2025深圳第二类医疗器械经营备案代办要求

按照医疗器械风险程度，医疗器械经营实施分类管理。经营类医疗器械不需许可和备案，The operation of Class II medical devices shall be subject to registration management，License management is implemented for operating Class III medical devices。

深圳医疗器械经营备案，医疗器械经营许可证办理咨询从事第三类医疗器械经营的，经营企业应当向所在地设区的市级人民政府食品药品监督管理部门申请经营许可并提交其符合规定条件的证明资料。受理经营许可申请的食品药品监督管理部门应当自受理之日起30个工作日内进行审查，必要时组织核查。

对符合规定条件的，准予许可并发给医疗器械经营许可证；医疗器械经营许可证有效期为5年。The validity period has expired and needs to be extended，Handle extension procedures in accordance with legal provisions on administrative licensing。

Engaged in medical device business，The following conditions should be met：

1. Have quality management organizations or quality management personnel that are commensurate with the business scope and scale of operations，Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；
2. Have operations that are commensurate with the business scope and scale of the business、storage place；
3. Have storage conditions suitable for the business scope and scale，If all storage is entrusted to other medical device operating enterprises, there is no need to set up a warehouse.；
4. Have a quality management system suitable for the medical devices it operates；
5. Have professional guidance appropriate to the medical devices being operated、Technical training and after-sales service capabilities，Or agree to provide technical support from relevant institutions。

Enterprises engaged in the operation of Class III medical devices shall also have medical device operation quality management

Require

computer information management system，Ensure the traceability of products sold。鼓励从事类、第二类医疗器械经营的企业建立符合医疗器械经营质量管理

Require

computer information management system。

从事第三类医疗器械经营的，The operating enterprise shall submit an application to the local food and drug supervision and administration department at the districted municipal level.，and submit the following information：

1. Copies of business license and organization code certificate；
2. legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate；
3. Organizational Structure and Department Setup Instructions；
4. Business scope、Description of business methods；
5. Business premises、Geographical location map of warehouse address、floor plan、Copy of property ownership certificate or lease agreement (with property ownership certificate attached)；
6. Business facilities、Device catalog；
7. Operation quality management system、Work program and other file directories；
8. Basic introduction and function description of computer information management system；
9. Certificate of authorization of the person in charge；
10. Other supporting materials。

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Require

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