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Cabinet of Ministers Resolution No. 738 was adopted on 24 November 2025 and takes effect on 26 February 2026, replacing the framework that had governed medical device registration since 2018. State registration is administered by the Center for Pharmaceutical Products Safety under the Ministry of Health of the Republic of Uzbekistan, and no medical device, in-vitro diagnostic or item of medical equipment may be placed on the market until it is entered on the State Register.

The first consequence for any applicant is classification. Devices are assigned to one of four safety classes on a risk basis — intended use, invasiveness, duration of contact with the body, whether the device is active or supplies energy, and, for in-vitro diagnostics, the consequences of an incorrect result. The class determines how much evidence the dossier must contain, whether laboratory testing or expert evaluation is required, and how long review takes. Getting the class wrong is the most expensive early mistake, because the file has to be rebuilt to the standard of the correct class.

The second is the choice of procedure. The national procedure is the default and requires a complete technical file: device description and variants, conformity with essential principles, risk management, design verification and validation, biocompatibility, electrical and software safety where relevant, sterilisation and shelf-life data, clinical evaluation, quality-system evidence, and instructions for use and labelling in Uzbek and Russian. Alongside it, Resolution 738 introduces a recognition procedure for devices already approved by a reference regulator — the US FDA, an EU CE marking, the UK MHRA, Japan's PMDA or Korea's MFDS. Recognition relies on the existing approval rather than reassembling the underlying evidence, which shortens both preparation and review, but it applies only to the exact product, model range and intended use that the foreign certificate actually covers. A certificate that names a narrower configuration than the one you intend to sell will not carry the whole range.

The third is representation. A manufacturer without a legal presence in Uzbekistan must appoint a locally established Authorized Representative, who is named in the application and recorded against the device on the State Register. The appointment is made by Power of Attorney; filings are signed electronically with an e-imzo signature. The representative is the authority's point of contact for the life of the registration, keeps the technical file available, receives complaints and adverse-event reports, and files variations and renewals.

The fourth is duration. A registration certificate is valid for five years. During that period the holder carries post-market obligations — vigilance reporting, field safety corrective actions, and keeping the registered particulars accurate through variations whenever the manufacturer, manufacturing site, device name, configuration, labelling or intended use changes. Renewal is a process with its own lead time, not a formality at the end.

For portfolios already registered under the previous framework, the practical question is transition: which certificates remain valid, what has to be refiled, and in what order. That is worth mapping before February 2026 rather than after.