Analysis on the basic attributes and positioning of rehabilitation equipment standard in the new era

2023-09-14

From the historical process of standardization development in China, standardization has always been a basic system for the modernization of national governance system and governance capacity. Standardization has played an important role in guaranteeing and providing technical support in improving product quality, standardizing market order, developing foreign trade, and promoting the sustained, rapid and healthy development of the national economy. The standardization work of rehabilitation equipment has experienced the "eleventh Five-Year Plan" to the "thirteenth Five-Year Plan", and has achieved leapfrog development in the construction of standard management regulations, organizational structure construction, and standard system construction. In recent years, the national standardization reform and the reform of the rehabilitation equipment regulatory system continue to advance, the rapid development of the rehabilitation equipment industry and the increasing demand for people's equipment, in the face of the new situation and new needs, a correct understanding of the basic attributes and positioning of rehabilitation equipment standards, scientific development, understanding and implementation of rehabilitation equipment standards, It is important to make it better serve and support the supervision and industry development of rehabilitation devices.

Basic attributes of rehabilitation equipment standards

In a broad sense, as long as there is a unified state, there must be its standards, such as behavioral standards, aesthetic standards, moral standards. What we usually call a standard is actually a document standard, that is, a textual standard managed by a specific body. "Measures for the Management of rehabilitation equipment standards" stipulates: "Rehabilitation equipment standards refer to the unified technical requirements followed by the State Food and Drug Administration in the development, production, operation, use, supervision and management of rehabilitation equipment, which are organized and revised by the State Food and Drug Administration according to its responsibilities, issued according to the prescribed procedures." According to this definition, the rehabilitation instrument standard, as a documented standard, has the following four basic attributes.

■

9 policies of the medical device industry in the first half of 2016

2023-09-03