Document Number: No. 1 of 2024
On January 22, 2024, the China CMDE announced that seven innovative medical devices, including the cardiac pulse electric field ablation system of Insight Lifetech Co., Ltd., and the interventional ventricular assist system of Xinqing Medical (Suzhou) Co., Ltd., have entered the special review process.
Special Instruction: Entry into the innovation review procedure does not imply that the product has been determined to be safe and effective for registration. The applicant still needs to conduct R&D and apply for registration in accordance with the relevant requirements.