’s website.

Q6. After the publication of the Notice, will the medical product regulatory authorities continue to issue Certificates of Free Sale for medical devices and products?

A6. The quality of exported medical devices is regulated by the importing country in accordance with international practice. Article 44 of China's Regulations for the Supervision and Administration of Medical Devices clearly states that: “Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region).”

In the process of exporting medical devices and products, some importing countries or regions sometimes require enterprises exporting medical devices to provide Certificates of Free Sale issued by the competent government departments of the country where the enterprises are located. In order to serve China’s medical device manufacturers in exporting products, the medical product regulatory authorities would issue a Certificate of Free Sale according to the needs of enterprises. Such certificate represents a service instead of a license and is not directly related to the customs clearance of goods.

In order to regulate the issuance of Certificates of Free Sale for medical devices, in June 2015, the state drug administration authorities issued the Regulations on the Administration of Certificate of Free Sale for Medical Devices and Products, which stipulates that when manufacturing enterprises have obtained registration certificates and manufacturing licenses for their medical devices and products or when the medical devices and products and the act of production have been registered in China, the medical product regulatory authorities may issue Certificates of Free Sale for medical devices and products for such enterprises. It is also provided that enterprises should ensure that the medical devices they export meet the requirements of the relevant regulations on the export of medical devices and the requirements of the importing country or region.

Manufacturers of exported medical devices could submit the following documents to the provincial medical product administration departments or their designated departments of the administrative region where they are located to apply for Certificates of Free Sale for medical devices and products: the registration forms for Certificates of Free Sale for medical devices and products, the original or copies of the business license of the company, licenses or registration certificates for the production of medical devices, and registration certificates or record of medical devices, and other information.

The Joint Notice made it clear that the customs will inspect and release the goods based on the registration certificates for medical devices and products approved by the medical product supervision and administration department. After the publication of the Notice, based on the Regulations on the Administration of Certificate of Free Sale for Medical Devices and Products, the medical product regulatory authorities may issue Certificates of Free Sale for medical devices and products for enterprises upon request and offer relevant services. Here we want to stress once again that the Joint Notice of the three departments provides that the customs will inspect and release the goods based on the registration certificates for medical devices and products approved by the medical product supervision and administration department, rather than on the basis of Certificates of Free Sale.