On March 3, 2023, the government of Vietnam issued Decree No. 07/2023/ND-CP (Decree 07) amending Decree 98/2021/ND-CP on medical device management (Decree 98) to resolve many urgent problems in the healthcare sector in Vietnam. Decree 07 took effect on the same day and amends and supplements several articles in its predecessor, Decree 98, which originally took effect on January 1, 2022. Some outstanding points of Decree 07 are summarized below.
1. Registration of Medical Devices
The compulsory implementation of the ASEAN Common Submission Dossier Template (CSDT) in registration applications for medical devices will be delayed until January 1, 2024, instead of the deadline of January 1, 2023 under Decree 98.
In addition, if after three rounds of amendment/supplementation as requested by the authority, the registration dossiers still have not been approved, the applicants must submit new registration dossiers.
2. Withdrawal of Registration Number
Decree 98 adds one case for withdrawing the registration number of a medical device, which is when the documents in the registration dossier are concluded by the authority to be noncompliant with the provisions of law.
3. Listing Price of Medical Devices
It is required for establishments manufacturing or trading medical devices to list their prices in locations stipulated under Article 17 of Decree No. 177/2013/ND-CP implementing the Law on Prices (such as at transaction or selling locations of the trading establishments) or on the online portal of the Department of Medical Equipment and Construction’s (DMEC).
4. Price Declaration
It is no longer required to declare prices of all medical devices circulating on the Vietnam market. Instead, the Ministry of Health will issue and adjust the list of medical devices subject to price declaration, depending on management requirements and the actual situation, especially when there are abnormal fluctuations in prices affecting the supply of medical devices, buyers’ ability to pay, and the solvency of the Health Insurance Fund.
5. Importing Used Medical Devices
Decree 07 removes used medical devices from the list of medical devices subject to import licenses. The importation of used medical devices will be under the regulations on foreign trade management.
6. Transitional Regulations
Validity of Import Licenses:
- Import licenses for medical devices that were granted from January 1, 2018, to December 31, 2021, will be valid until December 31, 2024.
- Import licenses for medical devices that are no longer subject to import licenses, and whose classification results of Class C or D were published on the Portal of Medical Device Management, can continue to be imported until December 31, 2024, with no limit on import quantity.
Validity of Registration Numbers or Marketing Authorizations:
- Marketing authorizations granted to domestic medical devices before January 1, 2022, will be valid until their expiry date.
- Registration numbers for medical devices that are IVD biologicals that were granted from January 1, 2014, to December 31, 2019, will be valid until December 31, 2024.
- Registration numbers for medical devices that are IVD biologicals that were granted from January 1, 2020, to December 31, 2021, will be valid until their expiry date.
The regulation of “prohibition of buying or selling medical devices without the declared price and buying or selling at higher prices compared to the public price on the Portal of the Ministry of Health at the time of purchase” is not mandatory for bidding packages opened before April 1, 2022.
For further information, please contact:
Hien Thi Thu Vu, Tilleke & Gibbins
thuhien.v@tilleke.com
