What impact does the medical device classification regulatory system have on manufacturers?

Published time:

2025-04-25 11:21

Source:

The medical device classification and regulatory system has a profound impact on manufacturers, mainly in the following aspects:
Raising product registration and production requirements
Registration management differences: Class III medical devices are subject to filing management. After submitting the filing materials, they only need to meet the material requirements to pass, which is relatively simple. Class II and Class I medical devices are subject to registration management. The registration process is more complex and requires more detailed materials, including clinical evaluation data, and goes through a strict review and approval process.
Production license:
Medical device manufacturers need to obtain the corresponding production licenses and produce according to the Good Manufacturing Practice (GMP) for medical devices. Different categories of medical devices have different production license requirements and GMP standards.
Strengthening product quality and safety control
Quality control system:
The medical device classification and regulatory system requires manufacturers to establish a sound quality control system to ensure that every link from research and development, production to sales complies with relevant regulations and
standards.
Regulatory agencies will regularly inspect and evaluate the quality management system of manufacturers to ensure its continued effective operation. Adverse event monitoring and reporting:
Adverse events may occur during the use of medical devices. Manufacturers need to establish an adverse event monitoring and reporting system to promptly collect, analyze and report adverse event information in order to take corresponding risk control measures