I. Platform service content
The services provided by Tianjin Medical Device Enterprise Service Platform cover the whole process of medical device enterprises from start-up to growth. Specifically including:
1. Policy consultation service: The platform provides the latest policy interpretation and consultation to help enterprises understand policy trends and seize market opportunities.
2. Market access service: assist enterprises to complete the relevant procedures of market access, including product registration and filing, so as to reduce the difficulty of enterprise market access.
3. Quality inspection service: provide product quality inspection service for enterprises to ensure that product quality meets the requirements of relevant standards and regulations.
4. Scientific and technological innovation service: build a docking platform for innovative resources such as enterprises, scientific research institutions and universities, and promote the deep integration of Industry-University-Research.
5. Talent training service: carry out training activities in the medical device industry to improve the professional quality and ability of enterprise employees.
Two. Advantages and characteristics of the platform
Tianjin medical device enterprise service platform has the following advantages and characteristics:
1. Strong resource integration capability: the platform integrates government, industry and social resources, provides one-stop services for enterprises, and reduces the operating costs of enterprises.
2. Professional service team: The platform has a professional service team with rich industry experience and professional knowledge, which can provide tailor-made service solutions for enterprises.
3. Information sharing mechanism: The platform has established an information sharing mechanism to help enterprises keep abreast of market changes and trends by regularly publishing information such as industry trends and policy interpretations.
To sum up:
Tianjin medical device enterprise service platform is a comprehensive service platform integrating policy consultation, market access, quality inspection, technological innovation and personnel training. By integrating various resources, the platform provides all-round services for enterprises, reduces their operating costs and enhances their market competitiveness. At the same time, the platform also has strong resource integration ability and professional service team, which can provide tailor-made service solutions for enterprises and promote the healthy development of enterprises.
Legal basis:
Regulations of People's Republic of China (PRC) Municipality on the Supervision and Administration of Medical Devices
Article 8 provides that:
The state implements classified management of medical devices according to the degree of risk.
Article 9 provides that:
The state implements a classified registration and filing system for the management of medical devices.
People's Republic of China (PRC) product quality law
Article 13 stipulates:
Industrial products that may endanger human health and personal and property safety must meet the national and industrial standards for protecting human health and personal and property safety; Where national standards and industry standards are not formulated, they must meet the requirements of safeguarding human health and personal and property safety.