FROM 2022, ONLY MEDICAL EQUIPMENT WHOSE PRICES HAVE BEEN DECLARED ARE ALLOWED TO PURCHASE
This highlight content is prescribed by the Government in the Decree No. 98/2021/ND-CP dated November 08, 2021, on the management of medical devices.
In accordance with the new provisions, to exempt from declaration of applicable standards and circulation registration for medical device is imported into Vietnam to serve the purposes of emergency aid or provision of humanitarian medical services; unregistered medical devices which are imported to serve pandemic prevention and control, or catastrophe and disaster relief and cannot be replaced by any other medical devices sold on the market.
Noticeably, it is required to post up the wholesale and retail prices of medical devices in VND at transaction or selling locations of medical device trading establishments; such prices shall be publicly posted on a board, paper or in other forms. Especially, it is not allowed to trade medical devices before the prices are declared or at prices higher than those available on the Ministry of Health’s portal on management of medical devices at the time of trading.
The Government also announces 11 online procedures related to medical equipment, including: Declaration of eligibility for manufacture of medical devices; Declaration of applicable standards for medical devices; Application for registration of medical devices; Declaration of prices of medical devices; Application for the License to import medical devices, etc.
This Decree takes effect from January 01, 2022.
