Drugdu.com expert's response:

 

The application for a Class II medical device operating license must meet key requirements across four dimensions: enterprise qualifications, personnel allocation, facility conditions, and quality management systems.

I. Enterprise Legal Qualifications

Legal Person Status

The applicant must possess valid legal person status, and the enterprise must be registered with the industrial and commercial authorities and hold a valid business license.

Registered Capital and Scale

The registered capital shall generally be no less than RMB 1 million (specific amounts may vary by regional policies and should comply with local requirements).

The enterprise scale must align with its business scope to ensure capacity for fulfilling corresponding responsibilities.

Registered Address and Premises

The registered address must be an independent business venue with a floor area of no less than 80 square meters, separate from the residential address.

The operating premises must comply with national laws and regulations, providing adequate space for storing medical devices and meeting storage conditions (e.g., temperature and humidity control).

II. Personnel Allocation Requirements

Enterprise Responsible Person

Must hold a college degree or higher in a medical device-related field (e.g., biomedical engineering, medicine, pharmacy) or possess an intermediate or higher professional technical title.

Must have at least 3 years of experience in medical device operation quality management.

Quality Management Personnel

At least one qualified quality manager with a相关专业 (medical device-related) background must be assigned to implement and maintain the quality system.

The quality manager must hold a nationally recognized professional qualification or title and shall not concurrently serve as the production responsible person.

Technical Staff and Employees

A minimum of three technical personnel with medical device-related qualifications or at least 1 year of industry experience is required.

All employees must undergo professional skills training and hold valid occupational certificates.

III. Facility and Equipment Conditions

Operating Premises

Must comply with national laws and regulations, featuring independent space for storing medical devices to prevent cross-contamination.

The layout must be reasonable, with distinct functional areas (e.g., office, warehousing, inspection).

Warehousing Facilities

Must be equipped with standardized warehousing facilities, including temperature/humidity control systems and pest prevention measures.

Storage conditions must meet medical device requirements to ensure product safety and efficacy.

Operating Equipment

Must possess equipment and instruments compliant with national standards (e.g., warehouse management tools, inspection devices, office equipment).

Equipment must undergo regular calibration and maintenance to ensure proper functioning.

IV. Quality Management System Requirements

Quality Management System

Must establish a comprehensive quality management system covering procurement, inspection, storage, sales, and transportation.

Must implement and adhere to the "Medical Device Operation Quality Management Standards" to ensure compliance at all stages.

Inventory Management

Must establish an inventory management system enabling traceability of medical device origins, quality control, and accurate in/out records.

Must use a computerized information management system for dynamic inventory monitoring.

After-Sales Service System

Must establish a robust after-sales service system, including product usage guidance, technical training, and maintenance.

Must designate an after-sales service agency or专职人员 (dedicated personnel) to promptly address user needs.

Legal and Regulatory Compliance

Must comply with national laws, regulations, and policies, prohibiting illegal or non-compliant operations.

Must undergo regular inspections by drug regulatory authorities to maintain ongoing compliance.

V. Application Document Checklist

Basic Documentation

Copies of the enterprise’s business license, organization code certificate, and tax registration certificate.

Photocopies of the legal representative’s ID, academic certificates, or professional titles.

Premises and Facility Proof

Floor plan of the business premises, ownership certificate, or lease contract (with ownership certificate attached).

Inventory of business facilities/equipment and calibration/maintenance records.

Quality Management System Documentation

Quality management manual, procedural documents, and operational guidelines.

Basic information and functional descriptions of the computerized information management system.

Product and Personnel Qualifications

List of medical devices to be operated (including name, model, specification, approval number, manufacturer).

Qualification certificates and authorization letters for quality managers and technical personnel.

Other Materials

Financial statements for the past three years (balance sheet, income statement, cash flow statement).

Approval documents for work safety and environmental protection (if applicable).

This structured framework ensures compliance with regulatory standards for Class II medical device operations, facilitating a smooth licensing process.

By editor