On June 24, the Ministry of Health issued a decision on revoking the circulation registration number of equipment for the in vitro diagnostic medical equipment kit to detect SARS-CoV-2, type: LightPower iVASARS- CoV-2 1st RT-rPCR Kit of Technology Joint Stock Company Viet A.
At the decision signed by Deputy Minister in charge of administration of the Ministry of Health Do Xuan Tuyen, the Ministry of Health said that based on Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government stipulating functions and duties duties, powers and organizational structure of the Ministry of Health; Pursuant to Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical equipment; Pursuant to Notice No. 266-TB/UBKTTW dated April 13, 2022 of the Central Inspection Committee; and at the same time consider the proposal of the Director of the Department of Medical Equipment and Construction.
Test kit of Viet A Company
The Ministry of Health decided to revoke the free-sale registration number of medical equipment 2000001DKLH/BYT-TB-CT issued by the Ministry of Health under Decision No. 5071/QD-BYT dated December 4, 2020, specifically as follows:
Registration office: Viet A Technology Joint Stock Company, 372A/8 Ho Van Hue, Ward 09, Phu Nhuan District, Ho Chi Minh City; Production facility: Branch of Viet A Technology Joint Stock Company in Binh Duong, 1/9A National Highway 1A, Binh Duong 2 Quarter, An Binh Ward, Di An City, Binh Duong Province, Vietnam.
Owner of medical equipment: Viet A Technology Joint Stock Company, 372A/8 Ho Van Hue, Ward 09, Phu Nhuan District, HCMC.
Name of medical equipment: In vitro diagnostic medical equipment kit to detect RNA of Corona virus (SARS-CoV-2), type: LightPower iVASARS-CoV-2 1st RT-rPCR Kit.
The Ministry of Health stated that this decision annuls the contents related to Viet A Technology Joint Stock Company in Decision No. 5071/QD-BYT dated December 4, 2020 of the Minister of Health on the promulgation of the items of medical equipment granted circulation numbers in Vietnam.
Previously, the Ministry of Health had licensed the circulation of the test kit of Viet A Company. The Ministry of Health has affirmed that the licensed products have been evaluated to meet the requirements, meet the standards and quality of Vietnam and ensure compliance with current regulations.
The Ministry of Health has sent an official dispatch to introduce the Viet A kit product with the selling price of 470,000 VND/test so that the Departments of Health and hospitals can proactively contact and purchase for epidemic prevention and control.