Threshold lowered! Medical device review and approval policy relaxed!
On March 21,2023, in order to further promote the high-quality development of the medical device industry, Zhejiang Provincial MPA formulated and issued the Implementation Opinions on Optimizing the Review and approval of Medical device Registration (later called Implementation
Opinions), focusing on innovative review and approval service methods, improving the quality and efficiency of review and approval, and continuously reducing enterprise registration costs.
The Implementation Opinions includes 23 specific opinions in 5 aspects, including comprehensively improving the efficiency of review and approval, further optimizing the review and approval process, vigorously supporting innovation priority projects, improving the efficiency of inspection and testing through multiple channels, and comprehensively improving the level of licensing service. Enterprises have more expectations for the continuous optimization of the review and approval policies of medical devices, among which the most concerned is to shorten the review time limit and reduce registration fees.
#01 Shortening the review and approval time limit
It is proposed in the Implementation Opinions that from March 1,2023, the average time limit of technical review for the first registration, change registration and extension registration of the Class II medical devices in Zhejiang will be reduced from 120 working days to 50 working days; Aim for a further reduction to 40 working days by 2024; At the same time, the time limit for administrative approval will be reduced from the statutory 20 working days to 5 working days.
#02 Reduceing registration fees
On the basis of the two previous fee reductions, the Implementation Opinions will charge the registration, change registration and extension registration fees of medical device products according to 70% of the current standard. The first registration fee is 46,011 yuan/variety, the change registration fee is 15,405 yuan/variety, and the extension registration fee is 15,288 yuan/variety. In other words, the first registration fee is 49% of the initial 2016 standard, and the change and renewal fee is 39.2% of the initial 2016 standard.
It is worth mentioning that the Implementation Opinions also put forward that the products that meet the requirements of special approval, priority approval and emergency approval of innovative medical devices can open up green channels and strengthen guidance services, which means that the “advanced, sophisticated” medical device project in Zhejiang can be quickly put on the market to meet clinical needs and seize the market opportunity.
According to reports, since the official implementation of the “Implementation Opinions” on March 1, the province has accepted 73 initial registrations of medical devices,23 extended registrations and 17 changed registrations within 20 days, with a total reduction of registration fees of over 1.7 million yuan.
In addition, on March 17,2023, Guangdong Provincial MPA released the Report on Medical Device Registration in Guangdong Province in 2022. According to the Measures on Optimizing the review and Approval of the Class II of Medical Device Registration issued by Guangdong Provincial MPA in 2022, it proposed to optimize the review service, improve the review mechanism by different routes, and optimize the on-site inspection process. Unified technical evaluation standards, detailed supporting measures and other 20 measures, it has also issued Guidelines on Registration and Application of Listed Class II Medical Devices Moving into our Province (Trial), Requirements for Acceptance and Examination of Registration Certificate of Class II Medical Devices (in vitro Diagnostic Reagents), Notice on the Implementation of Main Document Registration of Medical Devices, Work Guidelines on Medical Device Inspection, and Twelve Articles of Excellent Inspection, etc. It has comprehensively accelerated the listing approval process of Class II medical devices in Guangdong Province.
It can be seen that in order to help the medical device industry further break away from the “low scattered” situation; At the same time, further encourage and support innovation, which is conducive to the rapid approval of “high-end, sophisticated” medical device projects and meet clinical needs. Several provinces are simultaneously exploring the optimization of medical device review and approval policies, and the reduction of the threshold is undoubtedly a significant benefit for the medical device industry.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com.
Source：Medical Device Market
Translated & edited ：Bradyknows
