Chinese site master file

Site Master File List (for medical devices)

1 Overall Company Situation

1.1 Contact Information

Company Name:

Registered Address:

Contact Information (including 24-hour contact number in case of product defects or recalls):

1.2 Basic Company Information

Brief History:

Address of the Production Factory (if there are multiple addresses, they should be listed one by one and matched with the production process flow chart of the inspected product):

1.3 Company Product Information

1.3.1 Name and registration number of the product that has obtained the registration certificate (certificate attached)

1.3.2 Name and acceptance number of the product under review

2 Company Quality Management System

2.1 Briefly describe the operation of the company's quality management system and the standards adopted

2.2 Responsibilities of the top management and senior management in the quality management system

2.3 Briefly describe the factory's acceptance of medical device quality system inspections in the past two years: inspection time, inspection agency and inspection conclusions, etc.

3 Supplier and Contractor Management

3.1 Briefly describe the company's supplier requirements and their audits

3.2 Briefly describe contractors and their control measures

Entrusted/contracted production, entrusted/contracted inspection and entrusted matters, responsibilities of the entrusting party and the entrusting party in product release

List of entrusted/contracted production enterprises (inspection laboratories), including address and contact information

4 Personnel

4.1 Factory organization chart/quality organization chart

4.2 Names and positions of senior managers

4.3 Number of personnel engaged in quality management, production operations, and quality inspection

4.4 Brief description of personnel training and health management

5 Factory buildings and facilities

5.1 Production plant situation

5.1.1 Production plant area

5.1.2 Functional use and area of ​​each factory building

5.1.3 Production plant floor plan

5.2 Production area situation

5.2.1 Production area floor plan

5.2.2 Clarify the process flow involved in each area

5.2.3 Clarify Cleanliness level of each area

5.3 Storage area

5.3.1 Storage area function

5.3.2 Storage area area

5.3.3 Special storage conditions

5.4 Air conditioning purification system

5.4.1 Air supply and return air

5.4.2 Temperature, humidity, pressure difference

5.5 Water system

5.5.1 Purified water, water for injection

5.5.2 Water quality standard

5.6 Briefly describe other public facilities, such as steam, compressed air, nitrogen, etc.

6 Equipment

6.1 Briefly describe the main production processes and equipment used related to the inspected varieties;

6.2 Briefly describe the main inspection items and inspection equipment related to the inspected varieties;

6.3 Computer system

7 Files

Briefly describe the file control system. (If the files and records are stored outside the production plant, please provide the external file/record directory, storage place name and address, and the time required to retrieve the files from outside the factory.)

8 Production

8.1 Production process flow chart and brief description of the inspected varieties (including cleanliness level/contract production/inspection, etc.).

8.2 Principles of rework or reprocessing

9 Material storage management

9.1 Control of raw and auxiliary materials, parts, semi-finished products and finished products.

9.2 Status identification, area division, and management of defective products

10 Quality control

10.1 Briefly describe quality control activities such as physical, chemical, microbiological and biological tests

10.2 Process inspection

10.3 Finished product inspection and release

10.4 Sample retention

11 Sales, complaints, product defects and recalls

11.1 Briefly describe product sales methods and after-sales services, and methods and measures to ensure product traceability

11.2 Briefly describe complaint handling, product defects and recall procedures

12 Internal audit

Briefly describe the company's internal audit, management review and CAPA related situations

13 Briefly describe the company's product R&D management situation



14 Data authenticity statement