深圳医疗器械二类零售备案办理条件和提交材料解析

712th of the month，国家药品监督管理局发布《医疗器械生产质量管理规范附录独立软件》（以下简称《附录》），旨在加强独立软件类医疗器械生产监管，规范独立软件生产质量管理。该附录拟于2025年7月1日起实施。

A medical device business license is a must-have document 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。那么医疗器械二类零售备案如何办理了？今天为大家整理了相关资料供大家参考。

1. Category II medical device retail registration is subject to Category II medical device business registration

Application conditions

of enterprises;Enterprises holding the "Class II Medical Device Business Registration Certificate"，In other words, it must be in the capacity of a company (enterprise) license。

1. The conditions for acceptance are quality management institutions or quality management personnel that are suitable for the business scope and scale of business.，Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；Have operations that are commensurate with the business scope and scale of the business、storage place；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.；Have a quality management system suitable for the medical devices it operates；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。
2. Material information required to apply for Class II retail registration of medical devices：
3. Class II medical device business registration application form
4. Copy of "Business License"
5. Copy of "Organization Code Certificate"
6. legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate
7. Organizational Structure and Department Setup Instructions
8. Business scope、Description of business methods
9. Business premises、Geographical location map of warehouse address、floor plan、Copy of property ownership certificate or lease agreement
10. Business facilities、Device catalog
11. Operation quality management system、Work program and other file directories
12. How to distinguish whether it is a "Class II medical device"
13. The product packaging is marked with "Food and Drug Supervision Equipment"(allow)"XXXX No. 1XXXXXX" is a Class I medical device，No filing required；
14. The product packaging is marked with "Food and Drug Supervision Equipment"(allow)"XXXX No. 2XXXXXX" is a Class II medical device，Filing required；Notice：According to the provisions of the "Measures for the Supervision and Administration of Medical Device Operations"："Enterprises engaged in the operation of Class II medical devices shall register with the local food and drug supervision and administration department at the districted municipal level."。

If the goods you sell are Class II medical devices，Then you need to register the qualifications for Class II medical device products when publishing.。Taobao stores that have been registered，In the future, only products with the same business scope as the registered Class II medical device registration certificate will be released.。

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