[Electronic regulation mode on implantable medical device]

Area of Science:

• Medical Device Regulation
• Public Health Policy
• Information Systems

Context:

• The implantable medical device industry faces challenges due to information asymmetry.
• Improper industry behavior stems from untruthful and incomplete data.
• Current supervision methods require reform to ensure safety and transparency.

Purpose:

• To explore methods for reforming implantable medical device supervision.
• To propose an electronic monitoring system for enhanced oversight.
• To address information gaps and promote market order.

Summary:

• Literature review, comparative study, situational analysis, developmental study, and case studies were employed.
• Findings indicate that untruthful and asymmetric information drives improper conduct in the implantable medical device sector.
• An electronic monitoring system with independent, interconnected, real-time databases is proposed.

Impact:

• Guarantees open and transparent implantable medical device information.
• Eliminates the transmission of false information.
• Vindicates good order within the domestic implantable medical device industry.
• Protects the vital interests of the public.