Recently, the Provincial Commerce Department, the Provincial Medical Products Administration and Changchun Customs jointly released a notice on strengthening the quality management of medical supply exports (hereinafter referred to as "the notice"), so as to further promote the production of medical supplies, push import and export enterprises to participate in the international cooperation of epidemic prevention and control in a positive and orderly manner, strengthen the quality management and standardize the export order.
According to the notice, the enterprises operating Class II and Class III medical devices shall obtain an operating permit or a record certificate for medical devices in accordance with the regulations, and the medical devices shall obtain a registration certificate or a record certificate. No export sales certificate shall be issued to any manufacturing enterprise with no production license or record certificate for medical devices, nor issued to any medical device with no registration certificate or record certificate. For the exported medical devices, organize the production and guarantee the effective operation of the quality management system in strict accordance with the regulations on the supervision and management of medical devices as well as the standards on the production quality management of medical devices. The products must conform with the approved technical requirements, provide the factory inspection report and meet the standard quality requirements of the importing country (region). At the time of going through customs clearance, it is necessary to provide registration certificates or record certificates for medical devices approved by medical product administrations and statements of exported medical supplies. For the exported non-medical supplies, enterprises need to achieve the business qualification, and the exported products need to pass the inspection and meet the quality standards of the importing country (region). Those non-medical supplies cannot be declared as medical products at the time of going through customs clearance.
According to the notice, the enterprises shall strictly observe the quality and safety management regulations to ensure the quality and safety of products. The cross-border e-commerce retail exports and donated supplies shall strictly observe the relevant management regulations to ensure that the exported medical supplies meet the requirements of safety, hygiene and health.
