Vietnam: Vietnam Government released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management
On 03 Mar 2023, the Vietnam Government signed and released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management, which takes effect immediately. Some of the key highlights are mentioned below:
Management of medical device prices
Listing of prices of medical devices
- Organizations and individuals manufacturing and trading in medical devices shall post up prices of medical devices at the trading locations prescribed by law on prices which regulated in Article 17, Decree 177/2013/NĐ-CP on 14 Mar 2013 about detailing and guiding the implementation of a number of the law on price) or on the website of the Ministry of Health.
- In case the price of medical devices is listed on the website of the Ministry of Health, the following minimum information is required:
a) Name and model of medical devices.
b) Manufacturing site and Legal manufacturer
c) Unit of calculation.
d) Configuration, technical features of medical devices
e) Listed price of medical devices.
Declaring the price of medical devices
- Production, business organizations, and individuals must declare prices, declaration contents, orders, and procedures for declaring prices of medical devices in accordance with the law on prices.
- The Ministry of Health shall issue, update, amend, and supplement the list and guide information on medical devices subject to price declaration based on the actual situation such as an abnormal fluctuation in price affecting the supply of medical devices, the ability of the buyer to pay, and the solvency of the Health Insurance Fund.
- Organizations and individuals manufacturing and trading in medical devices shall declare prices of medical devices in the forms prescribed by law on prices or on the website of the Ministry of Health. Accordingly, the Ministry of Health will issue the guideline on the information of medical devices subject to price declaration in the next time.
Registration of the circulation of medical devices
- The validity of the import licenses will be extended until December 31, 2024.
- There is no expiration date for the circulation licenses which were granted according to Decree 36/2016/ND-CP before 01 Jan 2022.
- For medical devices class C and D that are not on the list of required import licenses (except for chemicals, insecticidal, and germicidal preparations used in the household and medical fields that have only one purpose of disinfecting the medical devices), a classification letter can be used for importation until the end of December 31, 2024.
- With the applications for the import license submitted before 01 Jan 2022, but not yet granted the import license, the Ministry of Health has the responsibility to inform and guide the company to submit and complete the product license application according to Decree 98/2021/ND-CP and have the priority to be evaluated soon.
The dossiers of applications for an import license submitted before January 1, 2022, will continue to be processed if the company has demanded granting of the import license. The issued license will be valid until the end of December 31, 2024.
- The number of amendments and supplements to the application for registration of circulation decreased from 05 times to 03 times. This is to enforce companies to strictly comply with the regulations and requirements of the MoH.
- The Common Submission Dossier Template (CSDT) must be implemented starting January 1, 2024.
For more in-depth information, read the full Decree here.
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