三类医疗器械许可证办理相关资料

详细介绍医疗器械经营许可证是经营三类医疗器械的企业必须具备的一个许可证明。Because Class III medical devices have a great impact on human health，The state also has very strict control over it，There are also many related directories。If you are not sure about the classification of the medical devices you operate，也可以联系在线客服获取详细的目录参考，This article will not go into details，It mainly introduces relevant information about application for Class III medical devices.。

申请注册二类、三类医疗器械流程中的重点节点：

1. Prepare information for application：Through the Guangdong Provincial Government Service Network，Search the name of the approval item "Medical Device Registration Approval"，Select "Issuance of Class II Medical Device Registration Certificate"。Fill in the application information online，and upload relevant electronic documents。
2. Acceptance of materials submitted on site：办理机关收到网上申请材料之日起5个工作日内确定是否受理，对行政相对人进行信用信息查询并实施联合奖惩。Application materials are incomplete or do not comply with legal forms，Notify the applicant of all the necessary supplements and corrections within five days，Failure to notify after the due date，The application will be accepted from the date of receipt of the application materials.。
3. Waiting to get the processing result：申请人可登陆广东省食品药品监督管理局公众网首页审批查询栏进行办理进度查询，或登陆网上办事平台查询进度。Electronic certificates have been implemented for this matter，No additional paper certificates will be issued，Applicants can apply for certification themselves，You can also go to the provincial bureau acceptance hall with your digital certificate to print the certificate yourself.。

申请注册二类、Information that should be prepared before using Class III medical devices：

1. Prepare the registered company
2. 办公地址的

Require

：（租赁平正原件-办公、The actual usable area is more than 80㎡，Recommend about 120㎡)、floor plan，storehouse：The actual usable area is more than 40 square meters

1. legal representative、supervisor、股东身份正复印件及U盾
2. legal representative、Business person in charge、Quality manager (resume) with correct identity、学历或者职称正明、体检正明原件
3. Professional and technical personnel (quality managers、Acceptance personnel、computer maintenance、Warehouse personnel、repair、售后）身份正、学历正明（医疗器械相关专业）
4. 医疗器械专用系统软件港信通协助代理

Application process

time flow：签订服务合同→准备申请资料→提交政府主管单位审核→通过初审→预约专管官员现场审查→审查通过进行复审→复审通过取正书面向医疗行业的企业主中我们的服务

1. 医疗器械经营许可证（包括体外诊断试剂）换证我们为境内体外诊断试剂经营、流通和贸易企业提供全方位、一站式的医疗器械经营许可证换证办理服务。
2. 医疗器械（包括体外诊断试剂）新办理及变更从事第三类经营的企业，协助经营企业向所在地的市级食品药品监督管理部门提出申请办理。
3. 二类医疗器械备案及注销从事第二类经营的企业，协助经营企业向所在地的市级食品药品监督管理部门提出申请备案。
4. Medical device online transaction service third-party platform’s first registration service
5. According to the innovation needs of enterprises across the entire industry chain，提供个性化咨询及服务医疗器械经营许可正使用期限
6. 《医疗器械经营企业许可正》的有效期为5年。

Validity expires，需要继续经营医疗器械产品的，Medical device operating enterprises shall notify the company 6 months before the expiration date，药品监督管理部门机构申请换发《医疗器械经营企业许可正》。

1. （食品）药品监督管理部门机构按照本办法规定对换正申请进行审查。
2. （食品）药品监督管理部门认为符合

Require

of，应当在《医疗器械经营企业许可正》届满时予以换发新正，收回原《医疗器械经营企业许可正》；4.Not eligible，应当限期进行整改，整改后仍不符合条件的，应当在有效期届满时注销原《医疗器械经营企业许可正》，书面告知申请人并说明理由，At the same time, the applicant is informed that he or she has the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.。

医疗器械监督管理办法《医疗器械经营监督管理办法》已于2014年6月27日经国家食品药品监督管理总局局务会议审议通过，Now announced，自2014年10月1日施行。

港信通国际九年专注于深广东省内医疗器械许可正代理申请，包含二类医疗器械、三类医疗器械许可证申请、Add items、变更以及注销业务，Rich window service experience、熟悉各项工商

Process

，从咨询、Additional conditions、备齐材料到审核、发放资质，港信通国际始终秉承一站式服务理念，港信通国际成熟的办理模式，也是服务行业内具有价格

Advantages

的原因。

有需要了解二类医疗器械网络销售备案，以及三类许可证办理的，也可以点击下方链接，详细参考一下。二类医疗器械网络销售备案三类医疗器械经营许可证办理

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。