What is the responsibility of owners in declaration of medical device prices in Vietnam?
I would like to ask, what is the responsibility of registration number holders in declaration of medical device prices in Vietnam? Looking forward to support under the new regulations.
According to Clause 4, Article 45 of Decree 98/2021/ND-CP (Effective from 01/01/2022) regulating the contents and responsibility for declaration of medical device prices in Vietnam, in which:
Registration number holders shall:
a) Make declaration of prices of their medical devices according to the declaration contents specified in Clause 1 of this Article and publish information on the Ministry of Health’s portal before such medical devices are placed on the market of Vietnam;
b) Update prices of medical devices whenever they are changed;
c) Request distributors to comply with the provisions of Points a and b of this Article in the case prescribed in Point c Clause 1 Article 25 of this Decree. In case of multiple distributors of the same medical device, one distributor shall be appointed to declare the medical device price. Other distributors shall not be required to make price declaration but shall not sell the medical device at a price higher than that declared by the appointed distributor;
d) Make declaration and explain elements constituting the medical device price to tax authorities or at the request of regulatory authorities.
Best Regards!
