In January 2023, NMPA approved 124 medical devices, including 11 Class III imported products, 12 Class II imported products, and 99 Class III domestic products.
Below is a list of approved Class III and Class II imported products in January 2023.
The Center For Medical Device Evaluation of NMPA (NMPA CMDE for short) has made a summary of the work in 2022, the report is as follows:
Ⅰ. Registration application
It accepted 20,865 applications for registration of medical devices, including 5,389 filing changes, 2,035 imported Class I filing. A total of 13,066 applications were transferred to the technical review process, the transfer of the finalized project 14,486, 1,300 more than in 2021, an increase of 9.9 percent year-on-year.
II. Emergency Review Status
11 Nucleic acid test kit
10 Antibody test kit
47 Antigen detection kits
2 Medical device products
III. Review time
Application Type
Product Category
Average review time
Average time for expert consultation
Average time for applicant supplementary phase
Total time
Product Registration
Class II
72
0
245
317
Class III
99
1
178
278
Class II+Class III
95
1
187
283
Registration change of permitted matters
Class II
45
0
81
126
Class III
69
0
60
129
Class II+Class III
64
0
64
128
Renewal Registration
Class II
24
0
13
37
Class III
46
0
28
74
Class II+Class III
39
0
24
62
IV. Collective decision-making
29 meetings of CMDE technical meetings
679 meetings of CMDE branch technical meetings
Ⅴ. Deficiency letter, expert panel meeting and audit
Supplementary Information for deficiency letter Issued 5,698 deficiency letters Received 5,626 items of supplementary dossiers
The Ministry Of Finance of China Reduces Tariffs On Imported Medical Devices
To protect human health and reduce patients’ economic burden, the Ministry of Finance of the People’s Republic of China issued the tariff adjustment plan on December 29, and will reduce import tariffs for 13 types of medical devices from January 1, 2023; and 37 types of medical device products will achieve zero import tariffs.
Policy Highlights
Further reduction of import tariffs for some medical devices
China will implement provisional import tax rates lower than the most-favored-nation (MFN) tariff rate for 1020 items. Among them, 13 types of medical devices such as spring rings, dentures, raw materials for vascular stents and contrast agents will achieve further reduction in import tariffs starting Jan 1, 2023.
Zero import tariff for some medical devices
The eighth step of tariff reduction will be implemented for the MFN tariff rate of the products listed in the Amendment to the Tariff Concession Schedule of the World Trade Organization Accession Protocol of the People’s Republic of China for the expansion of the information technology agreement. After the implementation of the policy, 37 types of medical device products will achieve zero tariff on imports starting July 1, 2023.
New tax item for surgical robots
In the adjustment of import and export tariffs, it is clear that surgical robot tax items will be increased in 2023 to meet the needs of industrial development and scientific and technological progress. Surgical robot refers to a medical device consisting of a robotic arm, console, imaging system and other components that can perform complex surgical operations in a minimally invasive manner. Including orthopedic surgery robot, neurosurgery robot, radiation interventional surgery robots.
NMPA Facilitates the Usage of Medical Device Master Files
The NMPA issued a notice on further clarifying matters related to the registration and use of the master files of medical devices on January 18, 2023.
Combined with the registration and use of medical device master files, the following matters are clarified:
Medical device master file is a form of technical data, such data is submitted directly by its owner to the medical device regulator, used to authorize the applicant for registration of medical device products in the declaration of medical device registration and other matters. The registration of medical device master file is a voluntary act.
Medical device master file registration is mainly related to medical device raw materials. Medical device master file system applies to the medical device registration applicant in China’s imports of Class II, Class III and domestic Class III medical devices (including in vitro diagnostic reagents) registration, changes, clinical trial approval and other applications referenced in the registration of the master file. According to the actual situation, local NMPA can carry out the main file registration items of domestic Class II medical devices by referring to this announcement.
The new website was built based on the newly updated clinical evaluation requirements and regulation in China under the Order 739.
We are here to help you obtain China market approval for your medical devices with a comprehensive Clinical Evaluation Report (CER). Before jumping to any conclusions, use our newly developed tool for a
