海關監(jiān)管

為進一步加強新冠肺炎疫情期間出口防疫物資質量安全監(jiān)管，避免出口不合格防疫物資，海關近期在貨物貿易渠道，開展了出口口罩、防護服、護目鏡、手套、呼吸機等防疫物資質量安全監(jiān)管專項工作。

對存在質量安全問題的出口防疫物資依法依規(guī)實施快速處置，對發(fā)現(xiàn)企業(yè)有出口防疫物資偽瞞報、夾藏夾帶、摻雜摻假、以假充真、以次充好或者以不合格冒充合格等違法行為的，將嚴格依法依規(guī)進行處理。

歐盟醫(yī)療器械法規(guī)MDR（EU 2017/745）于2017年5月25日正式生效，與舊的醫(yī)療器械指令MDD（93/42/EEC）交替使用過渡期為三年。因此，按照舊的醫(yī)療器械指令MDD（93/42/EEC）所獲CE認證的口罩等醫(yī)療器械產(chǎn)品，需面臨換版問題。對已經(jīng)在歐盟渠道正式上市的產(chǎn)品，MDD（93/42/EEC）指令CE證書可以保持到2024年5月26日，今年5月26日前未能上市的產(chǎn)品，原則上應將舊的MDD證書重新申請調整到MDR版本。MDR的審核流程和要求更為復雜繁瑣，認證周期更長，企業(yè)應引起注意。

For novel coronavirus pneumonia epidemic prevention and quarantine materials to improve the quality and safety supervision during the epidemic situation, and to avoid the export of unqualified anti epidemic materials, the Customs recently carried out export safety management of special materials for export of respirators, protective clothing, goggles, gloves and ventilator.

The export epidemic prevention materials with quality and safety problems shall be disposed quickly in accordance with the laws and regulations, and the enterprises found to have such illegal behaviors as false report, entrapment and entrainment, adulteration, counterfeiting, shoddy or disqualified as qualified shall be dealt with in strict accordance with the laws and regulations.

The EU medical device regulation MDR (EU 2017 / 745) came into force on May 25, 2017, and the transition period between MDR and the old medical device directive MDD (93 / 42 / EEC) is three years. Therefore, according to the old medical device directive MDD (93 / 42 / EEC), medical device products such as masks with CE certification need to face the problem of version change. For the products that have been officially listed in the EU channel, the CE certificate of MDD (93 / 42 / EEC) directive can be maintained until May 26, 2024. For the products that have not been listed before May 26, 2024, in principle, the old MDD certificate should be reapplied and adjusted to the MDR version. The audit process and requirements of MDR are more complex and tedious, and the certification cycle is longer, so enterprises should pay attention to it.

李國杰（經(jīng)理）：18202125732  

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