Uzbekistan Post-Market Surveillance of Medical Devices: Cabinet Resolution No. 628 Compliance Guide

1. Key takeaways

Cabinet Resolution No. 628 (adopted on October 4, 2024, effective from October 5, 2024) establishes the post-market surveillance regime for medicines, medical-use products, and medical technical devices, with implementation starting from January 1, 2025. Surveillance is executed by the Center for Drug Safety, and the operating rhythm is fixed by the regulation itself: the surveillance plan for the following month is approved by order of the responsible person no later than the 25th of each month, purchased samples are dispatched to the laboratory within 2 working days, the laboratory issues its report within 5 working days (extended to 15 working days for time-consuming items such as sterility testing), and where a sample is judged nonconforming, the Center takes disposition measures within 3 days. Because these deadlines run in sequence and none of them is long, a single sampling event can move from sample purchase to mandatory corrective action within a matter of weeks, which means manufacturers selling into Uzbekistan need a standing response procedure rather than an ad hoc reaction.

2. Legal basis

3. Expert insights

Insight 1: Surveillance runs on two trigger mechanisms, with planned and unplanned tracks operating in parallel. Planned surveillance follows the monthly plan, which must be approved before the 25th of each month. Unplanned surveillance is information-driven: once the Center receives information about quality, safety, illegal circulation, or adverse reactions from natural persons, legal entities, state bodies, the media, or information and communication channels, the head of the Center must order surveillance to be carried out within 1 working day. In practical terms, a single complaint can launch sampling as early as the next day, so distributors and local representatives should treat every field complaint as a potential regulatory event rather than a routine customer-service matter.

Insight 2: Disposition of nonconforming products is graded, and it escalates step by step. The first level involves suspending use in medical practice, withdrawing the product from circulation, destroying it, and issuing the company a corrective instruction with a fixed deadline. The second level requires temporary mandatory certification of the first 10 batches produced after the nonconformity was found. The third level applies when one or more products of the same enterprise show 2 or more nonconformities within one year: in that case, all products of the enterprise are placed under temporary mandatory certification for a period of 1 year. The escalation logic means that repeated findings carry consequences far beyond the affected lot.

Insight 3: Testing costs are borne by the company, but only when the sample is judged nonconforming. The Center purchases samples using extra-budgetary funds; if the purchased samples are found not to meet regulatory requirements, all related expenditure, including the costs of laboratory studies, is borne by the manufacturing enterprise or by the organization engaged in wholesale trade. This arrangement ties cost directly to outcome and creates a reverse incentive for companies to control production consistency at the source, because every failed sample becomes a billable event as well as a compliance event.

Insight 4: Surveillance results are published and can trigger system-level assessment. Post-market surveillance results are published periodically on the official website of the Center. In cases of nonconformity, the Center may request an interim GxP conformity inspection of the organizations concerned and may carry out an ISO 13485 conformity assessment of device manufacturers. A single failed sample can therefore evolve into a review of the quality management system itself, which is why surveillance findings should always be handled at the system level, not only at the batch level.

4. Practical recommendations

1. Prepare a post-market surveillance response plan covering the internal response procedure, responsible contacts, and deadlines to be observed after a sampling notification is received.
2. Maintain production consistency, especially for the first 10 batches produced after any nonconformity is found, since these batches are the direct object of temporary mandatory certification.
3. Keep a nonconformity register and count nonconformities per enterprise per year, so that the threshold of 2 or more findings within one year is never crossed unnoticed and full-range temporary certification is not triggered by accident.
4. Monitor the surveillance results published on the website of the Center and cross-check them against your own batch records on a regular schedule.
5. Keep the ISO 13485 quality management system in a state that is ready to be assessed, because a failed sample can be transmitted directly into a system-level review.

5. Verification checklist

• □ A post-market surveillance response plan has been prepared, covering the response procedure, contacts, and deadlines
• □ Production consistency controls cover the batches subject to temporary mandatory certification, namely the first 10 batches
• □ A nonconformity register has been established and nonconformities are counted by year
• □ A mechanism for periodically reviewing and comparing surveillance results on the website of the Center is in place
• □ The ISO 13485 system is maintained in an assessment-ready state
• □ The rule that testing costs are borne by the company when a sample is judged nonconforming has been confirmed and internalized

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.