The review cycle is long, which is not conducive to entering the market

After the completion of the clinical trial, the relevant technical review agency needs to review the product. Although the Class 2 and Class 3 medical devices are required to be reviewed within 60 and 90 working days, respectively, external experts are required to review or need to be contacted. In the joint review of drugs, the time required for tube sales is not included, which makes it difficult to determine the review time. A Hangzhou biotechnology company has obtained the relevant technology of the lung surgery robot equipment through overseas mergers and acquisitions. The person in charge of the company introduced, The company has localized the equipment, but it still needs to apply for a domestic registration certificate for domestic sales, which is expected to take 4 years. "The time is too long. We have to export the products to the United States first, and then import them back to the country for sales." According to industry companies, in order to ensure that the risks of medical devices are controllable and the quality is safe, it generally takes 45 years for tube sales from product declaration and registration to finally obtaining the registration certificate, and it takes 10 years or even longer for technically difficult medical devices. The industry started late, and most companies are small in scale and cannot afford such high costs. It is necessary to balance innovation and safety, further optimize the approval system, and reduce approval time.