Uzbekistan Low-Probability-Risk Device Exemption List and Class I Relief

1. Key takeaways

Devices with a low probability of risk represent the only registration relief arrangement left by Presidential Decree No. UP-137, and their list is approved by the Ministry of Health; the individual items have not been enumerated in the publicly available text of the decree. As a companion rule, item 2.18 of Resolution No. 738 provides an operational test at the dossier level: Class I devices generally do not require a clinical effectiveness and safety report, but sterile, measuring, and invasive devices are three exceptions. When invoking the exemption, manufacturers should use the three exceptions of item 2.18 as a self-assessment tool and should treat the current Ministry of Health list as the controlling reference, because the list itself is not published in the decree and its content can change over time.

The two-level structure also means the exemption question should be answered early in the project, not at submission. A device that qualifies for relief on both the clinical and sample dimensions saves budget as well as time, while a device that fails the three exceptions needs those budgets reinstated before the dossier is compiled. Treating the three-exception test as an initiation-stage gate keeps the evidence plan, the sample plan, and the schedule consistent with each other from the first week of the project onward.

2. Legal basis

3. Expert insights

Insight one: the list authorization and the dossier-level test operate at two different levels, and the one companies can actually use is the latter. The low-probability-risk list approved by the Ministry of Health is a product list, while the three exceptions of item 2.18 form an evidence test. While the list has not been published, the practical step available to companies is to self-assess whether their Class I determination survives the three exceptions. This is why GRZAN treats the three exceptions as a mandatory self-check item in its projects.

Insight two: the two sets of three exceptions apply the same logic twice. The clinical exemption exceptions of item 2.18 and the exceptions to the sample exemption both point to the same three categories: sterile, measuring, and invasive devices. This is not a coincidence. The risk characteristics of these three categories make their actual risk higher than the nominal Class I level, so they do not enjoy the relaxed Class I treatment in either the evidence dimension or the sample dimension.

Insight three: the Ministry of Health also maintains a separate list of medical devices for the diagnosis and treatment of rare diseases. Under Article 6 of the Law on Medicinal Products and Pharmaceutical Activities, the Ministry of Health is responsible for compiling that list, and Presidential Decree No. UP-137 further names medicines and devices for rare diseases as exempt from the GMP and ISO:13485 requirements. The two lists differ in nature, one supporting circulation and the other exempting quality system certificates, but both are led by the Ministry of Health, and companies should confirm each one separately when making inquiries.

Insight four: lists are dynamic, and the current version must be checked at the time of invocation. Lists approved by the competent authority are adjusted with industrial policy and clinical needs. A company relying on a list version obtained years ago may find that it no longer reflects reality. The correct practice is to confirm the current list with the Ministry of Health or the Drug and Device Safety Center through the authorized representative before submission.

4. Practical recommendations

1. Make the three items of sterile, measuring, and invasive a mandatory self-check in the Class I determination and record it in the safety class determination statement.
2. Before submission, confirm the currently approved list of low-probability-risk devices with the Ministry of Health through the authorized representative.
3. Where the three exceptions apply, prepare both the clinical evidence and the samples to the higher standard, not just one of the two.
4. For rare-disease products, verify separately the applicability of the rare-disease device list and of the quality system certificate exemption.
5. Record the list version together with the date of the inquiry in the project file to support later review.

5. Verification checklist

• □ The Class I determination self-check is complete against the three items of sterile, measuring, and invasive
• □ The currently approved list of low-probability-risk devices has been confirmed with the Ministry of Health
• □ Where the three exceptions apply, the clinical evidence and the samples are prepared in parallel to the higher standard
• □ For rare-disease products, the circulation list and the quality system certificate exemption are verified separately
• □ The list version and the date of the inquiry are recorded in the project file
• □ The safety class determination statement contains the self-check conclusion on the three exceptions

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, including exemption analysis and safety class determination. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.