Laws and regulations of medical special equipment

The Law on Safety of Special Equipment stipulates that special equipment refers to pressure vessels, elevators, lifting machinery and other equipment that may endanger personal and property safety during use and need to undergo special safety supervision and management and obtain a license. Units and individuals engaged in the production, installation, renovation and maintenance of special equipment shall have corresponding qualification certificates or vocational skills certificates.

The Law on Safety of Special Equipment is the basic law in the field of special equipment in China, which has been implemented since 20 14. According to the law, special equipment refers to pressure vessels, elevators, hoisting machinery and other equipment that may endanger personal and property safety during use, and need to be subject to special safety supervision and management and obtain the use license. The production, installation, modification and maintenance of special equipment must also be managed and controlled by professionals to ensure the safety performance and reliability of the equipment. According to the Special Equipment Safety Law, the design, manufacture, installation, modification, repair, inspection and appraisal of special equipment must comply with national standards and relevant laws and regulations. Units and individuals engaged in the production, installation, renovation and maintenance of special equipment must have corresponding qualification certificates or vocational skills certificates. At the same time, special equipment needs special inspection and appraisal to ensure that it meets the requirements of national standards and safety regulations before it can be put into use. The Law on Safety of Special Equipment puts forward specific requirements for the safety supervision and management of special equipment, including the establishment of safety supervision institutions, the establishment of safety supervision systems, and the strengthening of accident emergency management. The law also stipulates the training and assessment requirements for employees of special equipment, and clarifies the legal responsibilities involved in accidents caused by violations of safety regulations.

What is the process of handling special equipment licenses? Relevant materials need to be submitted when handling special equipment license, including basic information of special equipment, qualification certificate of user, safety status report of special equipment, etc. The applicant shall provide complete, true and accurate materials according to the actual situation, and accept the inspection of relevant departments. After passing the examination, the license will be issued, and the installation, debugging and acceptance of the equipment will be completed within the specified time.

The implementation of the Law on Safety of Special Equipment provides legal support and guidance for the management and supervision of special equipment in China. Units and individuals engaged in special equipment related work shall have professional quality and skills, abide by national standards and laws, and ensure the safety and reliability of special equipment. At the same time, it is necessary to strengthen safety supervision and accident emergency management to prevent accidents and maintain public safety and social stability.

Legal basis:

Article 13 of the Law of the People's Republic of China on the Safety of Special Equipment: Units that produce, operate and use special equipment and their principal responsible persons shall be responsible for the safety of the special equipment they produce, operate and use. Units that produce, operate and use special equipment shall be equipped with special equipment safety management personnel, testing personnel and operating personnel in accordance with relevant state regulations, and provide them with necessary safety education and skills training.