Report on the Registration of Medicare Products in the First Quarter of 2022
2022-05-16
Product type:
2978 new category ⅱ products were registered
From the type of products, there were 4195 new type I product filing in the first quarter of 2022, of which 4105 were domestic products; The number of registration of new class II and III products were 2978 and 471, respectively, and the number of domestic products were 2914 and 395, respectively.
Product macrocategories:
In vitro diagnostic reagents accounted for three per cent
In terms of product macrocategories, the largest number of new registrations and filing was for in vitro diagnostic reagents, 2308, of which 2263 were domestic produced; The second is the infusion, nursing and protective instruments, and the number of product registration and filing was 1572, of which 1559 were domestic products; The number of newly registered and filed products of TCM instruments were 186, all of which were domestic products; The number of new registration and filing of radiotherapy devices are14, of which there were 9 domestic products, and the domestic percentage was relatively low, at 64.29%.
Key Products
I-2 Products for sample processing added 130 pieces
In the first quarter of 2022, a total of 156 new products were registered and filed, breaking through the zero registration of domestic and imported products in 2021, of which, the number of new registrations for Ⅰ-2 sample processing products was the largest, 130, with 120 domestic products, accounting for 92.31% of domestic products; the number of new filings for scanning image analysis systems was 13, with 9 domestic products, accounting for a relatively the number of new filings for scanning image analysis systems was 13, with 9 domestic products and a relatively low domestic share of 69.23%.
Source: Medical Device Data Inspection
Author： JOINCHAIN
Edited and translated by bradyknows
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