Local medical equipment manufacturers have collectively submitted petitions to regulatory bodies and major hospitals, highlighting technical barriers that disadvantage domestic products in high-tech medical supply tenders.
The core issues raised by enterprises include:
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Imposition of simultaneous international certifications: Some procuring entities require products to hold both CE (Europe) and FDA (USA) certifications concurrently. Experts argue this is an unnecessary “technical barrier,” as these are foreign market-access standards rather than specific technical specifications for the Vietnamese market.
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Risk of oligopoly and budget waste: Setting overly stringent conditions eliminates domestic bidders from the outset, creating an “oligopoly” for foreign brands. This drives up product prices, leading to losses in the state budget and health insurance funds, while increasing the financial burden on patients.
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Contradictions in professional evaluation: Businesses stated that domestic products have undergone rigorous clinical trials on Vietnamese patients and are licensed by the Ministry of Health. Hospitals prioritizing foreign certificates over actual clinical results in Vietnam is seen as a lack of professional objectivity.
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Inconsistency with Circular 57: Under the latest regulations, products only need to meet technical standards and hold at least one Certificate of Free Sale (CFS) from advanced nations to be classified in the highest quality group (Group I). Requiring additional secondary certifications does not enhance quality but merely serves to exclude local bidders.
In response to these petitions, representatives from several major hospitals stated they would review tender documents, maintaining the principle of prioritizing treatment quality while complying with new medical device classification regulations.