In 2018, a total of 50 medical devices obtained the certification of innovative medical devices and entered the special review and approval process, and another 19 innovative medical devices got marketing approval. Additionally, 11 medical devices have been included in the priority review and approval process for medical devices, and another three have been marketed through the priority review and approval process.
This year, according to the review results of 15 batches of special review and approval applications for innovative medical devices published by Center for Medical Device Evaluation (CMDE), 50 applications were included in the special review process for innovative medical devices, which was 21.9% lower than that of 64 in 2017. In the meantime, 19 innovative medical devices were approved for marketing through this procedure, up 58.3% from 12 in 2017.
The Number of Innovative Medical Devices Included in Review and Approval Process and Approved for Marketing Over the Years
In terms of regional distribution, excluding nine imported products, 41 newly included domestic innovative medical devices in 2018 were mainly distributed in Beijing, Shanghai and Jiangsu province. While only two innovative medical devices of Guangdong province, which ranked No.3 in the total quantity, were included in the special review and approval process.
Regional Distribution of Products Included in the Special Review and Approval Process for Innovative Medical Devices
Since January 1, 2017, the priority review and approval process for medical devices has been officially implemented. By the end of 2018, a total of 20 products have been placed on the list, including 6 imported medical devices and 14 domestic medical devices. In 2018, a total of 8 batches of 11 products were included in the roll call of priority review and approval for medical devices, in which six imported medical devices were all on the list. By the end of 2018, a total of five medical devices (two in 2017 and three in 2018) have been ratified for marketing through the priority review and approval process.
Table: List of Product Which Have Been Ratified for Marketing through Priority Review and Approval Process for Medical Devices
This year, according to the review results of 15 batches of special review and approval applications for innovative medical devices published by Center for Medical Device Evaluation (CMDE), 50 applications were included in the special review process for innovative medical devices, which was 21.9% lower than that of 64 in 2017. In the meantime, 19 innovative medical devices were approved for marketing through this procedure, up 58.3% from 12 in 2017.
The Number of Innovative Medical Devices Included in Review and Approval Process and Approved for Marketing Over the Years
In terms of regional distribution, excluding nine imported products, 41 newly included domestic innovative medical devices in 2018 were mainly distributed in Beijing, Shanghai and Jiangsu province. While only two innovative medical devices of Guangdong province, which ranked No.3 in the total quantity, were included in the special review and approval process.
Regional Distribution of Products Included in the Special Review and Approval Process for Innovative Medical Devices
Since January 1, 2017, the priority review and approval process for medical devices has been officially implemented. By the end of 2018, a total of 20 products have been placed on the list, including 6 imported medical devices and 14 domestic medical devices. In 2018, a total of 8 batches of 11 products were included in the roll call of priority review and approval for medical devices, in which six imported medical devices were all on the list. By the end of 2018, a total of five medical devices (two in 2017 and three in 2018) have been ratified for marketing through the priority review and approval process.
Table: List of Product Which Have Been Ratified for Marketing through Priority Review and Approval Process for Medical Devices