Circular of Neonatal Medicine Branch of China Association for Medical Devices Industry on Collection of Proposals for Preliminary Project Establishment of Group Standards 2019

  • 2019-01-21
To all institutions concerned,
In recent years, the neonatal medical technology grows rapidly, increasing new products and technologies have been applied to the neonatology. However, the standards on the product technologies, methods and management are not updated as quick as the technology growth. As a result, to implement the newly revised Methods for Medical Device Standard Management and Regulations on Group Standard Management, and to establish the project for revising group standards 2019, according to the plan of Neonatal Medicine Branch of China Association for Medical Devices Industry (CAMDI), we hereby call for proposals for preliminary project establishment of group standards 2019. The details and requirements are as follows:
I. Collection of Planned Standards
(I) Scope: medical devices, spare parts, medical technology, and management specifications applied in neonatal department;
(II) Types: basic standard, method standard, management standard and product standard;
(III) Requirements/Principle:
1. The project shall focus on industry development, scientific and technological innovation and regulation requirements, and allow for the implementation of major national policies and regulations. Priority should be given to top-level design of the standard system, the systematicness and integrity of the project, and the coordination with laws, regulations and current standards;
2. The adoption of international standard or advanced oversea standard shall comply with applicable China policies and the progress of such standards shall be specified;
3. The project shall be representative and fall within the business scope and area of expertise of the applicant. And it shall reflect the advanced domestic level and be capable of verifying applicable standards;
4. Where there is no national standard, industry standard or international standard, the project shall focus more on the industry besides the enterprise demands, and it shall contribute to the industry development and improved enterprise competitiveness;
(IV) Proposer: any institution or individual may suggest establishing the project on developing and revising standards to the secretariat of the standard commission. The proposal put forward by individual shall be applied by an institution recommended by the proposer or designated by the secretariat.

Neonatal Medicine Branch of China Association for Medical Devices Industry

January 16, 2019