Vietnam: Declaration of Pricing for medical devices (effective 1 April 2022)

ARQon
Jul 15, 2022
1 min read

“After a very active period of implementation, the Ministry of Health has built an electronic portal to declare and publicize prices for relevant organizations and individuals to implement. As of April 1, 2022, medical equipment must not be purchased and sold without the declared price and must not be purchased higher than the price declared on the Ministry of Health’s website at the time of purchase and sale” – Deputy Minister Do Xuan Tuyen added.

Deputy Minister Do Xuan Tuyen requested thuwcjc units and enterprises to strictly comply with Article 45 of Decree 98”, including: Declaration of prices of medical equipment; Publicize the price of medical equipment; The price of medical equipment is calculated in Vietnamese currency; The owner of the circulation number of medical equipment is responsible; The public prize on the Portal of the Ministry of Health includes all the information specified in Clause 2 of this Article. The table below shows the application fees and target review times in Vietnam for the different classes of medical devices.

	DMEC Fees	Standard Review Time	Review Time with Reference Country Approval
Class A	VND 1 million USD 43	Immediate	Immediate
Class B	VND 3 million USD 130	Immediate	Immediate
Class C	VND 5 million USD 216	60 days	10 days
Class D	VND 5 million USD 216	60 days	10 days
Advertising	VND 100,000 USD 5	5 days	--