2025New regulations on filing conditions for Shenzhen’s application for Class II medical device operations

2025New Regulations on the Conditions for Applying for Class II Medical Device Operation Recording in Shenzhen How to Apply for Class II Medical Device Operation Recording in Shenzhen in 2025 How to Apply? Shenzhen Class II Medical Device Business Registration，This article mainly introduces the procedures for filing Class II medical devices.

Require

and required preparation materials。

one、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.。

two、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、Copy of professional title certificate and relevant personnel (wholesale company：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。

three、Shenzhen Class II medical device registration submission materials

Require

1. Filing materials should be complete、clear，Printed and bound on A4 paper with catalog，The copy must be stamped with the official seal and submitted together with the electronic version.。
2. Company name、legal representative、Business person in charge、Quality manager、Business scope、business address、Warehouse address and other filing matters change。
3. If the company name is changed、Legal representative of the enterprise、of the person in charge of the enterprise，should be submitted：legal representative、Identity certificate of the person in charge of the company，Education certificate or professional title certificate；A copy of the changed Industrial and Commercial Business License；
4. If the company’s business address is changed，A floor plan of the business premises is required.、House property rights certificate or lease agreement (with house property rights certificate attached)、Geographical location map。
5. If the business scope is changed、Change warehouse address，Warehouse floor plan is required、House property rights certificate or lease agreement (with house property rights certificate attached)、Geographical location map、Warehouse Facilities and Equipment Catalog。
6. If the quality manager is changed，It is necessary to provide the academic qualifications of the proposed quality manager、Professional title certificate、Copy of ID card。
7. Such as those dealing in in vitro diagnostic reagents,The quality manager must be someone with the title of supervisory inspector.，And need to provide relevant cold chain facility certification materials。Such as standby generator sets or standby refrigeration units、Automatic temperature controller、Automatic alarm equipment、Invoices for refrigerated trucks etc.，Cold storage installation contract、Operation certificate, etc.。If the above conditions cannot be provided，The business scope is "6840 in vitro diagnostic reagents (except products requiring cold chain management)"。
8. Hearing aid operating companies，Corresponding fitting facilities and equipment (such as hearing testing rooms) need to be provided、Fitting room，Hearing test equipment or instruments, etc.) and technical personnel with primary hearing test professional qualifications。 The above is about the registration of Class II medical devices in Shenzhen

Require

and introduction of materials。

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