Zhejiang-made PET/CT is approved to be listed in the province's medical device industry to the forefront of the country

Both CT and PET are large-scale high-end medical imaging equipment, each of which costs between one million and ten million yuan. The cost of inspection using these equipment is also several hundred to tens of thousands. The combination of CT and PET is an organic and complementary combination of two different principles of equipment, through the image fusion processing system to form a single image for disease diagnosis and identification, lesion qualitative, surgery and radiotherapy positioning. Therefore, PET/CT is a technical high point in high-end medical imaging equipment.

Recently, the State Food and Drug Administration issued the People's Republic of China Medical Device Registration Certificate to the positron emission and X-ray computed tomography (PET/CT) device of Mingfeng Medical Systems Co., Ltd., and approved the product to be listed in China. This has a positive effect on the status quo of ending the import of similar products and reducing the related inspection costs.

Our province pays great attention to and supports the development of the medical device industry. On December 5, 2014, the “Opinions on “Precision Docking Accurate Service” Supported by the Office of the Provincial Government to Support the Development of the Medical Device Industry”. The State Food and Drug Administration and the Provincial Food and Drug Administration have implemented innovative green channel support for PET and PET/CT of Mingfeng Medical Systems Co., Ltd. In June and September 2015, both products were listed in accordance with the “Innovative Medical Devices”. Variety approved by the special approval procedure (trial).

In recent years, the research and development capabilities of Zhejiang medical device manufacturers have improved significantly. The provincial government has determined that 15 medical device companies such as Mingfeng Medical System Co., Ltd. have established provincial-level key enterprise research institutes. In 2014 and 2015, Hangzhou Qiming Medical Devices Co., Ltd. and Zhejiang Norcong Neuroelectronics Technology Co., Ltd. respectively won the China Innovation and Entrepreneurship Competition. The winner of the national finals in the biomedical industry. Six medical device products entered the national innovation product approval, namely: Hangzhou Qiming Medical Devices Co., Ltd. Percutaneous Interventional Artificial Heart Valve System, Mingfeng Medical System Co., Ltd. positron emission tomography (PET) and positron emission and X-ray computers Tomography imaging device (PET/CT is available), Hangzhou Guichuang Medical Devices Co., Ltd. drug-eluting PTA balloon dilatation catheter, Hangzhou Berry and Kang Gene Diagnostic Technology Co., Ltd. pre-implantation embryo chromosomal aneuploidy detection kit, Ningbo Shengjiekang Biotechnology Co., Ltd. intracavitary tumor cryoablation catheter, the number of innovative products ranked fifth in the country. The number of listed companies and the new third edition has increased significantly. Ningbo Meikang Biotechnology Co., Ltd. is listed, and Zhejiang Tiansong Medical Devices Co., Ltd. and other five companies are listed on the New Third Board. The quality management level of enterprises has been significantly improved, and 80% of the third type of medical devices have met the requirements for quality management of medical device production.

At present, the provincial departments have supported the development of the medical industry and have formed a good mechanism. The technical support for the development of medical devices such as technical review, inspection and certification, inspection and testing, and clinical data monitoring has been gradually improved; investment funds have been active in the medical device industry; innovative Enterprises are constantly emerging; innovative enterprises will promote the structural adjustment of the entire medical device industry through leap-forward development, and will promote the medical equipment industry in Zhejiang to the forefront of the country.