Drugdu.com expert's response:

Class II and Class III medical devices require registration, primarily for the following reasons:

I. Regulatory Requirements

The Regulations on the Supervision and Administration of Medical Devices explicitly stipulate that Class II and Class III medical devices must undergo registration management. Medical devices that have not been registered are prohibited from being sold and used in the market. This is a fundamental principle for the standardized operation of the medical device industry, which enterprises must adhere to in order to ensure lawful business operations.

II. Risk Control

Class II medical devices carry moderate risks: Examples include thermometers, sphygmomanometers, and electrocardiographs. If there are issues with the product quality or safety, it may lead to misdiagnosis, mistreatment, or certain harm to the patient's body.

Class III medical devices pose higher risks: These include devices such as cardiac pacemakers, artificial joints, and implantable cardiac stents. These products are typically used to support or sustain life or pose potential dangers to the human body. In the event of malfunctions or quality defects, they are highly likely to endanger the patient's life. The stringent review and evaluation during the registration process can effectively mitigate risks and safeguard patient safety.

III. Quality Assurance

The registration process encourages enterprises to establish a comprehensive quality control system: During the registration process, regulatory authorities conduct a thorough review and rigorous inspection of the medical device's manufacturing process, technical performance, and quality management system. This helps enterprises ensure stable product quality and reliable performance, enabling the medical devices to achieve the expected therapeutic and diagnostic effects in clinical applications.

IV. Maintenance of Market Order

The registration system prevents unqualified products from entering the market: The registration system can effectively prevent unqualified and low-quality medical devices from entering the market, avoiding the circulation of counterfeit and shoddy products. This protects the rights and interests of legitimate enterprises, maintains a fair and competitive market environment, and promotes the healthy and orderly development of the medical device industry.

V. Facilitation of Supervision and Traceability

Registration information facilitates supervision and problem traceability: During registration, enterprises are required to provide detailed product information and manufacturer information. In the event of issues arising during the use of medical devices, regulatory authorities and enterprises can swiftly trace the product's origin, manufacturing process, and sales distribution through the registration information. This enables timely measures such as recalls and cessation of use to be taken, preventing the further escalation of problems and effectively controlling risks.