On December 20, 2024, the Vietnam Ministry of Health (MoH) issued a draft amendment and supplement to several articles of Decree No. 98/2021/ND-CP, dated November 8, 2021, on Medical Devices Management. This draft follows previous amendments introduced by Decree No. 07/2023/ND-CP, dated March 3, 2023.
The draft aims to enhance regulatory processes while addressing key issues in medical device management. Below are the key proposed changes:
Extension of Import Licenses
- Import licenses for medical devices issued between January 1, 2018, and December 31, 2021, will be extended by six months, making them valid until June 30, 2025.
- There will be no restrictions on the number of imports during this extended validity period.
Importation of Class C and D Medical Devices
- Class C and D medical devices that do not require an import license may be imported based on classification results published on the MoH’s portal.
- Exclusions: Chemicals, insecticides, and disinfectants used for household and medical device disinfection.
- Customs Clearance Flexibility:
- No quantity limits.
- No need to submit documents confirming they are medical devices from the MoH.
- Valid regardless of the announcement timing on the MoH’s electronic portal.
- These provisions are valid until June 30, 2025.
Validity of Circulation Registration Numbers
- Circulation registration numbers for in vitro diagnostic biological products issued between January 1, 2014, and December 31, 2019, will remain valid until June 30, 2025.
Import Licenses Under Clause 4, Article 76
- Import licenses issued under the provisions of Clause 4, Article 76 of Decree No. 98/2021/ND-CP will remain valid until June 30, 2025.
Additional Information
For further details, please refer to the draft regulation: Decree amendments and supplements to the Decree on Medical Devices Management.pdf (in Vietnamese)
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