Uzbekistan Medical Device Retail Notification Regime: From Licensing to Filing

1. Key takeaways

Presidential Decree No. UP-137 (August 19, 2025) removed the licensing requirement for the retail trade in medical devices, and the activity is now conducted through notification, that is filing, with the competent authority. This is a substantive liberalization on the circulation side, but it does not amount to the removal of compliance obligations: retail entities must still complete the filing action, and the products they sell must still have completed state registration and have a lawful origin. Interpreting the abolition of licensing as free sale without obligations is the most common misunderstanding in the distribution chain, and it is a misunderstanding that can cost a retailer its access to the market when enforcement begins. In practice, the filing confirmation is the first document an inspector will ask for, which makes it the cheapest compliance asset in the retail chain.

2. Legal basis

3. Expert insights

Insight 1: Moving from licensing to filing changes the intensity of prior approval, not the existence of compliance. Under a licensing regime, a subject may operate only after approval has been granted; under a filing regime, a subject may operate once it has fulfilled the notification duty. But filing is still an action that must be completed, and the other requirements of the activity remain unchanged: the products must be registered, their origin must be lawful, and the digital labeling must be compliant. The administrative threshold drops, while the substantive obligations stay exactly where they were. For manufacturers, the practical consequence is that the quality of the filing of each retail partner is a channel-management issue, because a partner that is not properly filed puts the whole supply relationship at risk.

Insight 2: Liberalization at the circulation end and tightening at the market access end are two faces of the same reform. Presidential Decree No. UP-137 abolished retail licensing and, in the same instrument, established mandatory state registration of devices with a four-tier classification. This is not a contradiction but a shift of regulatory focus: resources are being moved away from approving business qualifications in advance and toward product access control and post-market regulation. Companies should therefore expect fewer barriers to enter as traders and far more scrutiny of the products themselves. The same decree that lowered one barrier raised another, and companies that read only the headline risk missing the half of the reform that affects their products.

Insight 3: The retail stage still performs the disposal action of the digital labeling system. Under the Asl belgisi system, the code is disposed of at the retail stage through the receipt, and from July 1, 2026, a receipt cannot be issued when code verification fails. This means that although retail entities no longer need a license, they carry the last link of the traceability chain: the connection between their cash register systems and the traceability system becomes a new compliance point, and a failed verification at the checkout directly blocks the sale. Retailers should therefore treat the receipt as a compliance document, not a commercial formality, and test the verification flow before the deadline arrives.

Insight 4: The opening of retail can accelerate channel expansion and thereby amplify registration and traceability pressure. Once the retail threshold is lowered, the number of sales endpoints grows and the traceability chain becomes longer, which raises the probability that unlabeled or noncompliant products are identified. For manufacturers, this raises the importance of channel management: every endpoint in the network must be able to handle labeled products correctly, because a failure at any single endpoint is visible in the national traceability data. Manufacturers can also use the traceability data as a channel health indicator, since code activity at an endpoint reflects whether the product is actually moving through legal channels.

4. Practical recommendations

1. Ensure retail partners complete the filing action before starting business, and retain the filing confirmation as evidence; a copy should be kept in the channel management file together with the agreement.
2. State in agreements with retail partners that the products sold must have completed state registration, have lawful origin, and be labeled in compliance with the digital system.
3. Provide retail partners with handling guidance for labeled products, focusing on code scanning and receipt issuance; training at the checkout level is more effective than a written manual alone.
4. Assess the carrying capacity of the traceability chain in parallel with channel expansion, so that code status is never interrupted along the way.
5. Establish a spot-check mechanism for endpoint compliance, focusing on unregistered products, unlabeled products, and products with noncompliant labels.

5. Verification checklist

• □ Retail partners have completed the filing and retained the filing confirmation
• □ Agreements state that products must be registered, of lawful origin, and labeled in compliance
• □ Retail partners have received handling guidance for labeled products, covering scanning and receipt issuance
• □ The carrying capacity of the traceability chain has been assessed before channel expansion
• □ A spot-check mechanism for endpoint compliance has been established
• □ It has been confirmed that abolition of licensing does not mean abolition of compliance obligations

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.