办理深圳二、三类医疗器械经营许可证流程

按照各领域和主体类型所对应的《自查问题清单》，逐款逐项对生产经营行为进行全面检查，及时发现和纠正违法违规行为，并形成自查报告。《自查问题清单》由企业法定代表人或负责人签字确认后，连同自查报告一并留存备查。

A medical device business license is a must-have document for medical device operating companies.，Start a first-class medical device operating enterprise，should report to the province、autonomous region、Registration with the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government;Open a second category、Category III medical device operating enterprises，Should reflect on、autonomous region、Review and approval by the drug regulatory department of the municipal people’s government，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。The "Medical Device Business Enterprise License" is valid for 5 years。

Administrative licensing content：

1. Review and issue the newly issued "Medical Device Business Enterprise License"(second、Class III medical devices)
2. Category 2、Class III medical device business enterprise merger、Legal basis for establishment of permission for division or transfer across original jurisdictions(1)、"Regulations on the Supervision and Administration of Medical Devices";(2)、"Measures for the Administration of Licenses for Medical Device Business Enterprises" Specific Matters on Administrative Licensing Conditions：
3. Legal representative of the enterprise、Business person in charge、Quality management personnel should not have the circumstances specified in Article 40 of the "Regulations on the Supervision and Administration of Medical Devices";
4. The enterprise should have a quality management organization or full-time quality management personnel that is commensurate with its business scale and scope.;Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state，Professional and technical personnel who have been qualified in accordance with the law。

For example, the quality manager should be on-the-job，Not allowed to work part-time in other units

1. Have a relatively independent business location that is commensurate with the business scale and scope of business。
2. Have storage conditions suitable for the business scale and business scope(storage device、facility)。
3. Have technical training on operating products、After-sales service capabilities。
4. Should be based on relevant national and local regulations，Establish and improve the necessary quality management system，and strictly enforce。
5. National standards for medical devices should be collected and preserved、Industry standards and regulations on medical device supervision and management、Regulations and special provisions。
6. Passed the acceptance inspection in accordance with the "Implementation Standards for the Acceptance of Medical Device Business Enterprises in Guangdong Province"。目前深圳二、Class III medical devices，Food business，地址一纸难求，政策法规条例众多，申报手续繁琐复杂。

许多客户往返奔波，耗费大量人力物力，许可证却还是迟迟办不下来，严重影响企业的正常经营和发展。深圳是一家专业提供公司企业注册，Register，代理记账服务的公司，尤其擅长为客户一站式办理各类经营许可证。

我司在免费为代理记账企业公司登记注册的同时，针对目前市场上需求量大，地址紧缺的二、Class III medical device business license，积极运作，并且全程指导客户准备申报资料。在监管部门开设出绿色通道，为企业办理许可证争取到最大的便利，最迅捷的时间。

深圳商务有限公司港信通-：;address：┯ ┰ ┱ ┲ ┳ ┴ ┵ ┶ ┷ ┸ ┹ ┺ ┻┼ ┽ ┾ ┿对真正的成功者来说，不论他的生存条件如何，都不会自我磨灭自身潜藏的智能，不会自贬可能达到的人生高度。

他会锲而不舍地去克服一切困难，发掘自身才能的最佳生长点，扬长避短地踏踏实实地朝着人生的最高目标坚定地前进!

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