What is the significance of the medical device classification and regulatory system?

Published time:

2025-04-25 11:23

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Ensuring patient safety
Reducing risks of use: Different categories of medical devices have different risk levels, scopes of use, and regulatory requirements. Through scientific and reasonable classification definitions, it can be ensured that medical devices undergo sufficient research and evaluation before they are put on the market, reducing risks during patient use. Improving product quality: The classification and supervision system requires medical device manufacturers to obtain product registration certificates and production licenses, and also to undergo Good Manufacturing Practice (GMP) certification, which helps improve the production quality and safety of medical devices.
Promoting industry development
Promoting innovation: Reasonable classification can guide corporate research and development directions, encourage corporate innovation, and improve product quality and competitiveness. At the same time, classification definitions can also help companies understand market trends, adjust industrial structures, and provide strong support for industrial development.
Optimizing resource allocation: Through classification management, regulatory agencies can formulate corresponding regulatory policies and measures for different categories of medical devices, achieving refined management, reducing regulatory costs, and improving regulatory efficiency. This helps optimize regulatory resource allocation, allowing regulatory agencies to focus more on the regulation of high-risk products.
Improving regulatory efficiency
Clarifying the subject of regulation: The classification and supervision system clarifies the regulatory requirements and regulatory bodies for different categories of medical devices, allowing regulatory agencies to carry out regulatory work in a targeted manner and improve supervision
efficiency.
Reducing repetitive work: Through classification definitions, it is possible to avoid repeated evaluation and review of the same product, reducing repetitive work and costs for regulatory agencies and enterprises