Port communication医疗器械经营许可证办理所需资料，深圳医疗器械经营许可证办理指南第一类医疗器械是风险程度低、Implementing routine management can ensure the safety and effectiveness of medical devices，Like a scalpel、surgical scissors、Manual hospital bed、medical ice pack、Cooling patches, etc.，Its products and production activities are subject to registration management by the local districted municipal food and drug regulatory authorities.。
All business activities will be liberalized，No permission or registration required，You only need to obtain a business license issued by the industrial and commercial department。
Class II medical devices are those with moderate risk，Medical devices that require strict control and management to ensure their safety and effectiveness，For example, the common band-aids in our daily life、condom、thermometer、sphygmomanometer、oxygen concentrator、Atomizer, etc.，Its products and production activities are licensed and managed by provincial food and drug regulatory authorities.，Issue "Medical Device Registration Certificate" and "Medical Device Production License" respectively。
Business activities are subject to registration management by the districted municipal food and drug regulatory authorities.;Class III medical devices are those with higher risks，Medical devices that require special measures to be strictly controlled and managed to ensure their safety and effectiveness，For example, a common infusion set、syringe、intravenous indwelling needle、heart stent、Ventilator、CT、NMR, etc.，Its products and production and operation activities are separately controlled by the State Administration of、Provincial food and drug regulatory authorities and districted city food and drug regulatory authorities implement licensing management，Issue "Medical Device Registration Certificate" separately、"Medical Device Production License"、"Medical Device Business License"。
个人去办不熟悉流程的话往往跑了很多趟还办不下来，If you need someone to do it，It’s best to find a professional agency，具体可以根据新修订的《医疗器械监督管理条例》的规定，开办第Ⅱ类医疗器械经营企业、第Ⅲ类医疗器械经营企业需要办理医疗器械经营许可证或医疗器械网络经营备案。
申请办理医疗器械经营许可或备案的企业，应具有符合规定的经营场所、质量技术人员及经营质量管理体系。
解决疑难问题▲场地问题（商业或者办公使用性质）三类
Require
160Above average，其中100办公，60平库房▲库房布置（干净整洁、通风避光）仓库
Require
三色五区布置，要有货架，出库软件等▲人员问题（二类医疗器械备案）质量负责人大专以上医疗器械相关专业，三年以上工作经验，其他验收、technology、库房人员等▲特殊
Require
（医疗器械网络经营备案）6840体外诊断试剂（冻库20立方，发电机等），验光师及验光设备▲软件问题（医疗器械经营许可证办理）医疗器械进销存软件，出库单，以及软件应用问题推荐机构国际提供医疗器械经营许可证办理，Labor dispatch business license application，Human Resources Service License，旅行社经营许可证申请、深圳地区旅行社经营资质申请。
Hazardous chemicals business license
Application conditions
、Hazardous chemicals business license
Application process
、Food business license application、and other types of business qualification applications、Application for radio and television program operation and production license、Application for Internet Culture Audiovisual License、网络文化经营许可证申请等综合服务等各类资质许可证办理，Details available。/：address：Ping An International Financial Center 70F
About Hong Kong Xintong
Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。
