Scenario: a company wants to import new German ultrasound machines for Vietnamese distribution. It asks: how are medical devices classified, what circulation licences apply, and are prices regulated?
Medical device classification: risk levels drive regulation
Medical devices classify by risk level (low to high: types A, B, C, D) — higher risk means tighter regulation. Classification is performed by device owners (manufacturers) under classification principles and rules, subject to regulatory review. Correct classification is the first and most important step: misclassification (downgrading risk to dodge regulation) is an administrative violation voiding all subsequent circulation procedures. The ultrasound machines above typically sit at medium risk — check specific classification rules rather than mechanically applying “experience” from other products.
Circulation conditions: declaration and registration
Medical devices circulate in Vietnam only where meeting conditions: type A (low risk): standard-declaration procedures; types B, C, D: circulation registration certificates (circulation numbers). Registration dossiers include technical documentation, assessment results (clinical trials where needed), manufacturer quality certificates, and for imports — evidence of authorised circulation in manufacturing or reference countries. Importing and distributing enterprises must meet medical-device trading conditions (personnel, warehousing, traceability systems). Circulating devices without declaration or registration numbers is an administrative violation; unclear-origin or substandard devices causing serious consequences may attract criminal liability.
Price management and device bidding
Device prices follow: price declaration before circulation and upon price changes; public pricing on regulator portals — hospitals and medical establishments procuring must reference declared prices and never exceed them in state-funded bidding. For device bidding into public hospitals: the Bidding Law 22/2023/QH15 applies; bid dossiers must not set tailor-made criteria for one brand (e.g., technical specs only one model meets); splitting packages to dodge competitive bidding violates the law. Distributors should build consistent, transparent pricing policies — unreasonable price gaps between hospitals signal bidding irregularities inviting inspection.
Frequently asked questions
May used medical devices be imported?
Strictly limited: used medical devices face special management, many types banned from import or importable only under tight conditions (service life, quality inspection). Check specific lists before signing import contracts.
Is diagnostic AI software a medical device?
It can be — diagnostic and therapeutic software (software as a medical device) is managed as medical devices with corresponding risk classification, requiring declaration and registration procedures. No “underground” circulation as ordinary software.
Are device maintenance and calibration mandatory?
Yes — medical establishments must periodically maintain and calibrate equipment per manufacturer rules and technical standards. Using overdue-calibration equipment causing diagnostic errors breaches professional rules; in incidents, this aggravates liability.
This article has been quality-reviewed by the FLAW AI Legal Council.