Approval for Innovative Electron Linear Accelerator
Recently, NMPA approved the registration application of the innovative electronic linear accelerator produced by Linatech in Suzhou, China. This is the 124th innovative medical device approved by NMPA.
The product is composed of radiation head, rack, kV imaging system, MV imaging system, treatment table, main control cabinet, computer cabinet, control keyboard, console computer, isolation transformer, modulator and X-ray high voltage generator. It is used for three-dimensional conformal radiotherapy, intensity modulated radiotherapy, rotary radiotherapy and image-guided radiotherapy.
The product adopts orthogonal double-layer multi leaf collimation technology, which is the first in China. Its clinical advantage is to improve the dose fitness and dose uniformity of the target area. For the linear accelerator including single-layer multi leaf collimator, the product can better protect the organs at risk and better meet the clinical demand for accurate treatment of complex cases.
China encourages innovative medical device with lots of bonuses policy launched, which can help manufactures to expedite their registration in China market entry. IMD has seasoned staff in the registration of innovative medical devices. If you are interest in the innovative medical device in China, you can contact us (info@inspirativemed.com) to get a list of NMPA approved innovative medical devices for free.