Uzbekistan Medical Device Risk Classification: Four Safety Classes and Review Timelines

1. Key takeaways

From January 1, 2026, Uzbekistan classifies medical devices into four safety classes: Class I (low risk), Class IIa (medium risk), Class IIb (high risk) and Class III (highest risk), with no Class IV. The class is not a label; it directly determines three things: the statutory review period (60, 90, 120 and 120 working days respectively), whether a clinical effectiveness and safety report is required (Class I devices generally do not require one, except sterile, metrological and invasive Class I devices), and whether verification of manufacturing conditions and local testing are triggered. The classification judgment should be completed and documented before submission, so that the company is not placed in the passive position of accepting a reclassification by the Center for Drug Safety during review. Because the review clock excludes deficiency responses, legalization, sample transport and clinical work, the working-day figures must be converted into calendar project time with care. A disciplined classification file, built on intended use, invasiveness, duration of use and the presence of a measuring function, is the single most effective instrument for keeping the review on the class the company originally assigned, and it doubles as the evidence base when the agency raises questions about the assigned class. Because the four-class structure entered into force together with the new registration procedure, companies that registered under the earlier rules cannot carry their previous class assignments forward unchanged: the class must be re-derived from the intended use and the exception list of the current regulation, and the derivation must be visible in the dossier.

2. Legal basis

3. Expert insights

Insight one: the mapping between class and statutory period sets the baseline cycle of the project. Under Resolution No. 738, Class I carries 60 working days, Class IIa 90 working days, and both Class IIb and Class III 120 working days. Many companies convert the figure of 120 working days directly into half a calendar year, and this is where scheduling errors begin. The statutory period is a review clock: it does not include the time consumed by deficiency responses, notarization and legalization, sample transport or clinical studies. A realistic plan therefore separates the statutory clock from off-clock activities and sequences them explicitly.

Insight two: Class I is not synonymous with exemption from clinical evidence. Item 2.18 establishes three exceptions for Class I: sterile devices, metrological devices and invasive devices still require a clinical effectiveness and safety report. These three categories overlap heavily with the export volumes of manufacturers in the region: single-use sterile consumables, electronic blood pressure monitors and various invasive catheters all fall into the exceptions. Before assuming a low-risk fast track, companies should run every Class I candidate through the three-exception test, because a missed exception surfaces late in the review as a deficiency that resets the clock.

Insight three: classification evidence must come from use, not from marketing. When judging the class, the intended use, the claimed functions, the role of software and the clinical use setting together constitute the classification evidence. A device described as supporting diagnosis and one described as used for diagnosis may fall into different classes. The approach used by GRZAN is to freeze a list of intended-use statements at the qualification stage, so that all subsequent documents and marketing materials quote the same list. This single control removes most of the ambiguity that reviewers otherwise resolve against the applicant.

Insight four: an under-classified product costs more to fix than an over-classified one. Under-classification means the project was scheduled for 60 working days and the evidence was prepared without clinical requirements. Once the center reclassifies the device to Class IIa or IIb, the period lengthens, clinical evidence must be supplemented, and additional samples may be required. Over-classification by one class only produces a fuller but still acceptable evidence set. Where the class is genuinely borderline, preparing to the higher class is the cheaper form of insurance.

4. Practical recommendations

1. Issue a written Safety Class Determination Statement at the project initiation stage, recording the basis of the judgment (intended use, invasiveness, duration of use, presence of a measuring function).
2. Re-verify every Class I determination against the list of three exceptions: sterile, metrological and invasive.
3. Freeze a list of intended-use statements and require all technical documentation, instructions for use, labels and marketing materials to quote it.
4. In the project schedule, list the statutory period and off-clock activities on separate lines, so that 120 working days is never equated with half a year.
5. For products at a classification boundary, prepare evidence to the higher class and keep a safety margin in the plan.

5. Verification checklist

• □ A safety class has been assigned to every model with a written determination statement
• □ Every Class I determination has been checked against the three exceptions of sterile, metrological and invasive devices
• □ Statutory review periods mapped by class (60, 90, 120 and 120 working days)
• □ Deficiency response, legalization, sample and clinical time listed separately in the project schedule
• □ The intended-use statement list has been frozen and is quoted by all documents
• □ Borderline products have evidence prepared to the higher class

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with risk classification and review scheduling, contact info@grzanglobal.com.