China Youth Daily client Guangzhou, May 23 (China Youth Daily, China Youth Daily reporter Lin Jie) “The time limit for technical review of product registration has been increased by more than 50%, which has stimulated the vitality and motivation of the entire industry.” Today, Guangdong Su Shengfeng, a first-level inspector of the Provincial Drug Administration, revealed that the comprehensive optimization and acceleration of medical device registration review and approval, measures to support innovation run through the entire chain of product declaration, and review and approval resources are given priority to innovative products.
Recently, “Several Measures of Guangdong Provincial Drug Administration on Optimizing the Review and Approval of Class II Medical Device Registration” ( “Several Measures” for short) was introduced, and 20 measures focused on solving the current bottlenecks restricting the development of the medical device industry in Guangdong Province, and building an efficient and high-quality medical device registration review from the aspects of improving mechanisms, standardizing standards, improving efficiency, and optimizing services. approval system.
It is understood that the Guangdong Provincial Drug Administration has reviewed the data for the past three years and found that some products with simple structure, mature production process, review guidelines, and low clinical application risk do not take long to review. , the long certification period is because the waiting time for review is long, which brings a bad experience to the enterprise.
Su Shengfeng said that the “Several Measures” is a supporting document to connect with 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. Its prominent goal orientation is to turn responses to corporate demands into concrete actions to achieve an average reduction of 50%, with strong pertinence and operability.
“Several Measures” clarifies that “one-to-one” technical guidance shall be implemented for projects that apply for special approval procedures for innovation. If the product classification is clear and the clinical evaluation evidence is sufficient, only the product implementation standards and inspection reports may be reviewed during the technical review, and the time should not exceed 5 working days.
In addition, for the projects that belong to the national, Guangdong Provincial Party Committee and Provincial Government’s medical device industry development policy support direction and the new projects declared for the first time in the province, they are included in priority approval, separate queue, priority inspection and registration verification , review and approval, and promote the accelerated listing of projects. At the same time, we will speed up the improvement of the shortcomings of high-end medical equipment, accelerate the research on key core technologies, break through the bottleneck of technical equipment, and improve the overall technical level of the industry.
Qu Nan, Director of the Administrative Licensing Division of the Guangdong Provincial Drug Administration, introduced that they have sorted out some products and situations that can be included in the simplified review process, such as masks, protective clothing, dentures, quality control products, calibration products etc., by establishing a product catalogue for the simplified review process, clarifying the circumstances in which the simplified review is applicable, setting up a separate review channel, and implementing a rapid review.
In the next step, the Guangdong Provincial Drug Administration will conduct a full-process performance evaluation in a timely manner, so that enterprises can truly experience more efficient services. At the same time, through the establishment of a consultation mechanism, the service efficiency of cross-department, cross-link and cross-business will be improved, and a joint force to promote the high-quality development of the industry will be formed.
Photo courtesy of Guangdong Provincial Drug Administration
Source: China Youth Daily client