第三类医疗器械许可证资质办理

Detailed introduction of Hong Kong Xintong Peng Yi Aaron said that when applying for medical device qualifications, we need to prepare the corresponding materials in the early stage.，In the process of qualification application, we need to prepare a lot of information，and understand the entire application review process。

These parties can be simply divided into the following points based on the aspects of Hong Kong Xintong International's previous applications.：

1. 企业负责人应当熟悉医疗器械监督管理的规章制度和经营医疗器械的有关知识，对《医疗器械监督管理条例》第六十四条、第六十五条所述行为不得有记录。
2. 企业应当配备适合经营品种的专职质量管理人员（以下简称质量管理人员），每家店至少配备一人。
3. 企业质量管理人员根据书面授权行使质量管理职能，并根据授权对企业内医疗器械质量行使裁定权。
4. 质量管理人员应当具有相关承认的医疗器械或者相关专业中专以上学历或者相关专业初级以上技术职称。
5. 质量管理人员应当接受上岗培训，You can take up the job only after passing the exam。质管员应在岗，Not allowed to work part-time in other units。
6. 超过相关法定退休年龄不超过68周岁的质量管理人员，应当提供深圳市二级以上医疗机构出具的体检证明。
7. 经营下列产品的填写说明及

Require

：1、医疗器械经营许可证申请表可从深圳市食品药品监督管理局网站2下载专区下载。参照“示范文本”填写格式”。

文字材料和表格采用计算机打印，所有材料采用A4纸；

1. 提供的复印件应注明与原件及复印日期一致，And stamped with the official seal of the company；
2. 营业地址和仓库地址按“市名区名路名房号楼房号”；5顺序排列。

经营范围应当按照相关食品药品监督管理局颁发的医疗器械类别目录规定的经营类别，分类类别代码和类别代号填写，不得只填写“第三类医疗器械”；6可以零售的第三类医疗器械，通常有消费者自己使用的特殊说明。7、零售连锁企业申请医疗器械经营许可证的，申请材料参照医疗器械批发企业

Require

。

1. 企业为零售连锁企业或总公司分支机构的，医疗器械经营许可证申请材料由总公司或总公司1收集。提交的申请材料应加盖总公司或总公司印章；综合以上一些条件我们可以得知在办理医疗器械许可证的时候，A very large amount of information needs to be prepared。

When applying, you still need to go through multiple approval processes.，Therefore, when an enterprise needs documents related to medical device qualifications, it can consult Hong Kong Xintong International for processing.，Hong Kong Xintong International has thirteen years of business service experience in Shenzhen，There are many successful cases for medical device related qualification applications.。Familiar with the industrial and commercial process for medical device qualification application，Prepare clear preliminary information。Merchants in need please consult Hong Kong Xintong International as soon as possible。

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。