Medical equipment classification to improve bidding efficiency

The report of the Department of Infrastructure and Medical Equipment ( Ministry of Health ) shows that, in the past time, the unit has organized many surprise inspections to promptly detect and handle violations in the field of medical equipment. At the district level, many hospitals have encountered difficulties in bidding for medical equipment due to lack of specialized human resources, difficulty in accessing information on prices, quality and suppliers. Some businesses also reported that the procedures for exporting medical equipment are still complicated, and the progress of processing records for circulating equipment of types C and D is still slow. In particular, many domestic products are of high quality, with CE, FDA, ISO certifications, but have not been prioritized in bidding due to the lack of a suitable classification system.

According to Mr. Nguyen Minh Loi, Director of the Department of Infrastructure and Medical Equipment (Ministry of Health), the Ministry of Health is giving special priority to domestically produced medical equipment products, in order to be consistent with the national healthcare development orientation, reduce dependence on imports and proactively increase equipment supply.

To overcome the above shortcomings, the draft stipulates that medical devices will be grouped based on two main criteria, including technical standards and quality. With technical standards, devices must have a document confirming compliance with standards issued by a reputable assessment organization, recognized by international organizations such as ILAC, IAF or MDSAP. This is to ensure that devices put into use at medical facilities fully meet technical requirements, in accordance with medical examination and treatment practices in Vietnam.

Regarding quality, medical devices must have been licensed for circulation by reputable domestic and foreign management agencies, including the Vietnamese Ministry of Health, FDA (USA), TGA (Australia), Health Canada, MHLW/PMDA (Japan), EU countries, UK, Switzerland, NMPA (China) and MFDS (Korea).

According to experts, using international circulation standards as a basis for evaluation will help medical facilities choose safe medical equipment, while encouraging suppliers to improve product quality, creating a fair playing field between imported equipment and domestically produced equipment. The draft classifies medical equipment into three groups in bidding. Investors can choose one or more criteria for grouping, so as to suit the professional needs and financial capacity of the medical facility. In some special cases, if the equipment does not require a circulation license or technical certification, grouping may not be applied, in order to create flexibility in equipment selection.

A notable point is that the investor has the right to choose the form of grouping. According to the Draft, medical facilities can carry out grouping themselves, invite independent organizations or establish a professional council. However, this process must ensure transparency, publicity and objectivity. Grouping not only helps to shorten the technical criteria in the same group but also makes the bidding process more flexible, avoiding the application of unreasonable criteria that cause difficulties for contractors and medical facilities.

Deputy Minister of Health Do Xuan Tuyen emphasized that the Circular, when issued, must create favorable conditions for medical facilities, ensure transparency and publicity, and at the same time encourage the use of domestically produced products. The Ministry of Health will also promote the application of information technology, strongly decentralize and simplify administrative procedures to support businesses and medical facilities.

In addition, equipment classification also contributes to improving the management capacity of medical facilities. When equipment is clearly classified according to technical and quality standards, purchasing planning will be easier, helping hospitals allocate their budgets reasonably, avoiding duplicate purchases or exceeding demand. The classification system also supports units in evaluating contractor capacity, enhancing competitiveness in bidding, thereby improving the quality of medical equipment used in medical examination and treatment facilities.

Experts in the healthcare sector believe that applying a suitable medical equipment classification system will help improve economic efficiency, reduce unnecessary costs and increase the accountability of healthcare facilities for capital resources. At the same time, with selection criteria based on technical and quality standards, hospitals will have access to advanced, safe and reliable equipment, thereby improving the quality of medical examination and treatment and the patient experience.

The Circular is expected to take effect from January 1, 2026. Its implementation will be an important turning point in the management of medical equipment in Vietnam, opening up opportunities for public and autonomous medical facilities to be more proactive in purchasing equipment, meeting professional needs, while ensuring transparency, publicity and efficiency in bidding.

With the new points in the Draft, experts expect that the Circular will create a solid legal framework, helping the health sector standardize the equipment selection process, encourage businesses to improve product quality and, above all, bring direct benefits to patients.

Source: https://baodautu.vn/phan-nhom-thiet-bi-y-te-nham-nang-cao-hieu-qua-dau-thau-d423088.html