Uzbekistan Medical Device Vigilance Timelines: Reporting Deadlines under Registration No. 3752

1. Key takeaways

The Regulation on the Procedure for Pharmacovigilance of Medicines and Safety Monitoring of Medical Devices, approved by Order No. 18 of the Ministry of Health (December 30, 2025) and registered by the Ministry of Justice under No. 3752 (January 12, 2026), establishes an independent safety monitoring system for medical devices. The core device-side concept is the adverse event (incident): a situation in which a device malfunctions or its characteristics deteriorate in a way that threatens human life or worsens a health condition. Reporting deadlines are set in four tiers by severity: 1 day for death or life-threatening events, 15 days for hospitalization, disability, or congenital anomalies, 60 days for other harm to the human body, and 30 days for ineffectiveness. These tiers apply from the moment a case is registered on the device side, and they are materially tighter than the reporting rhythms most global vigilance systems are built around, which makes early internal triage essential for any manufacturer with products on the Uzbekistan market.

2. Legal basis

3. Expert insights

Insight 1: A 1-day reporting deadline is a strict requirement by any international benchmark. For death or life-threatening events, the report is due within 1 day from the registration of the case. By comparison, ICH E2A allows 7 calendar days for unexpected suspected unexpected serious adverse reactions that are fatal or life-threatening. The Uzbekistan requirement is clearly tighter, which means companies cannot rely on the established pace of their global vigilance process and must operate a dedicated fast track for Uzbekistan, with its own clock, its own triage rule, and its own escalation path that does not wait for the next global reporting cycle.

Insight 2: The reporting obligation rests with the named certificate holder, but the underlying data sits with the manufacturer. Registration No. 3752 assigns obligations to medical and preventive institutions, pharmacies, manufacturers, registration certificate holders, and organizations engaged in sale, use, and storage. For a foreign manufacturer, the party that actually carries the primary reporting duty in front of the regulator is the local legal entity named on the registration certificate, while the underlying safety data originates with the manufacturer. Without a written data exchange agreement and explicit deadlines between the two, the 1-day deadline cannot be met in practice, no matter how mature the manufacturer’s global system is.

Insight 3: Device monitoring runs in parallel with pharmacovigilance, but the concepts are different. On the medicine side the central concept is the adverse reaction; on the device side it is the adverse event (incident), meaning device malfunction or deterioration of characteristics that causes a threat or harm. This distinction determines the data collection scope: device monitoring must capture failure modes, the environment of use, and the maintenance status of the device, not merely the patient response. A vigilance process copied unchanged from a medicines framework will systematically miss the device-specific signals that matter most to the regulator.

Insight 4: Reporting channels are multiple and they extend to the public. The official online services of the Center accept reports from marketing authorization holders, medical and pharmaceutical professionals, and members of the public, through channels that include the government web portal, an instant messaging bot, and a mobile application. Because members of the public can report directly, the response capability of the company at the point of care, including hospitals and distributors, is part of the compliance chain and not an optional courtesy.

4. Practical recommendations

1. Sign a safety data exchange agreement with the local representative that fixes transfer deadlines for each event category, and design the data chain around the shortest deadline of 1 day.
2. Define in the representative’s scope of duties the named reporting owner, a backup contact, and coverage arrangements for weekends and public holidays.
3. Establish a device-specific collection scope for failure modes, covering the failure phenomenon, the environment of use, the maintenance status, and the severity grading of the consequence.
4. Deploy event reporting guidance at the point of care, including hospitals and distributors, since professionals and members of the public can report directly to the Center.
5. Set up internal clocks according to the four deadline tiers of 1 day, 15 days, 60 days, and 30 days, and start the clock at the moment the event is registered.

5. Verification checklist

• □ A safety data exchange agreement has been signed, with the transfer chain designed around the 1-day shortest deadline
• □ The reporting owner, backup contact, and holiday coverage arrangements of the representative have been defined
• □ A device failure mode collection scope has been established, covering phenomenon, environment, maintenance, and consequence
• □ Event reporting guidance has been issued to hospitals and distributors
• □ Internal timing tools have been configured for the four deadline tiers of 1, 15, 60, and 30 days
• □ The device adverse event concept has been distinguished from the medicines adverse reaction concept in the collection scope

Regulatory information verified as of October 29, 2026.

GRZAN provides regulatory support to manufacturers, importers, and authorized representatives seeking medical device registration and post-market compliance in Uzbekistan, including dossier preparation, authorized representative arrangements, vigilance setup, and surveillance readiness. For inquiries, contact info@grzanglobal.com.