Port communication二类医疗器械备案有哪些
Require
二类医疗器械备案有哪些
Require
？怎么在深圳进行二类医疗器械备案？ 对于二类医疗器械备案很多人都很陌生，甚至有时候都不清楚自己所经营的产品是在二类医疗器械的范畴里。那么怎么才能知道自己所经营的产品是不是在二类医疗器械的范畴里呢？
主要的区分办法就是对照医疗器械产品目录了，这个找的时间可能会久一点。今天就一起来了解下怎么办理二类医疗器械备案。 二类医疗器械备案
Require
： (one)Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。
Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state； (two)Have a relatively independent business location that is commensurate with the business scale and scope of business； (three)Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices
Require
storage facilities、equipment； (Four)A sound product quality management system should be established，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking system and adverse event reporting system, etc.； (five)Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support。
这些都是申请的公司需要满足的基本
Require
，而二类医疗器械备案也分为批发和零售两种，也可以两类都经营。这个是经营方式的一种区分，而在申请二类医疗器械备案的时候对于资料也有详细的列表。
二类医疗器械备案资料：
- Copy of the company's "Business License"(Verify original)；
- Legal representative of the enterprise、person in charge、质量管理负责人的身份证、Copies of academic qualifications or professional title certificates and resume；
- ID card of the quality management personnel of the proposed enterprise、Copy of academic qualification or professional title certificate；
- The organizational structure and functions of the proposed enterprise or the functions of full-time quality management personnel；
- 拟办企业经营场地、Geographical location map of warehouse address、floor plan(注明使用面积)、房屋产权证明或者租赁协议(附租赁房屋产权证明，The same below)a copy；
- 拟办企业产品经营质量管理制度文件、Work procedures (in vitro diagnostic reagent wholesale companies only) and storage facilities、Device catalog；
- Certificate of authorization of the person in charge；
- Other supporting materials。
在对于申请资料的审查的时候，对于人员的审查最为严格，首先需要所学的专业对称，之后就是学历的
Require
，必须是大专或大专以上学历的人员。这两名人员的花是作为主要的负责人员。 以上这些就是申请二类医疗器械备案的时候需要满的基本
Require
以及需要的资料，Hope it helps everyone。
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