2025Guidelines for retail registration of Class II medical devices in Shenzhen

2025Shenzhen Class II Medical Device Retail Registration Guidelines in 2025 Shenzhen Class II Medical Device Retail Registration Guidelines in 2025, according to multiple media reports，The approval of the "Drug Business License" of Yijie Convenience Store under Sinopec Group is in progress。According to data from the China Chain Store and Franchise Association，There are approximately 25,700 EasyJet convenience stores nationwide.，Ranked No. 1 in the convenience store industry。

And this is also after the Beijing Jingkelong convenience store、Watsons、Wumart、Outside Suning，Another outside capital enters the pharmacy market。Favorable policies have made convenience stores and large supermarkets compete with pharmacies for the retail market as an important development goal in the future.。After convenience stores entered the pharmaceutical retail industry，It will undoubtedly have an impact on traditional pharmacies.。Coupled with "4+7" volume purchasing、A series of policies such as "certification" for pharmacists were introduced，This makes the operation of traditional pharmacies even worse.。

Some analysts pointed out，Convenience store chain groups are coming，By then, the RMB 400 billion pharmaceutical retail market structure will have undergone tremendous changes.，This undoubtedly affects the country’s 450,000 retail pharmacies，Especially for companies that do not yet have the support of pharmaceutical service capabilities，will be a great challenge。

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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