Recently affected by the global outbreak, the demand for face masks and other anti-epidemic materials has increased greatly, the export of face masks has become the focus of attention. So, mask export, what qualifications do you need? What information is required? First, to understand the relevant qualification of Medical Devices: l engaged in the production of first class medical devices, by the manufacturer to the location of the district-level Government of the People's Republic of China for the record; For those engaged in the production of second-class and third-class medical devices, the manufacturing enterprise shall apply for the production license to the Government of the People's Republic of China of the local province and municipality directly under the Central Government; The operation of Class I medical devices does not require permission and record-keeping; the operation of Class II medical devices shall be subject to record-keeping management, and the operation of medical devices shall be subject to record-keeping certificate; the operation of Class III medical devices shall be subject to license management, apply for medical device business license. For details, please refer to the Regulations on the supervision and administration of Medical Devices, the measures on the supervision and administration of the production of medical devices and the measures on the supervision and administration of the operation of medical devices. Medical Masks are classified as second class medical devices and should be within the scope of business, obtain Medical Device Registration certificate/medical device production license/medical device business record qualification, have import and export business right. A non-medical masks (not included in the scope of medical devices) should be marked "non-medical" when declared for export: 1. Invoice, packing list 2. CMA CNAS and certificate of conformity (inspection list)3. B when declaring the export of Medical Masks, the remarks column shall be entered "epidemic prevention materials and certificate number" 1. Invoice, packing list 2. Certificate for record of medical device business. 3. Inspection Report (CMA, CNAS) and certificate of conformity (inspection list)4. Other documents required by the customs for additional instructions, important reminder (medical masks, etc.)1. For the export of Medical Devices, the production enterprise shall first handle the export record and the export sales certificate (see the end of the web site) , and shall establish and keep the export product files. The contents include the medical device export sales certificate and the medical device export record form, the purchase contract, quality requirements, inspection report, qualification certificate, packaging, label style, customs declaration, etc. , to ensure the traceability of the export process. 2. Those who produce and Export Medical Devices shall ensure that the medical devices they produce meet the requirements of the importing country (region) , and shall put the product information for the record to the municipal food and drug supervision and administration department with a district in their locality. 3. Where a manufacturing enterprise accepts an overseas enterprise's entrustment to manufacture medical devices for sale abroad, it shall obtain the third party certification of the medical device quality management system or the domestic production license or record of similar products. 4. No matter what kind of trade mode, unqualified products can not be exported normally. 5. The declaration shall be marked as epidemic prevention materials, and upon export the goods shall be cleared according to the inspection instructions, and the quality inspection report (or spot sampling for inspection) shall be provided in accordance with the requirements for on-site inspection by the customs, and can provide three certificates complete (medical device registration certificate, medical device production license, medical device business license) . The management of Class II medical devices shall be subject to the record-keeping management, and shall handle the certificates for the record-keeping of medical devices. For details, please refer to the Regulations on the supervision and administration of Medical Devices, the measures on the supervision and administration of the production of medical devices and the measures on the supervision and administration of the operation of medical devices
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