Overseas Registration | Chinese Companies Account for 19.79% of 3,188 New U.S. Medical Device Registrations in 2022
According to MDCLOUD (Medical Device Data Cloud), the number of new medical device product registrations in the United States in 2022 reached 3,188, involving a total of 2,312 companies (medical device manufacturers) in 46 countries. Among them, 478 companies in China (including Hong Kong, Macau and Taiwan) have obtained 631 medical device product registrations in the U.S., accounting for 19.79% of the total number of new registrations of medical device products in the U.S., with a 4.1% year-on-year decrease in volume.
According to MDCLOUD (Medical Device Data Cloud), in 2022, among the newly registered medical device products in the United States, “implantable cardioverter-defibrillator (non-Crt)” has the highest number of newly registered products, with 275 pieces and five registered companies; the second ranked is “cardiac ablation percutaneous catheter”, with 221 pieces of newly registered products and five registered companies; the third ranked is “soft corneal contact lenses for prolonged wear”, with 216 pieces of newly registered products and five registered companies, respectively. The third is “soft corneal contact lenses for prolonged wear”, the number of newly registered products and registered enterprises are 216 and 5 respectively.
It is worth mentioning that among the top 20 product categories, only one product has a Chinese enterprise obtaining a product registration certificate in 2022, which is “polymer examination gloves”, and 62 of the 139 newly registered products are from Chinese enterprises, accounting for 44.6%.
In addition, from the point of view of the overall registration of Chinese enterprises, among the newly registered medical device products in the United States by Chinese enterprises in 2022, “polymer examination gloves” has the largest number of new registrations, 62 pieces, accounting for 44.6% of the total number of new registrations in this category, and there are 53 registered enterprises, accounting for 44.54% of the total number of new registrations in this category; followed by “medical-surgical masks”, 61 pieces of new registrations, accounting for 44.6% of the total number of new registrations. Second is “medical surgical masks”, the number of newly registered products is 61, registered enterprises have 60; ranked third is “electronic thermometer”, the number of newly registered products and registered enterprises are 25, 19.
Source of data: MDCLOUD
Post time: Jul-17-2023