In November 2022, a total of 1,578 new medical device products were registered and filed, down 66.43% year on year
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Registration and filing status of domestic and imported products
According to the statistics of MDCLOUD (Medical Device Data Cloud), in November 2022, the number of newly registered and filed medical device products in China totaled 1,578, a year-on-year decrease of 66.43% compared with November 2021.
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Registration and filing of product categories
In November 2022, among domestic products, the number of registered and filed products ranked first in the category of “in vitro diagnostic reagents”, with 458 pieces; The second and third places were “infusion, nursing and protective instruments” and “stomatological instruments”, with 308 and 96 registered and filed cases respectively. Among imported products, “passive surgical instruments” ranked first in the number of registered products category, accounting for 19 pieces; Ranking second and third respectively are “dental instruments” and “orthopedic surgical instruments”, with 13 and 11 registered and filed cases respectively.
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Registration and record of Class Ⅰ, Ⅱ and Ⅲ products
From the perspective of product type, the number of Class Ⅰ, Class Ⅱ and Class Ⅲ products registered and filed in November 2022 was 473, 1000 and 105, respectively, among which Class Ⅱ domestic products accounted for 98.4% and Class Ⅲ domestic products accounted for 85.71%.
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Registration and filing of products in various provinces
In terms of the number of newly added products registered and filed by provinces, Jiangsu ranked first with 230 cases. Guangdong Province and Shanghai ranked second and third with 195 and 177, respectively.
Among them, the number of class Ⅲ products registered in Guangdong province is the largest, the number of product registered and filed is 18, accounting for 20% of class Ⅲ products registered and filed proportion; The number of Class II products registered and filed in Jiangsu province was the largest, with 182 products registered and filed, accounting for 21.44% of Class II products registered and filed. The number of Class Ⅰ products registered in Shanghai was the largest, with 187 products registered and recorded, accounting for 33.41% of Class Ⅰ products registered and recorded.
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Information on product registration and filing of key enterprises
In November 2022, Chongqing Pumenchuang Biotechnology Co., Ltd. had the largest number of newly registered and filed products, with 28 products registered and filed. Shanghai Diagnology Co., LTD and Genentech (Shanghai) Co., LTD ranked second and third with 27 and 25 products registered and filed respectively.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Source: www.mdcloud.cn
Translated & edited by Bradyknows
