在深圳办理二类医疗器械经营备案你需要满足的条件

在深圳办理二类医疗器械经营备案你需要满足的条件 在深圳办理二类医疗器械经营备案你需要满足的条件 一类医疗器械可以直接经营，只要有公司营业执照即可，第二类医疗器械需要办理第二类医疗器械经营备案方能合法经营，而第三类医疗器械就厉害了，需要办理三类医疗器械经营许可证方能合法经营。

本篇文章介绍一下办理深圳二类医疗器械经营备案的

Require

和所需材料。

two、Shenzhen Class II Medical Device Registration

Require

1. enterprise、Legal representative of the enterprise or person in charge of the enterprise、The person in charge of quality management has no Article 63 of the "Regulations on the Supervision and Administration of Medical Devices"、Situations provided for in Article 65；
2. Have business premises and storage conditions commensurate with the business scale and scope of business；
3. Have quality management systems and quality management organizations or personnel that are suitable for the medical devices they operate.。

three、Materials required for Shenzhen medical device registration

1. Class II medical device business registration form；
2. Copy of enterprise business license；
3. Legal representative or person in charge of the enterprise、Identity of quality manager、Educational qualifications、职称证明复印件及相关人员（批发公司：Business person in charge、warehouse keeper、Salesperson and quality manager；store：Quality Manager) training certificate；
4. Description of corporate organization and department settings；
5. Business premises、Geographical location map of warehouse address、Floor plan (indicate actual usable area)、Copy of property ownership certificate or lease agreement (with property ownership certificate attached)；
6. Catalog of business facilities and equipment；
7. Enterprise operation quality management system、Work program and other file directories；
8. Shaoguan Medical Device Business Enterprise (Wholesale、Retail) self-check sheet；
9. Quality and Safety Commitment Letter for Medical Device Business Enterprises；
10. Commitment Letter on Safety Production of Medical Device Operating Enterprises；
11. Authorization letter from the person in charge；
12. Self-guarantee statement on the authenticity of filing materials；
13. Electronic version of filing materials。

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