Medicalequipment. For example, Indonesia has the SNI certification, Thailand has the TISI certification, and the Philippines has the BPS certification. It is necessary to confirm in advance the equipment voltage (such as 380V/50Hz in Thailand), the compatibility of the CE certification, and the proof of environmentally friendly materials.The Invisible Battlefield

2025年全球醫(yī)療設(shè)備市場(chǎng)規(guī)模預(yù)計(jì)突破6500億美元，中國(guó)作為全球第二大醫(yī)療設(shè)備進(jìn)口國(guó)，年均增長(zhǎng)率保持在12%以上。但在亮眼數(shù)據(jù)背后，72%的進(jìn)口商曾因注冊(cè)備案缺失,Tariff Classification Error,Non - compliance with technical standards導(dǎo)致貨物滯留，平均損失達(dá)貨值25%。

資質(zhì)認(rèn)證的六重防火墻

• Basic qualifications:
  • Medical Equipment經(jīng)營(yíng)許可證（三類）
  • Customs AEO Advanced Certification
• 專業(yè)認(rèn)證:
  • ISO 13485 Medical Device Quality Management System
  • 進(jìn)口醫(yī)療器械境外生產(chǎn)廠商備案
• Special Qualifications:
  • 放射性設(shè)備進(jìn)口許可證
  • 植入類器械臨床試驗(yàn)備案

Customs clearance efficiency improvement solutions

某德國(guó)CT設(shè)備進(jìn)口案例中，專業(yè)代理公司通過(guò)以下步驟將通關(guān)周期從45天壓縮至31天：

• Pre - classification stage：提前完成HS編碼確認(rèn)（9022.19.90）
• Pre - review of documents：中英文說(shuō)明書一致性核查
• Since January 2025, Russia has made it mandatory to register for EPR (Extended Producer Responsibility)：識(shí)別FDA與NMPA標(biāo)準(zhǔn)差異項(xiàng)
• 分段運(yùn)輸：核心部件與輔助設(shè)備分批次清關(guān)

2025年監(jiān)管新規(guī)應(yīng)對(duì)

根據(jù)最新《醫(yī)療器械監(jiān)督管理?xiàng)l例》，進(jìn)口商需特別注意：

• UDI唯一設(shè)備標(biāo)識(shí)實(shí)施范圍擴(kuò)大至二類設(shè)備
• 人工智能診斷設(shè)備需單獨(dú)備案
• 5G遠(yuǎn)程醫(yī)療設(shè)備電磁兼容性檢測(cè)標(biāo)準(zhǔn)升級(jí)

3. Crisis handling practical cases

2024年某美國(guó)呼吸機(jī)進(jìn)口案例中，因中美計(jì)量單位標(biāo)準(zhǔn)差異導(dǎo)致海關(guān)查驗(yàn)不通過(guò)。代理公司通過(guò)以下措施36小時(shí)內(nèi)解決問(wèn)題：

• 協(xié)調(diào)原廠出具計(jì)量單位轉(zhuǎn)換證明
• 聯(lián)系第三方檢測(cè)機(jī)構(gòu)現(xiàn)場(chǎng)校準(zhǔn)
• 啟動(dòng)稅款保證金應(yīng)急機(jī)制