深圳医疗器械经营许可证办理指南

深圳医疗器械经营许可证办理指南医疗器械在使用过程中会对人体健康产生十分重要的影响，因此国家对于医疗器械有着严格地管理，目前我国医疗器械管理方面分成三类：一类——不用办理医疗器械许可证第一类医疗器械是风险程度低、Implementing routine management can ensure the safety and effectiveness of medical devices，Like a scalpel、surgical scissors、Manual hospital bed、medical ice pack、Cooling patches, etc.，Its products and production activities are subject to registration management by the local districted municipal food and drug regulatory authorities.。

All business activities will be liberalized，No permission or registration required，You only need to obtain a business license issued by the industrial and commercial department。

Category II - The Municipal Food and Drug Administration handles medical device business registration. Category II medical devices have moderate risks.，Medical devices that require strict control and management to ensure their safety and effectiveness，For example, the common band-aids in our daily life、condom、thermometer、sphygmomanometer、oxygen concentrator、Atomizer, etc.，Its products and production activities are licensed and managed by provincial food and drug regulatory authorities.，Issue "Medical Device Registration Certificate" and "Medical Device Production License" respectively。

Business activities are subject to registration management by the districted municipal food and drug regulatory authorities.;Category III - The State Food and Drug Administration applies for a medical device license. Category III medical devices carry higher risks.，Medical devices that require special measures to be strictly controlled and managed to ensure their safety and effectiveness，For example, a common infusion set、syringe、intravenous indwelling needle、heart stent、Ventilator、CT、NMR, etc.，Its products and production and operation activities are separately controlled by the State Administration of、Provincial food and drug regulatory authorities and districted city food and drug regulatory authorities implement licensing management，Issue "Medical Device Registration Certificate" separately、"Medical Device Production License"、"Medical Device Business License" The medical device business license is a must-have certificate for medical device operating companies.，Establishing a second-category 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；Establishing a third-category medical device operating enterprise，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"。

Medical device business license is now post-approval，The industrial and commercial administration department shall apply for approval after issuing a business license.。The "Medical Device Business Enterprise License" is valid for 5 years。Medical device business licenses can be divided into the following three categories:：医疗器械许可证对人员的

Require

1. 申请医疗器械经营许可证至少5个人，关外的公司最好6个人以上增加技术人员一名。
2. 经营范围含B类医疗器械的，企业负责人应具有医疗器械相关专业本科以上学历或医疗器械相关专业中级以上职称。
3. 经营范围含D类医疗器械的，应配备1名初级验光师以上职称的专业技术人员。
4. 企业负责人和质量负责人不得相互兼任。

Specific matters regarding administrative licensing conditions

1. 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";
2. 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"。

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