2025Shenzhen optimizes medical device business license application process

2025Shenzhen optimizes medical device business license

Application process

Recently, the Shenzhen Market Supervision and Administration Bureau has further optimized the business environment.，Facilitate enterprises to apply for medical device business license (recording) business. The medical device business license (recording) business process has been optimized and upgraded since July 1, 2025.。

in subsequent supervision，Corporate credit supervision will be strengthened，If it is found that the information submitted by the company is untrue，Will be dealt with according to the result of submitting false materials to defraud administrative license/filing。"Class II Medical Device Business Registration Certificate"、The "Third Class Medical Device Business License" implements electronic licenses，The electronic official seal is stamped on the electronic certificate。After approval，Enterprises can download and print electronic certificates online，QR code in electronic certificate can be used to verify authenticity。

If the enterprise really needs paper certificates due to special circumstances,，You can also print paper certificates at the district bureau window where your business place is located.。The information required to apply for a medical device business license needs to be distinguished according to the categories of medical devices you operate.，Operating Class I medical devices does not require licensing or registration，The operation of Class II medical devices shall be subject to registration management，License management is implemented for operating Class III medical devices。

Business registration information for Class II medical devices

Require

：

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、Copy of professional title 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. Certificate of authorization of the person in charge；
9. Other supporting materials。

According to the implementation details of "Beijing's "Measures for the Supervision and Administration of Medical Device Operations"

Require

，The information required to apply for the second-class medical device business registration certificate is as follows:：

1. "Class II Medical Device Business Registration Form"/"Medical Device Business License Application Form"
2. Copy of the company's "Business License"
3. legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate；
4. The organizational structure and functions of the proposed enterprise or the functions of full-time quality management personnel。
5. Proposed business premises、Geographical location map of warehouse address、floor plan、Property ownership certificate and lease agreement，Different offices may require original copies.，Subject to on-site。
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. When applying for enterprise application materials，The specific person handling the matter is not the legal representative or the person in charge himself，Businesses should submit；For pharmacies engaged in the retail business of medical devices，Business enterprises do not need to set up separate warehouses，However, the storage environment should meet the medical device label、Conditions marked in the instructions

Require

。

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