Measures for the Supervision and Administration of Medical Device Production

Measures for the Supervision and Administration of Medical Device ProductionContent formulated to strengthen the supervision and management of medical device production, standardize medical device production behavior, and ensure the safety and effectiveness of medical devices. The free version of the Medical Device Production Supervision and Management Measures is provided by Huajun Software Park for free download. The source file is in docx format, which is convenient for users to edit by themselves. For more information about medical device production supervision and management measures, please pay attention to Huajun Software Park for free downloads.

Contents of the Measures for Supervision and Administration of Medical Device Production

(1) Have production sites, environmental conditions, production equipment and professional and technical personnel suitable for the production of medical devices

(2) Have an institution or full-time inspection personnel and inspection equipment that conducts quality inspection of the medical devices produced

(3) Have a management system to ensure the quality of medical devices

(4) Have after-sales service capabilities suitable for the medical devices produced

(5) Documents that meet product development and production process requirements

Elements of Medical Device Production Supervision and Management Measures

​​Medical device manufacturing enterprises should conduct production at approved or registered production sites, maintain production equipment, process equipment, inspection instruments and other facilities and equipment to ensure their normal operation.

​​Medical device manufacturers should strengthen procurement management, establish a supplier review system, evaluate suppliers, and ensure that purchased products meet legal requirements.

Medical device manufacturers should record the procurement, production and inspection of raw materials. Records should be true, accurate, complete, and meet traceability requirements.

The state encourages medical device manufacturers to adopt advanced technical means and establish information management systems.

If a major quality accident occurs in a medical device manufacturing enterprise, it should report to the food and drug regulatory department of the local province, autonomous region, or municipality directly under the Central Government within xx hours. The provincial, autonomous region, or municipal food and drug regulatory department should immediately report to the China Food and Drug Administration.

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