On January 1, 2025, the Ministry of Health (MoH) of Vietnam announced the issuance of 04/2025/ND/CP, which includes amendments and supplements to 98/2021/ND-CP regarding medical device management, as well as updates to 07/2023/ND-CP.
The updated content is as follows:
1. Extended Validity of Import Licenses.
a) Import permits for medical equipment issued between January 1, 2018, and December 31, 2021, will remain valid until June 30, 2025.
b) There are no restrictions on the import quantity within the extended period of the import license
c) Organizations holding the import licenses specified in a) and b) must ensure that all legal conditions are met and that the quality, quantity, type and Intended purpose of imported medical device are guaranteed. The MoH will be responsible for revoking the licenses if these conditions are violated.
2. Medical Devices Exempt from Import Licenses.
- Medical devices are not required an import license (excluding household and medical chemicals, insecticides, and disinfectants), as well as medical equipment classified as Class C and D, will have their import license validity extended until June 30, 2025, and can be imported without MoH documentation. Additionally, these medical devices, once certified, will not rely on the MoH’s electronic information portal for customs clearance procedures, and the information will not be dependent on when it is published.
3. Extension of Circulation Registration Numbers
- Circulation registration numbers for in-vitro diagnostic products issued between January 1, 2014, and December 31, 2019, will remain valid until June 30, 2025.
This regulation came into effect on January 1, 2025.
Please refer to the attached document below.
If you have any questions about medical device,
please contact us with the below.
ra@jnmglobal.net
info@jnmglobal.net