How to handle medical consumables export agency? These 8 key questions must be understood!
As a 20-year foreign trade veteran, Im often asked an interesting question: Why do seemingly similar paper products have completely different customs classifications? Today, lets uncover the identity code of household paper products like detectives solving a case.
Certification maze: No pass means no entry
How can medical plastic products expand into overseas markets through agency companies? These key issues must be understood!
June 27, 2025
醫(yī)療塑料出口需要哪些特殊資質(zhì)認(rèn)證？ 根據(jù)2025年最新國際貿(mào)易規(guī)范，醫(yī)療塑料制品出口需重點(diǎn)關(guān)注三類認(rèn)證： 基礎(chǔ)生產(chǎn)資質(zhì)：ISO13485醫(yī)療器械質(zhì)量管理體系認(rèn)證 目標(biāo)市場準(zhǔn)入認(rèn)證： 美國FDA 510(k)或PMA認(rèn)證 歐盟CE-MDR認(rèn)證（2020年升級(jí)版仍有...
How to become a medical equipment export agent? A comprehensive analysis of the latest compliance points for 2025.
July 13, 2025
一、醫(yī)藥器材出口需要哪些資質(zhì)認(rèn)證？ 根據(jù)2025年最新國際貿(mào)易規(guī)范，醫(yī)藥器材出口需滿足雙重認(rèn)證體系： 國內(nèi)強(qiáng)制資質(zhì)： 醫(yī)療器械注冊證/備案憑證（NMPA） 醫(yī)療器械生產(chǎn)許可證 進(jìn)出口經(jīng)營權(quán) 目標(biāo)市場準(zhǔn)入認(rèn)證： 歐盟CE認(rèn)證（注意2025...
How to become a total export agent for pharmaceuticals? These six key issues must be clarified.
August 1, 2025
如何選擇醫(yī)藥出口總代理機(jī)構(gòu)？ 選擇醫(yī)藥出口總代理需重點(diǎn)考察三個(gè)維度：專業(yè)資質(zhì)、行業(yè)經(jīng)驗(yàn)和全球網(wǎng)絡(luò)。優(yōu)質(zhì)代理機(jī)構(gòu)應(yīng)具備： 藥品經(jīng)營許可證和GSP認(rèn)證 至少5年醫(yī)藥產(chǎn)品出口實(shí)操案例 在目標(biāo)市場擁有自營清關(guān)團(tuán)隊(duì) 熟悉WHO預(yù)認(rèn)證及PIC/S規(guī)范 ...
33. How to act as an agent for wheelchair exports? 2025s latest practical answers
March 30, 2025
34. What qualifications are required for medical device exports? As a category of medical devices, wheelchair exports require special attention to: Domestic qualifications: Class II medical device business filing certificate (domestic products), Import and export rights and customs filing, In 2025, a new cross - border medical device traceability system filing. Target country certifications: EU CE certification (MDD 93/42/EEC or new MDR...
How to choose a professional wheelchair export agent? Complete guide to foreign - trade services in 2025
April 29, 2025
I. What Kind of Agency Company is a Qualified Wheelchair Export Service Provider? When choosing an agency company, three dimensions should be mainly considered: qualification compliance, industry experience, and resource integration ability. First, verify its AEO certification status of the customs. Since 2025, the EU has required that agents of medical device products must hold the ISO 13485 Quality Management System Certification. Necessary Qualification List...
LED light source lifespan test data
May 14, 2025
I. What qualifications are required for exporting wheelchairs as an agent? According to the latest international trade regulations in 2025, the agency enterprise must possess: Medical device operation filing certificate (applicable to medical wheelchairs), ISO 13485 quality system certification, Export goods consignor/consignee filing, Special market access qualifications: EU CE certification (EN 12184 standard), US FDA registration (21 C...
How to Start a Wheelchair Export Agency Business? These 7 Key Questions You Must Know
August 29, 2025
輪椅出口需要哪些產(chǎn)品認(rèn)證？ 根據(jù)2025年國際貿(mào)易新規(guī)，輪椅出口需重點(diǎn)關(guān)注以下認(rèn)證： 歐盟市場：CE認(rèn)證（包含EN 12184醫(yī)療電氣設(shè)備標(biāo)準(zhǔn)） 美國市場：FDA注冊（I類醫(yī)療設(shè)備備案） 日本市場：PMDA認(rèn)證（需提供JIS T9203測試報(bào)告） 通用認(rèn)證：ISO ...
Is it mandatory to find an agent for exporting medical devices? How to choose a reliable service provider?
July 19, 2025
一、如何判斷醫(yī)療器械出口是否需要專業(yè)代理？ 根據(jù)2025年最新海關(guān)總署數(shù)據(jù)，以下三類情況必須委托專業(yè)代理： 首次出口二/三類醫(yī)療器械的企業(yè)（海關(guān)特殊監(jiān)管代碼要求） 涉及植入式/生命維持類高風(fēng)險(xiǎn)產(chǎn)品（需特別資質(zhì)備案） 目標(biāo)市場為歐盟/美國/...
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