Foreign pharmaceutical firms will enjoy a fresh start in their medical equipment business as various shortcomings related to marketing authorisation were ironed out.
The business community is supporting the issuance of Decree No.07/2023/ND-CP on March 3, amending and supplementing a number of articles on medical equipment management, with marketing authorisations (MAs) being among top-reached expectations among multinational corporations.
|Medical equipment fortunes increase via rule untangling, Illustrative image (Photo: VNA) |
Deputy Minister of Health Le Duc Luan said, “The Ministry of Health (MoH) has worked with ministries and agencies on the amendment to help solve problems. When the document takes effect, units can bid for the procurement of supplies, medical equipment, and chemicals to ensure treatment needs.”
“Problems that are related to prices will be a focus. In the past, it was required to have three quotations, but there are exclusive items that do not have enough for three quotes, so we suggest the amendment moves towards accepting certain cases having only one or two quotes to choose from.”
Coming into effect from the signing date, the new decree allows automatic renewal of import licence, and circulation registration number for medical devices.
It regulates that import licence of such devices issued from January 1, 2018 to December 31, 2021 will continue to be used until the end of 2024; the circulation registration number for medical devices for in-vitro diagnostic bioproducts also continues to be used until the end of 2024; and more besides.
The new rules are expected to put an end to the shortfall of related devices due to the expiry of the Class C and D import licence and delays in the issuance of MAs, which caused negative impacts on both treatment activities and business activities. Meanwhile, the progress of issuing new circulation numbers for medical devices is slow and failing to meet demand.
MAs have been considered a critical issue, including for members of the Medical Devices and Diagnostics Sector Committee under the European Chamber of Commerce in Vietnam. At the Whitebook launch on February 16, committee chairman Qadeer Raza said, “Since the start of 2022, of the total number of MA dossiers for Class C and D medical devices that enterprises have submitted under Decree No.98/2021/ND-CP, only about 12 per cent of submitted products have been approved. This has created an acute shortage of critical life-saving devices affecting the timely diagnosis and treatment of patients with various disease conditions.”
The committee now represents 27 members from the international devices and in-vitro diagnostics industry, including Abbott Laboratories, B.Braun, GE Vietnam, Medtronic, Roche, and Philips.
Decree 07 is also expected to bring fresh air to multinationals in Vietnam, where healthcare demand is growing. At present, about 90 per cent of medical equipment and supplies are imported into the country.
Besides the automation renewal of import licences and MAs, other highlights of the new decree include the gradual transition from pre-inspections to post-inspections for medical devices, change in management, declaration of prices of related devices, and amending regulations on import and export and temporary import and re-export of medical equipment.
In particular, the decree stipulates the implementation of price listing for all related devices at locations specified by the rules on prices or on the portal of the MoH. Current regulations require the declaration of priced of related devices for more than 200,000 types, and each type has many different configurations and technical features, thus causing overload in the health sector.
The decree is designed so that the import of used medical devices complies with the provisions on foreign trade management, and the MoH does not issue a licence to import used them.
In addition, the government has considered a resolution to pilot policy mechanisms to ensure purchase of medicines, related devices, and exam and treatment costs are carried in accordance with the specific conditions of the health sector until relevant legal documents are issued.
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