The State Food and Drug Administration approved the registration of the listing of 107 medical device products
On May 16th, May 15th, the State Drug Administration issued a message, announcing the 107 medical devices approved for listing in April this year. Among them, there are 52 medical device products of the third type in the territory, and imports of the third type of medical equipment. There are 23 device products, 32 imported the second type of medical device products.
From January to March this year, the State Food and Drug Administration approved the listing medical instruments The number of products was 88, 96, and 94, plus 107 approved in April, and 385 were approved in the first four months. In January-April 2017, 135 and 39 were approved respectively. 130, 90, a total of 394. Compared to two years, the number of approvals in the first four months after the opening year is basically the same.
Attachment: Approved Registration of Medical Devices Catalogue in April 2018
No.
product name
Registrant name
Registration number
The third type of medical device in the territory
1
Human MTHFR (C677T) Gene
Polymorphism Detection Kit
(PCR-melting curve method)
Wuxi Ruiqi Gene Biotechnology Co., Ltd.
China National Medicine Administration Corporation, Inc. 20183400118
2
ABO Prototype and Rh (D/C/E) Blood Test Card (Microcolumn Gel)
Shenzhen Yunuo Biotechnology Co., Ltd.
China National Medicine Agency, Inc. 20183400119
3
Human CYP2C19 Genotyping Test Kit (PCR-melting curve method)
