Uzbekistan Medical Device Clinical Trial Requirements and Evidence Rules

1. Key takeaways

Presidential Decree No. UP-137 establishes a principled requirement: the national registration of medical devices is based on the positive results of clinical trials, and devices with a high probability of risk are subject to mandatory verification based on positive clinical trial results. The only exception concerns devices with a low probability of risk, whose list is approved by the Ministry of Health. At the dossier level, item 2.18 of Resolution No. 738 requires the submission of a clinical effectiveness and safety report, which is generally not required for Class I devices, but sterile, measuring, and invasive Class I devices are excepted. The combination of a principled decree and a detailed dossier rule means that manufacturers must assess clinical evidence obligations at two levels at once: the policy level set by the decree and the document level set by the registration regulation.

Read together, the decree and the regulation give manufacturers a workable sequence: classify the device, test the three exceptions, and only then decide whether new clinical work is needed at all. Devices holding recognized foreign approvals can usually anchor their evidence on the clinical package behind that approval, while devices outside the recognition pathway need an evidence plan that can satisfy item 2.18 without duplicating studies that already exist elsewhere.

2. Legal basis

3. Expert insights

Insight one: being based on positive results is a different question from having to run a local trial. The decree establishes a requirement of basis: the registration decision must be supported by positive clinical results. It does not necessarily require every registration to involve a new clinical trial conducted in Uzbekistan. Existing foreign clinical data, the clinical evidence underlying a foreign approval, and the reference approval under the recognition pathway can all serve as carriers of the positive results, provided the evidence can be verified and linked to the exact configuration submitted.

Insight two: three exceptions narrow the clinical exemption for Class I devices. Item 2.18 sets three exceptions to the Class I exemption: sterile, measuring, and invasive devices. The categories most heavily exported by manufacturers in the Chinese mainland, including single-use sterile consumables, electronic blood pressure monitors, and various invasive catheters, fall squarely within these three exceptions. Before assuming that a low-risk device is exempt from clinical evidence, manufacturers must first pass the three-exception test.

Insight three: clinical evidence and post-market data form one continuum, not two separate segments. Item 2.15 requires a plan for collecting and analyzing post-market safety and effectiveness data. The submission of clinical evidence is therefore not an endpoint but the starting point of a continuum that connects to post-market surveillance. When designing the clinical evaluation, manufacturers should include the post-market data collection plan in the same exercise, so that the two documents link together without gaps.

Insight four: the newly established bioanalytical laboratories target medicinal products, but they signal the direction of regulatory capacity building. The decree provides for bioanalytical laboratories dedicated to bioequivalence studies. Although they primarily serve medicines, this investment shows that the health system is strengthening its technical review capability. The implication for the device side is that the depth of review of clinical and performance data will keep increasing over time.

4. Practical recommendations

1. At project initiation, confirm whether the product falls within the list of devices with a low probability of risk, using the list currently approved by the Ministry of Health.
2. For Class I devices, first self-assess against the three exceptions of sterile, measuring, and invasive, and only then decide whether to prepare clinical evidence.
3. Where foreign clinical data already exist, organize them into a verifiable evidence package covering the trial protocol, reports, ethics conclusions, and statistical conclusions.
4. Compile the clinical evaluation report and the post-market data collection plan together, so that the endpoint of one document connects to the starting point of the other.
5. For high-risk devices, reserve flexible time in the project schedule for the possible triggering of a local clinical study.

5. Verification checklist

• □ It is confirmed whether the product falls within the list of low-probability-risk devices approved by the Ministry of Health
• □ Class I devices have been self-assessed against the three exceptions of sterile, measuring, and invasive
• □ Existing foreign clinical data have been organized into a verifiable evidence package
• □ The clinical effectiveness and safety report has been compiled in accordance with item 2.18
• □ The plan for collecting and analyzing post-market safety and effectiveness data has been prepared in parallel
• □ Flexible time has been reserved in the high-risk device schedule for a possible local clinical study

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, including clinical evidence strategy and dossier compilation. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.