On May 23, the Guangdong Provincial Drug Administration held a press conference to introduce the recently issued "Several Measures of the Guangdong Provincial Drug Administration on Optimizing the Approval of the Second Class of Medical Device Registration and Approval" (hereinafter referred to as "Several Measures"), Guangdong Su Shengfeng, a first -level inspector of the Provincial Drug Administration, introduced the main purpose, main content, and main characteristics of "Several Measures".

There are 20 parts of "Several Measures". The main contents include: the first is to optimize the process and achieve comprehensive acceleration. Product registration technology review time limit is increased by more than 50%compared to the statutory time limit, and the time limit for administrative approval will be accelerated by 50%. Category standard product inspection cycle, open inspection time limit and progress, and strengthen inspection time limit supervision. Followed by hierarchical division to improve the efficiency of handling. Optimize the acceptance service, improve the electronic declaration function, avoid repeated submission, repeated correction, and improve the quality and efficiency of declaration. Establish fast channels in inspection, testing and technical review, optimize resource allocation, and maximize the efficiency of handling. Special channels to strongly support innovation. For the implementation of special person guidance services to apply for innovation and identifying innovation, provide technical support for performance indicators evaluation and inspection methods, and provide clinical test institutions for docking and clinical trial guidance for projects that need to carry out clinical trials. Establish a research mechanism for research and review, and support innovative product companies to submit R \\u0026 D materials by rolling according to staged research progress. And simplify approval and serve the development of the industry. Under the premise of ensuring the threshold of guarantee, simplify the application materials and review content, and encourage imports and provinces to register products to be transferred to Guangdong Province. Continuously simplify and optimize on -site inspection processes to avoid repeated inspections. Establish the main document registration system to reduce the repeated evaluation and repetitive inspection of raw materials and key components. Take multiple measures to improve the efficiency of inspection. Implement the information management of the entire process, and use parallel inspection and collaborative inspection to improve the inspection efficiency. The test report issued by a third -party inspection agency with a legal qualification is used for registered inspection. Guide the standards for self -inspection reports for enterprise self -inspection reports for registration. At the same time, strengthen collaboration and improve service level. Support industrial concentration and conditional regional and provincial bureau to jointly build industrial service stations (points). Strengthen the collaboration with units and other units such as the Division of the Greater Bay Division of the Medical Devices of the State Drug Administration, and improve the review and approval capabilities. Improve the communication mechanism and strengthen the technical guidance service of the applicant.

Su Shengfeng introduced that the Guangdong Provincial Drug Administration is currently working hard to implement the requirements of the provincial government's comprehensive strengthening of drug supervision capabilities, promote the comprehensive reform of the drug supervision system and supervision capabilities, and strive to build a demonstration zone of the high -quality development of drug quality and industries in the country, and promote Guangdong to promote Guangdong Drug supervision capabilities are the first to reach the international advanced level. The main purpose of the Guangdong Provincial Drug Administration issued the "Several Measures" is to further promote the reform of the review and approval system, implement the comprehensive reform of drug supervision, and implement the high -quality development of the medical device industry.

According to reports, "Several Measures" focuses on the current bottleneck problem that restricts the development of the medical device industry in Guangdong Province, and strives for the improvement of mechanisms, standards, improvement efficiency, and optimization services. "protrude":

The first is to highlight comprehensive reform.

The implementation of the comprehensive reform of drug supervision is a major strategic deployment in the field of drug supervision. It is an active measure taken based on the new situation and requirements of comprehensive reforms and based on the new requirements of comprehensive reform. The "Several Measures" clearly adjusts the structure, model, and path of the full -link process of review and approval, and comprehensively improves the effectiveness of the registration of medical device registration in Guangdong Province through comprehensive reform, and better serve the enterprise.

The second is to highlight the target orientation.

"Several Measures" is a supporting document that connects the "Implementation Plan for the High -quality Development of the Medical Device Industry in Guangdong Province" issued by the General Office of the Guangdong Provincial Government. measure. Highlighting the goal orientation is to transform the response enterprise's demands into specific actions to achieve the goal of an average compression of 50%and stimulate the vitality and motivation of the entire industry.

The third is to highlight service leadership.

It is necessary to further promote the reform of decentralization and management service, continue to optimize the business environment, and stimulate the vitality and creativity of the market, and must provide high -quality service measures. Through more accurate and detailed services, establish a special review channel and technical service mechanism that encourages innovation to attract enterprises to turn the most advanced technology into products to land in Guangdong and enhance the sense of gain of enterprises.

The fourth is to highlight market orientation.

There are many fields of medical equipment, fast product iterations, and mergers and acquisitions are undoubtedly a fast lane for enterprise development. The rapid landing of mergers and acquisitions can allow enterprises to seize high potential market segments in a timely manner and promote enterprises to become bigger and stronger. Through simplifying the application materials and rapid approval, it not only encourages the introduction of market prospects to be introduced into production, but also supports the competitiveness of Guangdong's industrial competitiveness by transferring registered high -quality products to the province.

Fifth, highlighting efficient collaboration.

Registration of medical device involves classification, inspection, review, verification, approval and other links, and requires close connection to various departments to strengthen collaboration. Various optimization measures introduced to strengthen business collaboration between departments, and through the establishment of a business mechanism, improve the service efficiency of cross -departments, cross -links, and cross -business, and form a joint effort to promote high -quality development of the industry.

Su Shengfeng said that in the next step, the Guangdong Provincial Drug Administration will strengthen organizational implementation, refine supporting plans, form a joint force of reform, and solidly promote the optimization review and approval. Carry out the efficiency assessment of the full process in a timely manner, with problems -oriented, and in terms of target progress requirements to ensure the implementation of various measures, so that enterprises can truly feel more efficient services. The quality and safety of Guangdong medical equipment is more guaranteed.