二类医疗器械经营许可证怎么办，Shenzhen Class II Medical Device Registration Online Application Process

医疗器械经营许可证是医疗器械经营公司的必备的保护性证件，Therefore, only by obtaining complete documents can we legally and compliantly conduct business cooperation with upstream and downstream enterprises in the same industry.。虽然很多企业老板都知道需要办理此资质，But how to do it、You will encounter many problems during the process。At this time, it will be delayed because it is not urgently needed or for other reasons.。Often you won’t be able to get it out when you need it urgently.。

所以经常会遇到查询资质的时候无证可拿的尴尬境地。The so-called preparedness，You can consult and apply for such certificates before you start to get involved in the industry.，Usually the period for document processing is longer than calling。When the market is really launched or when it encounters inspection by relevant departments, it will be difficult to make up for it with ideas.，所以还是在此刻咨询港信通团队进行相应资质的办理才是正确的选择。

A medical device business license is a must-have document for medical device operating companies.，开办类医疗器械经营企业，should report to the province、autonomous region、直辖市人民药品监督管理部门备案;Open a second category、Category III medical device operating enterprises，Should reflect on、autonomous region、直辖市人民药品监督管理部门审查批准，And issued a "Medical Device Business Enterprise License"。

Without a "Medical Device Business Enterprise License"，The industrial and commercial administration department shall not issue business licenses。

医疗器械许可证的经营场所、Warehouse area

Require

：

1. Business Category II、Class III medical device products，The usable area of ​​the business premises should be no less than 40 square meters，The usable area of ​​the business premises of a branch of a legal entity shall be no less than 25 square meters.(Except for those set up across districts and cities);Dealer of hearing aids，The usable area of ​​the business premises should not be less than 25 square meters;Those who deal in contact lenses and care solutions，The usable area of ​​the business premises should not be less than 10 square meters。
2. Business Category II、Class III medical devices(hearing aid、Contact lenses and care solutions、Disposable sterile medical device products in vitro diagnostic reagents、6846Implant materials and artificial organs、6877Except for interventional devices)，The usable area of ​​the warehouse should be no less than 30 square meters;Dealing in disposable sterile medical equipment，The warehouse should be in the same building，The usable area should be no less than 200 square meters。
3. Legal entity branch(Except for those established across districts and cities)and those specializing in medical devices and equipment，No need to set up a separate warehouse，However, it should be a legal entity or a manufacturer authorized to operate products.(Including import general agent)Unified procurement and distribution of original seals、Unified quality management、Commitments such as installation and after-sales service，And the registration certificate of the specialized products、Authorization documents and other proofs。
4. Dealing in hearing aids or contact lenses and their care solutions，No need to set up a warehouse，But there should be a special counter for storage。
5. In principle, the declared business premises and warehouse shall be located nearby within the same administrative area.，and shall not be located in residential buildings、force、public security、Inside the armed police camp。

二类医疗器械经营许可证编辑二类医疗器械经营许可证企业人员资质的

Require

：1.Operating third-class medical device products，quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management(medical device、biomedical engineering、mechanical、Electronics, etc.)College degree or above or intermediate technical title or above in related majors。

Dealing in disposable sterile medical equipment,There should also be at least one internal auditor holding a medical device quality management system internal auditor certificate.(The quality manager shall not concurrently serve as)。

1. Those operating Class II medical device products，quality manager、The person in charge of the quality organization should have a nationally recognized、Majors related to product management(medical device、biomedical engineering、mechanical、Electronics, etc.)Technical secondary school degree or above or junior technical title or above in related majors。
2. Business Category II、Class III medical device products，Technical training and after-sales service personnel(medical device、biomedical engineering、mechanical、electronic)etc. should have a technical secondary school degree or above or a junior technical title or above in a major related to the products they operate.。
3. Those who deal in hearing aids or contact lenses and care solutions，The quality manager shall be a third-party organization recognized by the state or a production enterprise authorized to operate.(Including import general agent)Contact lens fitting technology training。
4. Quality managers and heads of quality organizations are not allowed to hold concurrent jobs。看完清晰以上关键点之后，相信您对于怎么办理行业内的资质认证已经有了一个初步的了解了，那么接下来就抓紧进行咨询港信通团队进行资质办理吧。只要证件齐全相信一定会在商海之中有一定的斩获的，不会在因为证件的问题遇到相关部门的核查，只要遵守市场规则，才会被规则所保护。

Related products：二类医疗器械经营许可证办理

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