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Class II medical device review and approval speeds up, Zhejiang industrial cluster highlights innovation advantages
Publication Time:
2025-02-16
In September 2023, the National Medical Products Administration (NMPA) issued the "Action Plan for Improving Efficiency and Quality in Medical Device Review and Approval," proposing "parallel review" for Class II innovative medical devices, reducing the average approval time from 180 days to 120 days. The Zhejiang Provincial Drug Administration launched the "Zhejiang-made Medical Devices" special action, establishing a "pre-review guidance + priority testing" mechanism to help local enterprises obtain approval quickly. Data shows that from January to November 2023, Zhejiang Province issued 1523 registration certificates for Class II medical devices, a year-on-year increase of 28%, with 20 companies, including Xinghe Medical, entering the innovative device "whitelist."
Taking Xinghe Medical's "disposable living tissue sampling forceps" as an example, this product uses a combination of nickel-titanium memory alloy skeleton and high-polymer composite materials, improving the sampling integrity rate to 95%. With the collaboration of the Zhejiang Provincial Institute of Drug Control, key steps such as biological evaluation and animal experiments were completed in just 5 months, shortening the process by 4 months compared to the conventional process. The secretary-general of Zhejiang Medical Device Industry Association pointed out: "Policy benefits are reshaping the industry landscape. Enterprises with independent R&D capabilities can obtain market exclusivity through the 'linking' system. Xinghe Medical has applied for 23 inventions in the past three years, building a significant technological barrier."
It is worth noting that while the review speed has increased, the regulatory intensity has also been strengthened. In 2023, Zhejiang Province conducted a special spot check on sterile medical devices, and 12 enterprises were ordered to rectify. Xinghe Medical received a "zero-defect" evaluation in the spot check, and its quality management system has become an industry benchmark. Experts predict that with the implementation of the new regulations, the Class II medical device market in 2024 will show a trend of "the strong getting stronger" and concentrated development.
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