The Guide for the Establishment of National Standards in 2023 was released! Standards related to medical devices

In February 21, 2023, the official website of the National Standards Commission published the 2023 National Standards Project Guidelines (hereinafter referred to as the Guidelines). The mandatory national standards, recommended national standards and key project areas of national standard samples have been clarified, and specific requirements have been made for application requirements and materials, including related standards of medical devices, which deserve attention.

The Guideline identifies key areas of support from three aspects: mandatory national standards, recommended national standards and national standard samples.

Key areas of support for mandatory national standards include primary product safety standards, industrial product safety standards, resource and environmental safety standards and public safety standards. Among them, the safety standards of industrial products involve the establishment of mandatory national standards for the safety of medical devices.

The recommended national standards focus areas of support include: agriculture and rural areas, consumer goods and food, medical and health care, and 14 other key areas of support. Among them, in the field of medical health, it involves the establishment of the recommended national standards for high-end medical equipment industry and application, medical protective devices and other medical devices.

In addition, the guideline also specifies the application requirements and application materials for national standard project initiation.

In the application requirements for the establishment of national standards, the collection, selection and application of mandatory and recommended national standard projects, as well as the periodic management of the establishment of standards, have been clearly explained.

Compared with 2022, the declaration requirements for 2023 national standards emphasize the compatibility of Chinese standards with the international standard system.

At the same time, it encourages national standard making and revision projects to declare and promote the making and revision of foreign language versions at the same time.

In the declaration of materials, the declaration of the national standard project must be through the “national standard system revision work management information system” to fill in the electronic materials.

Application materials shall include: standard system table, project proposal, draft of standard, pre-study materials and project declaration documents.

Compared with 2022, 2023 national standard project declaration pre-research materials required to provide a more complete project declaration, in addition to the necessity and feasibility of formulating national standards, also need to provide domestic and foreign standards, the degree of consistency with international standards, major technical requirements and budget, fill in the work plan, In accordance with the revision cycle, specific time arrangements for drafting standards, soliciting comments, reviewing and submitting for approval are detailed.

For mandatory national standards, the project declaration should also state the recommended standards supporting the mandatory national standards (give a list of supporting standards), the supervision and administration department for the implementation of mandatory national standards and the relevant laws, administrative regulations and departmental rules for dealing with violations of mandatory national standards. The catalogue of products, processes or services involved in compulsory national standards, and the information on soliciting relevant departments under The State Council, etc.

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Source：Deviice Market

Translated & edited：Bradyknows