NORTH ANDOVER, Mass. – January 31, 2019 – ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped United Imaging to get NMPA (CFDA) innovation pathway approval within 12 months for its world’s first integrated CT-LINAC without a supplementary request. ChinaMed Device’s proven approach of integrating technical, clinical and regulatory knowledge and experience has overcome the challenges along the way and expedited time to market for United Imaging for NMPA innovation pathway approval.
The technology of integrating LINAC and CT to bring high-resolution image guidance during cancer treatment is a breakthrough in China. The NMPA regulatory registration and clinical trials certainly encountered challenges. However, ChinaMed Device’s team under the guidance of its clinical director, Jason Zhang, MD with the support of the China CEO, Tony Liu, who obtained NMPA first domestic premium PET/CT system approval, understood United Imaging’s CT-LINAC technology and the NMPA GCP process in China. The team completed the entire clinical trial process from protocol design to final reporting in less than 12 months for 70 patients with multiple types of cancers and clinical indications.
Radiotherapy is one of the key processes in cancer therapy. In China, over 70% cancer patients need radiotherapy at different disease stages. Compared to the traditional CT (key players include Philips, GE, Siemens) and linear accelerator (key players include Varian, Elekta, Siemens) in China market, United Imaging’s CT-LINAC is the world’s first integrated CT and linear accelerator which combines imaging diagnostic with radiotherapy together to achieve precise radiation.
United Imaging has overcome a major obstacle in radiotherapy: the precision of ionizing radiation given to patients. Because of the complexity of cancer, precision has become the core of the development of radiotherapy equipment in this decade. Often, while the radiation kills the cancer cells, it also damages the surrounding normal tissues. Equipped with diagnostic grade CT, CT-LINAC can display the details of organs and soft tissues in real time, and thus guide the precise implementation of radiotherapy. Moreover, it enables doctors to see the positional relationship between the lesion and the surrounding organs so that accidental injuries surrounding normal tissue can be avoided.
Another breakthrough is the relocation of lesions. Doctors need to track the location of the lesion in real time. In the course of radiotherapy, patients cannot make any position change at the site where they need treatment! Even a few micrometers’ changes may affect the overall radiotherapy effect. With several visual diagnostics spontaneously involved in the treatment of radiotherapy, CT-LINAC enables doctors to observe changes in the lesion.
Doctor Conghua Xie, Director of the Department of Tumor Radiotherapy and Chemotherapy at Zhongnan Hospital of Wuhan University, said “Changes in lesions can be seen before each radiotherapy treatment on the CT-LINAC. The physician can evaluate whether or not a correction plan is needed based on the images so that each stage of radiation therapy can be accurately implemented.” He also stated that “Now it’s like having a crystal ball in front of us that clearly tells us what will happen next and that’s exactly what both patients and doctors needed.”
With the help of ChinaMed Device, United Imaging’s CT-LINAC received the NMPA (CFDA) approval through an innovation pathway. What is more remarkable is that ChinaMed Device finished the complete clinical trial without having NMPA issuing any supplement requests or corrections!
As a Class III innovative active device with approval from NMPA innovation pathway, United Imaging’s CT-LINAC needed strong and robust clinical trial results in order to get the NMPA approval. ChinaMed Device, LLC conducted the entire clinical trial for United Imaging from clinical protocol design, site selection, patient recruitment, Adverse Events Reporting (AER), follow-up monitoring, Efficacy Evaluation Report (EER), Safety Evaluation Report (SER), and the final Clinical Report.
Highlights from this clinical trial:
ChinaMed Device, LLC accomplished the complete clinical trial process in fewer than 12 months from patient recruitments to final data reporting.
For regulatory or CRO services about NMPA (CFDA) innovation approval, please email info@ChinaMedDevice.com. For English version of innovation approval guideline, please also email us.
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory
strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.