Meilun: Precision Medical Technology Breakthrough: Accelerated Clinical Medical Transformation

According to the Xinhua News Agency reported that experts recently in the Ministry of Science and Technology and other departments jointly organized by the advanced scientific and technological achievements show that China should be based on their own disease spectrum, the development of "Chinese version" precision medical diseases. China as a major tumor, is currently facing a lower incidence of cancer and improve cancer survival rate of the dual challenges, the demand for precision medical care is imminent.

Expert introduction, precision medical treatment is based on clinical information, the application of modern genetic technology, molecular imaging technology, bio-information technology, combined with the patient's living environment to implement accurate classification and diagnosis of disease treatment, to develop a personalized disease prevention and treatment programs. Institutions that the past two years of precision medical technology breakthroughs and clinical transformation were significantly accelerated, China's strong support for sequencing equipment and reagents of the localization, nipt pilot release reflects the modality of the regulatory support after the attitude. Precision medical care from the concept has set off a new round of medical revolution, in the "technology + capital + policy" will be applied to the individual life cycle of health management and decision-making, in a high economic cycle.

Release from the clinical trial medical device directory, help to reduce the workload of the enterprise registration report. In 2016, the Directorate issued the second batch of clinical trial medical device directory, 359 kinds of medical device products from clinical trials. In May this year, the General Administration of the third batch from the clinical trial medical device catalog for comments. April 6 this year, the General Administration has also issued "on the adjustment of some medical equipment administrative examination and approval of the approval process," the third category of high-risk medical equipment clinical trial approval decision, the third category of medical equipment and imported medical equipment licensing matters Change the approval decision, the third category of domestic medical equipment and imported medical equipment to continue the registration approval decision, adjusted for the General Administration of Medical Devices Technology Review Center (hereinafter referred to as "the General Administration of the Center") to complete.

To promote the classification management reform

Classification management is an important basis for the examination and approval of medical devices. In 2016, the General Administration of the existing 6 million medical device registered products to sort out the analysis, the formation of "medical device classification directory (draft)." The newly revised catalog catalog framework is more reasonable, the richer architecture, product coverage is more comprehensive, scientific and guiding significantly improved. In March this year, the General Office announced the first medical device classification technical committee members of the professional group list, which is the medical device supervision process in a landmark event. The classification technical committee as the General Administration of medical equipment classification management of the important technical support, with 16 professional groups, the appointment of 288 members. In April this year, the General Administration issued the "State Food and Drug Administration Medical Device Classification Technical Committee Working Rules" to further strengthen and standardize the classification of technical committee work management. Reporters learned that the General Administration of the classification of the technical committee of the professional group of new revised "medical device classification directory" to review and improve, as soon as possible according to the program.