I. Registration
The new regulations in 2024 put forward higher requirements for the registration of medical devices, including strengthening the management of pre-registration clinical trials to ensure the authenticity and reliability of the test data; at the same time, the review of the registration application materials will be more stringent to prevent non-compliant medical devices from entering the market.
Second, the production link
In the production link, the new regulations require medical device manufacturers to establish a comprehensive quality management system, and strengthen the quality control of raw materials, production process, finished product inspection and other aspects. In addition, manufacturers are required to regularly report production to the regulatory authorities, so that regulators can keep abreast of production dynamics and ensure the quality and safety of medical devices.
Three, the operation
For the operation of medical devices, the new regulations will strengthen the qualification of operators and daily supervision. Operators need to have the appropriate qualifications and conditions in order to engage in the operation of medical devices. At the same time, the regulatory authorities will also strengthen the supervision and inspection of the medical device market to combat counterfeiting, unlicensed operation and other illegal acts.
Fourth, the use of the link
In the use of the link, the new regulations require medical institutions to establish a comprehensive medical device management system, to ensure that the procurement, acceptance, use and maintenance of medical devices in accordance with the provisions of the link. In addition, medical institutions also need to strengthen the training and management of medical staff to improve their skills in the use of medical devices and safety awareness.
In summary:
The new 2024 medical device regulations impose stricter requirements in registration, production, operation and use, aiming to ensure the safety and effectiveness of medical devices. The implementation of these regulations will help regulate the medical device market and protect the public's health rights.
Legal basis:
Regulations on the Supervision and Administration of Medical Devices
Article 6 states:
The state implements the classification and management of medical devices according to the degree of risk. Evaluation of the degree of risk of medical devices should take into account factors such as the intended purpose, structural characteristics, and methods of use of medical devices.
Regulations on the Supervision and Administration of Medical Devices
Article 7 provides:
The state shall implement product registration management for medical devices. Medical device registrants, filers should strengthen the quality management of medical devices throughout the life cycle, the development, production, operation and use of the whole process of medical device safety and effectiveness of responsibility according to law.
"Regulations for the Supervision and Administration of Medical Devices"
Article 8 states:
The state improves the medical device innovation system, supports the basic and applied research of medical devices, promotes the popularization and application of new technologies in medical devices, and promotes the high-quality development of the medical device industry.