The NMPA released the Annual Report for Medical Device Registration on February 5, 2021. In 2020, the NMPA accepted a total of 10,579 medical device initial registrations, registration renewals and registration changes, in which imported devices account for 61.1% of the total number.
Despite the impact of the pandemic, the total number of acceptance increased by 15.6% compared with 2019.
Applications of imported Class II devices
The NMPA accepted a total of 3,311 imported Class II medical device registrations which increased by 8.5% compared with 2019. There were 1,738 applications for medical devices and 1,573 IVDs.
Applications of imported Class III devices
They accepted a total of 3,048 imported Class III medical device registrations, increased by 20% compared with 2019. There were 2,571 applications for medical devices and 477 IVDs.
In 2020, NMPA approved a total of 9,849 medical device initial registrations, registration renewals and registration of changes, increased by 16.3% compared with 2019. 214 registration applications were voluntarily withdrawn by the companies.
The NMPA approvals in the past seven years are shown below.
Approvals of domestic Class III medical devices
NMPA approved 3,603 domestic Class III medical devices. There were 2,306 medical devices and 1,297 IVDs.The approvals of imported Class II medical devices
NMPA approved a total of 3,437 imported Class II medical device registrations. Among them, there were 1,639 applications for medical device registration and 1,798 applications for in IVD registration.
Approvals of imported Class III medical devices
NMPA approved 2,809 imported Class III medical device registrations. there were 2,351 medical devices and 458 IVDs.
Ranking of top five devices
The registered imported medical devices involve 10 sub-categories of the Medical Device Classification Catalog. The top imported Class III medical devices are: dental equipment, medical imaging equipment, passive implantation equipment, neurological and cardiovascular surgery equipment, and ophthalmic equipment. Among them, dental equipment increased from 57 in 2019 to 66 in 2020, a jump of about 15.8%.
Home countries of imported medical devices
In 2020, the United States, Germany, Japan, South Korea, and Switzerland ranked the top five for the initial registration of imported medical device in China. The number of registered products accounts for about 72.3% of the total number of initial registrations of imported products in 2020,.