In the critical period when the medical device industry ushered in innovative development, Fujian Provincial Drug Administration took active action and recently released three new procedure documents: Fujian Provincial Special Review Procedure for Class II Innovative Medical Devices (Trial), Fujian Provincial Priority Approval Procedure for Class II Medical Devices (Trial), and Fujian Provincial Emergency Approval Procedure for Class II Medical Devices (Trial), Together, they constitute a new policy framework for the development of the medical device industry in Fujian Province. All process links in the examination and approval shall be handled in accordance with the principle of "five priorities", which will promote the "growth and upgrading" of enterprise innovation and provide a strong guarantee for the high-quality development of the medical device industry in Fujian Province.

The medical device industry is a basic and strategic emerging industry related to people's life and health. In order to further promote the reform of the review and approval system, encourage the innovation of medical devices, and deepen the supply side structural reform and the reform requirements of "decentralization, regulation, and service", the three procedures released this time have not set a transition period and are implemented immediately after release, which will bring a "shot in the arm" for enterprises and research and development institutions in the province, and will strongly promote the high-quality development of the medical device industry. The optimization of the three review procedures focuses on two aspects: shortening the time limit for approval and improving service efficiency; Expand the scope of accreditation and encourage enterprise innovation.

1、 Review and approval run out of "Fujian speed"

In order to shorten the inspection cycle of medical device products, the method of "customized approval and priority acceptance" is adopted. For medical device products with technological innovation and significant leading advantages, the registration and approval process of products is greatly shortened by means of early intervention and expert guidance, so that innovative products and clinically urgently needed products "queue up separately and run all the way".

2、 The scope of accreditation opens the "new chapter in Fujian"

The products that have been clearly defined as Class II medical devices, have technological innovation, obtained patent rights and significant clinical application value are included in the special approval for innovation, and the medical devices that are urgently needed clinically, such as rare diseases, malignant tumors, and children's special use, are included in the priority approval scope. At the same time, the emergency approval procedures for medical devices required by public health emergencies are added, Organize the inspection within 24 hours after receiving the application, and issue the report in time. Ensure that these products can be put into the market quickly to meet the urgent clinical needs.

In addition, the implementation of these procedure documents not only comprehensively promotes Fujian medical devices

Mechanical innovation and high-quality development will also bring significant benefits to medical device enterprises. Policy guidance and support will encourage enterprises to increase R&D investment, promote technological innovation and enhance product competitiveness. The simplified approval process will reduce the operating costs of enterprises and improve operating efficiency. Enterprises can accelerate the launch of innovative products through special review procedures, shorten the return cycle of R&D investment, and improve market response speed; Use the priority approval procedure to quickly respond to clinical needs and obtain differentiated competitive advantages; In the face of public health emergencies, the emergency approval procedure will provide enterprises with a rapid response mechanism to help enterprises rapidly expand their market share while ensuring that the medical devices needed for public health emergencies are listed as soon as possible.

After the official release of the three procedures, many enterprises spoke highly of them in interviews. The heads of enterprises generally said that the introduction of these three documents broke all kinds of restrictions and bottlenecks faced by enterprises in the approval process in the past. We can get point-to-point precise assistance and devote more energy to core business and innovative development. It not only enhances the market competitiveness of the enterprise, but also stimulates the enthusiasm for innovation of the enterprise, providing a solid and powerful support for the rapid development of the enterprise.

Under the guidance of policies, the medical device industry in Fujian Province will develop in a more professional, centralized and characteristic direction. By optimizing the industrial development layout, Fujian Province will build a number of characteristic biomedical industrial clusters, attract more high-end talents and innovative resources, and form large-scale industrial clusters. This will help to break foreign technology monopoly, reduce external dependence and realize industrial autonomy and controllability. At the same time, the new policy will promote the close cooperation between medical enterprises and promote the deep integration of medical enterprises. With the in-depth implementation of the policy, the medical device industry in Fujian Province will usher in a broader development prospect.

Next, Fujian Drug Administration will adhere to the concept of "serving the people, working hard and developing", conscientiously implement the three procedures and regulations, and strive to write a new chapter in the high-quality development of Fujian's medical device industry with the new responsibilities and new actions of the drug regulators in the new era, so as to contribute to the drug administration in building a new situation in Fujian's medical industry.