On May 23, Guangdong Drug Administration held a press conference to introduce the main purpose, main contents and main characteristics of the recently issued “several measures of Guangdong Drug Administration on optimizing the registration, review and approval of class II medical devices” (hereinafter referred to as “several measures”).
Su Shengfeng, a first-class inspector of Guangdong Drug Administration, introduced that the main purposes of the “several measures” are: first, to further promote the reform of the review and approval system, second, to practice the comprehensive reform of drug supervision, and third, to implement and promote the high-quality development of the medical device industry.
The “several measures” has four parts and 20 articles. The main contents are as follows: first, optimize the process and realize overall speed-up. The time limit for technical review of product registration is more than 50% faster than the legal time limit, and the time limit for administrative examination and approval is 50%. Classify and standardize the product inspection cycle, disclose the inspection time limit and progress, and strengthen the supervision of inspection time limit.
Second, it is classified and divided to improve the handling efficiency. Optimize the acceptance service, improve the electronic declaration function, avoid repeated submission and correction, and improve the quality and efficiency of declaration. Establish a fast track in inspection, testing and technical review, optimize resource allocation and maximize handling efficiency.
Third, special channels to vigorously support innovation. Implement special guidance services for products applying for innovation and identifying innovation, provide technical support for performance index evaluation and test method verification, and provide services such as connection of clinical trial institutions and guidance of clinical trial scheme for projects requiring clinical trial. Establish a research review linkage mechanism to support innovative product enterprises to submit R & D materials according to phased research progress.
Fourth, simplify examination and approval and promote the development of service industry. On the premise of ensuring that the threshold is not lowered, simplify the application materials and review contents, and encourage imported and registered products from other provinces to be transferred to Guangdong Province. Continuously simplify and optimize the on-site verification process to avoid repeated inspection. Establish a master document registration system to reduce repeated evaluation and inspection of raw materials and key components.
Fifth, take multiple measures to improve the inspection efficiency. Implement the information management of the whole inspection process, and adopt parallel inspection, collaborative inspection and other methods to improve the inspection efficiency. Support the inspection report issued by a legally qualified third-party inspection institution for registration inspection. Guide and standardize enterprise self inspection reports for registration and declaration.
Sixth, strengthen cooperation and improve service level. Support industrial concentration and qualified regions and provincial bureaus to jointly build industrial service stations (points). Strengthen cooperation with Dawan sub center for technical review and inspection of medical devices of the State Food and Drug Administration and other units to improve the review and approval ability. Improve the communication mechanism and strengthen the technical guidance service to the applicant.
The “several measures” focus on solving the bottleneck problems restricting the development of medical device industry in Guangdong Province, and strive to build an efficient and high-quality medical device registration, review and approval system from the aspects of improving mechanism, standardizing standards, improving efficiency and optimizing services.
In terms of highlighting market orientation, Guangdong food and Drug Administration said that there are many subdivided fields of medical devices and the product iteration speed is fast. M & A is undoubtedly a fast lane for enterprise development. The rapid implementation of M & A projects can enable enterprises to seize high potential market segments in time and promote enterprises to become bigger and stronger. By simplifying the application materials and rapid approval, we not only encourage the introduction of listed imported products with market prospects into production, but also support the transfer of registered high-quality products into the province to enhance the industrial competitiveness of Guangdong Province.
In the next step, Guangdong food and Drug Administration will strengthen the organization and implementation, refine the supporting scheme, form a joint force of reform, and solidly promote the optimization of review and approval. Timely carry out the efficiency evaluation of the whole process, take the problem as the guide, compare the target progress requirements item by item, ensure the implementation of various measures, make the enterprise feel more efficient service, and ensure the quality and safety of medical devices in Guangdong Province.
