How many kinds of SARS-CoV-2 test kits and suppliers have the Ministry of Health (MoH) granted marketing authorisations?

Nguyen Minh Loi, director of the Ministry of Health’s Department of Medical Equipment and Construction

As of February 23, the MoH has licensed 169 medical devices and in-vitro diagnostic biology products for testing SARS-CoV-2, including 14 being domestically made and 155 imported.

These products have to get authorisation or import licences in line with prevailing rules when they are available in the market. Trading units of these products also have to meet requirements for trading them aligned with Decree No.98/2021/ND-CP from last November on governing state management of medical equipment.

Recent days have seen sudden strong demand for self-testing, resulting in uncontrolled prices. What solutions are the ministry taking to deal with the situation?

The MoH is aware of the fact that there is a partial scarcity of rapid test kits and fluctuation of prices as COVID-19 continues to develop. Through various information channels, we have found that some are taking advantage of the pandemic to unreasonably increase the prices of medical devices.

To have timely solutions, the MoH on February 23 held an online meeting with manufacturers and importers of test kits to announce the deployment of some measures.

The MoH urges producers and importers of these test kits to increase production capacity and import volume to ensure supply and quality; to make public any updates on prices; for distributors and retailers to provide price listings; and for them not to sell to speculators to make quick profits, causing a scarcity in the market.

We have announced updated guidelines for COVID-19 infections, and for those closely contacted. Therefore, people should carefully take into account the purchase of such a test kit, and contact healthcare facilities for further guidance, thus preventing rampant use which can affect the market.

When necessary, people should buy test kits with clear origins which are named in the list of products licensed by the ministry to avoid fake and low quality products.

In addition, the MoH has sent documents to municipal and provincial authorities, urging their collaboration in directing local units to ensure production capacity, and trading activities of medical devices to ensure the supply and stabilisation of prices; while directing authorised agencies and market management units to strengthen inspection over the listing of prices so as to prevent profiteering activities.

Finally, to further stabilise the price of test kits in the market, the MoH will work with price management agencies and market management units, customs offices, and other relevant units to do regulation checks and inspections over price listing and announcement of selling prices in line with prevailing rules to ensure reasonable selling prices, and prevent any unreasonable increases.

COVID-19 test kits and medication are conditional business items so they have to get licenses from authorised health agencies. However, the trading of such products is still in chaos. What are the ministry’s next steps to stabilise the market?

The ministry is focusing on several measures in regards to this. It is working with the Ministry of Finance and other relevant ministries and agencies to propose the government add test kits to a list of price stabilisation products.

Tender results will be made public and their prices will be declared. Moreover, products receiving market authorisation and import licenses, as well as those revoked, will also be announced.

The ministry is accelerating the application of IT and fast-tracking granting of licenses as regulated so as to meet demand.

Collaboration between health inspectors and price management agencies, market management agencies, customs agencies, and relevant units at all levels will also be further strengthened to help inspect and strictly punish violators to ensure market stabilisation.