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The long review period is not conducive to entering the market
2020-09-30 20:22:04 Technical News 25 Views
After the completion of clinical trials, the relevant technical review institutions need to review the product. Although Class II and Class III medical devices are respectively stipulated to be reviewed within 60 and 90 working days, the time required for the sale of tubes is not included in the review by external experts or in joint review with drugs, making it difficult to determine the review time. A biotechnology company in Hangzhou has obtained the relevant technology of lung surgery robot equipment through overseas mergers and acquisitions. The person in charge of the enterprise introduced that the company has already localized the equipment, but it still needs to apply for a domestic registration certificate for domestic sales, which is expected to take four years. "It takes too long. Our tube sales team has no choice but to export the products to the United States first and then import them back to China for sale." Industry enterprises introduce that to ensure the controllable risks and quality safety of medical devices, the sales of tubes usually take four to five years from product application and registration to finally obtaining the registration certificate. For those with high technical difficulty, it may take ten years or even longer. Due to the late start of China's medical device industry and the small scale of most enterprises, it is difficult for them to bear such high costs. It is necessary to strike a balance between innovation and safety, further optimize the approval system and reduce the approval time.
