[China Food and Drug Network]Guangdong has introduced 20 measures to comprehensively optimize and speed up the review and approval of Class II medical device registration
China Food and Drug Network News on May 23, the Guangdong Provincial Drug Administration held a press conference to introduce the recently issued “Guangdong Provincial Drug Administration’s Measures to Optimize the Review and Approval of the Registration of Class II Medical Devices” (hereinafter referred to as “Several Measures of the Guangdong Provincial Drug Administration” “Measures”), Su Shengfeng, a first-level inspector of the Guangdong Provincial Food and Drug Administration, introduced the main purpose, main content and main characteristics of the “Several Measures”.
The “Several Measures” has 20 articles in four parts. The main contents include: The first is to optimize the process and achieve a comprehensive speed-up. The time limit for technical review of product registration is accelerated by more than 50% on average compared to the statutory time limit, and the time limit for administrative approval is accelerated by 50%. Categorize and standardize the product inspection cycle, publicize the inspection time limit and progress, and strengthen the inspection time limit supervision. The second is grading and branching to improve management efficiency. Optimize the acceptance service, improve the electronic declaration function, avoid repeated submissions, repeated corrections, and improve the quality and efficiency of declarations. Establish fast-track channels in inspection, testing and technical review, optimize resource allocation, and maximize processing efficiency. Special channel to vigorously support innovation. Provide professional guidance services for products declared for innovation and recognized innovation, provide technical support for performance index evaluation and inspection method verification, and provide clinical trial institutions for projects that need to carry out clinical trials, clinical trial program guidance and other services. Establish a research and review linkage working mechanism to support innovative product companies to submit research and development materials on a rolling basis according to the staged research progress. And simplify the approval to serve the development of the industry. On the premise of ensuring that the threshold is not lowered, the application materials and review content are simplified, and imported and registered products from other provinces are encouraged to be transferred to Guangdong Province. Continuously simplify and optimize the on-site inspection process to avoid repeated inspections. Establish a master file registration system to reduce repeated evaluation and repeated inspection of raw materials and key components. Take multiple measures to improve inspection efficiency. Implement the information management of the whole process of inspection, and adopt methods such as parallel inspection and collaborative inspection to improve the inspection efficiency. The test report issued by a third-party inspection agency with legal qualifications is supported for registration inspection. Guide and standardize enterprise self-inspection reports for registration and declaration. At the same time, strengthen cooperation and improve service level. Support the concentrated and qualified regions and provincial bureaus to jointly build industrial service stations (points). Strengthen cooperation with the National Medical Device Technology Review and Inspection Dawan District Center and other units to improve review and approval capabilities. Improve the communication mechanism and strengthen technical guidance services for applicants.
Su Shengfeng introduced that the Guangdong Provincial Food and Drug Administration is currently fully implementing the requirements of the provincial government to comprehensively strengthen the construction of drug regulatory capabilities, promote the comprehensive reform of the modernization of the drug regulatory system and regulatory capabilities, and strive to build a national demonstration area for drug quality and safety and high-quality industrial development. The drug regulatory capability has taken the lead in reaching the international advanced level. The main purpose of the “Several Measures” issued by the Guangdong Provincial Food and Drug Administration is to further promote the reform of the review and approval system, implement the comprehensive reform of drug supervision, and implement the promotion of high-quality development of the medical device industry.
According to reports, the “Several Measures” focus on solving the current bottleneck problem that restricts the development of the medical device industry in Guangdong Province, and strive to improve the mechanism, standardize standards, improve efficiency, optimize services, etc., self-pressure, and the courage to reform, which is embodied in five “protrude”:
The first is to highlight comprehensive reforms. The implementation of comprehensive reform of drug supervision is a major strategic deployment in the field of drug supervision in Guangdong. The “Several Measures” make it clear that it is necessary to adjust and optimize the structure, mode and path of the whole process of review and approval, and comprehensively improve the efficiency of medical device registration in Guangdong Province through comprehensive reforms to better serve enterprises.
The second is to highlight the goal orientation. “Several Measures” is a supporting document linking the “Guangdong Province Implementation Plan for Promoting the High-Quality Development of the Medical Device Industry” issued by the General Office of the Guangdong Provincial Government. measure. To highlight the goal orientation is to translate the response to the demands of enterprises into concrete actions, so as to achieve the goal of 50% reduction on average and stimulate the vitality and motivation of the whole industry.
The third is to highlight service leadership. To further promote the reform of delegating power, regulating services, continuously optimizing the business environment, and stimulating the vitality and creativity of market entities, it is necessary to provide high-quality service measures. Through more accurate and meticulous services, a special review channel and technical service mechanism to encourage innovation will be established to attract enterprises to convert the most advanced technologies into products and land in Guangdong, enhancing the sense of gain for enterprises.
Fourth, highlight the market orientation. There are many subdivisions of medical devices and product iterations are fast. Mergers and acquisitions are undoubtedly a fast lane for enterprise development. The rapid implementation of M&A projects enables companies to seize high-potential market segments in a timely manner, and promotes companies to become bigger and stronger. By simplifying the application materials and speeding up the approval process, it not only encourages the introduction of market-promising imported products into production, but also supports the transfer of registered high-quality products into the province for production to enhance the competitiveness of Guangdong’s industries.
Fifth, highlight efficient collaboration. Medical device registration involves classification, inspection, review, verification, approval and other links, and requires close connection and cooperation among various departments. The various optimization measures introduced focus on strengthening business synergy among various departments. Through the establishment of a consultation mechanism, the service efficiency of cross-department, cross-link and cross-business is improved, and a synergy to promote the high-quality development of the industry is formed.
Su Shengfeng said that in the next step, the Guangdong Provincial Food and Drug Administration will strengthen the organization and implementation, refine the supporting plans, form a reform synergy, and solidly promote the optimization of the review and approval work. Carry out the full-process performance evaluation in a timely manner, be problem-oriented, and compare the target progress requirements one by one to ensure the implementation of various measures, so that enterprises can truly feel more efficient services, and the quality and safety of medical devices in Guangdong Province is more guaranteed. (Chen Hairong)