The shortest is only 29 days! Medical device innovation approval and priority approval of large inventory

The Special Review Procedure for Innovative Medical Devices ("Innovation Approval") has been in place for five and a half years from the pilot version of 2014 to the revised version of 2018, and the Medical Device Priority Approval Procedure ("Priority Approval") was implemented on January 1, 2017, nearly four years after its implementation.
The two major procedures are the "green channel" of medical device approval opened by the State Drug Administration based on encouraging medical device research and development innovation and meeting the demands of clinical urgent needs, which greatly shortens the time-to-market of products by priority arrangements for review, speeding up the efficiency of review and approval, and ensuring that the corresponding products and results can be applied to clinical practice as soon as possible.
1. As of September 30, 2020, the Equipment Review Center (CMDE) of the State Drug Administration has announced that 279 products have entered the innovation approval, of which 89 products have been approved for listing through the channel, and 44 products have been approved for priority, 21 of which have been approved for listing through the channel.
data source: Firestone creation from CMDE market speed significantly accelerated, approval time is expected to be further shortened.
according to the normal process, the approval of class II medical devices will take about 2 years, and the approval of class 3 medical devices will take about 3 years.
And according to statistics, products that have been approved for listing through innovation take an average of 682.5 days from publicity to approval, less than 2 years, the fastest time is only 29 days;
the future, approval times are expected to be further reduced as experience accumulates and processes are optimized.
Data Source: Firestone Creation Finishing Since CMDE II, Special Approval for Innovative Medical Devices since its implementation on March 1, 2014, the number of products for annual publicity and approval of innovative approvals has increased year by year, peaking in the period before and after 2017, and beginning to show a downward trend after the 2018 revision.
data sources: Firestone creation and finishing from CMDE the above-mentioned status quo may be due to: 1. review procedures of the content and process adjustment, leading to the application of the situation, approval standards more stringent norms;
shows that domestic medical device product innovation momentum is insufficient, enterprise innovation investment still needs to be further strengthened.
high-value consumables occupy half of the mountain.
In terms of sub-areas, high-value consumables such as cardiovascular, orthopaedic, ophthalmology and dentistry accounted for the largest proportion, close to 50%, especially in the field of vascular stents, where imported alternatives were essentially realized, and many drug-washed stents, cladding stents and absorbable stents entered for innovative approval;
data source: Firestone creation and finishing from CMDE four cluster areas accounted for nearly 90%.
From the geographical distribution point of view, in addition to 35 imported products, the Yangtze River Delta, the Pearl River Delta, Beijing-Tianjin-Hebei and Sichuan-Yuzhou four major industrial clusters into the innovation and approval of the number of domestic products accounted for nearly 90% of the country.
data sources: Firestone created from CMDE, Beijing (56), Guangdong (47), Shanghai (46), Jiangsu (36), Zhejiang (17) firmly occupy the number of publicity and approval of the top five.
data source: Firestone creates a number of products compiled from CMDE micro-invasional medical and pioneering technology leading.
From the number of individual enterprises included in the innovation approval, micro-invasive medical by virtue of the strong performance of its business line subsidiaries, become the largest number of products included in the innovation approval and approved for listing, including minimally invasive heart, minimally invasive electrophysiology, minimally invasive Shentong, minimally invasive medical robots have a number of products into innovation approval, and 7 products have been listed through the channel;
In addition, Beijing Pinchi, Suzhou Jingxuan, Haijiea and other enterprises have products to system product declaration innovation, and the need for kits or accessories to work with each other, so in the form of multiple accessories or kits at the same time approved.
3, medical device priority approval since January 1, 2017, priority approval to publicize 44 medical device products, 21 of which were approved through the channel for listing, accounting for nearly 50%.
domestic production accounted for 70%.
of the products approved and approved, 30 were domestic products, accounting for 68.2%, and 14 were imported products, accounting for 31.8% of all publicized products.
, unlike the selection criteria for innovation approval, priority approvals emphasize clinical needs more, and therefore have a relatively weak incentive for domestic innovation, which may be part of the reason for the preference approval of more imported products.
"included in the national key research and development plan" as the main reason for selection.
Priority approval is mainly to speed up the "diagnosis or treatment of rare diseases, malignant tumors, elderly-specific and multiple diseases, dedicated to children, clinical urgent needs and other medical devices, as well as included in the national science and technology major special or national key research and development plan" medical device review and approval, from the public product selection reasons, "included in the national key research and development plan" has become the most important reason for selection, followed by "clinical urgent need" and "included in the national science and technology major special project."
data source: Firestone created from CMDE innovation approval and priority approval of the two green channels significantly shortened the innovation and clinical urgent needs of medical device products to market time, not only to solve the clinical needs of a great help, but also greatly stimulated China's medical device enterprises research and development innovation enthusiasm.
note: This document data are created by Firestone from CMDE, according to the registration certificate number count (including multiple suites used with the system class products, each kit corresponding to a registration certificate, so a product may correspond to 2-3 registration certificates), statistics as of 2020 Q3.
author of the book, Scho