Uzbekistan Medical Device Registration Parties: Holder, Applicant and Authorized Representative

1. Key takeaways

The registration procedure under Resolution No. 738 involves three distinct capacities: the applicant (which may be the developer, the manufacturer, the registration certificate holder, or a legal entity authorized by power of attorney), the registration certificate holder (the rights holder recorded on the certificate) and the authorized representative (a legal entity registered in Uzbekistan that foreign manufacturers must appoint). A foreign manufacturer may retain holder status, but it must appoint a legal entity registered in Uzbekistan as the applicant and authorized representative: the name, tax number, legal address and contact details of that entity must appear on the registration certificate, the instructions for use and the labeling, and submissions are signed with a local electronic signature (e-imzo). The three capacities are not the same concept, and conflating them destabilizes both certificate management and liability allocation. The practical consequence is structural rather than formal: because the e-imzo is issued only to local tax residents, the filing action cannot be performed remotely by the foreign manufacturer, which makes the local representative a hard requirement of the procedure itself. Companies should formalize the division of responsibilities among the three parties in writing at the outset of the project, covering submission scope, fee allocation, data exchange, change conditions and document custody.

2. Legal basis

3. Expert insights

Insight one: the institutional change of August 2025 moved the authorized representative from optional back to mandatory. Under earlier practice, foreign manufacturers could for a period file in their own name and the authorized representative did not appear on the registration certificate or the instructions for use. After Presidential Decree No. UP-137 of August 19, 2025, the role of the representative was re-established: the manufacturer remains the registration holder, but the certificate is obtained in the name of an Uzbek legal entity, whose tax number, legal address and contact details must appear on the instructions for use and the labeling, and which must sign documents with a local electronic signature. Companies holding certificates issued under the old arrangement need to review their representative structure, because certificates that no longer match the current rules complicate renewals, changes and post-market reporting.

Insight two: the electronic signature is the technical lock of the localization requirement. The local electronic signature e-imzo is issued by the tax authorities and is available only to local tax residents. This means the submission action cannot be completed remotely by the foreign manufacturer: no matter how complete the dossier is, without a local representative the electronic filing cannot be executed. This is the technical reason why a foreign manufacturer cannot bypass the local representative, not merely an administrative formality, and it explains why representative selection is a project-critical decision rather than a contracting afterthought.

Insight three: the reporting obligation falls on the named certificate party, and the data chain must run back to the manufacturer. Under registered order No. 3752, the reporting obligation is borne principally by the entity named on the registration certificate, but the underlying safety data on which that entity depends come from the manufacturer. A written data exchange agreement must therefore exist between the two, covering time limits, responsibilities and compliance controls; without it, the shortest reporting deadline of 1 day is not operationally achievable, since the certificate holder cannot report what the manufacturer has not yet provided.

Insight four: representative changes are a frequent source of commercial risk. Changing the representative requires cooperation from the outgoing representative and involves synchronized changes to the registration certificate, the instructions for use, the labeling and the state register. GRZAN recommends appointing a neutral professional third party as representative for high-value equipment, so that the manufacturer can manage several distribution channels in parallel without tying market access to the commercial relationship with a single importer.

4. Practical recommendations

1. Sign a separate Authorized Representative Agreement in addition to the commercial contract, covering submission scope, fee allocation, change conditions and responsibility for document custody.
2. Sign a Safety Data Exchange Agreement at the same time, setting time limits for the transmission of adverse event and restriction information, so that the shortest 1-day reporting requirement can be met.
3. Verify the e-imzo holdings of the representative and confirm that it has local electronic signature capability.
4. Define in the agreement the trigger conditions for a representative change and the cooperation obligations, to avoid being blocked during an exit.
5. For high-value equipment, consider a neutral professional institution as representative to preserve channel flexibility.

5. Verification checklist

• □ The three capacities of registration certificate holder, applicant and authorized representative have been distinguished and agreed in writing
• □ The authorized representative is a legal entity registered in Uzbekistan with a local electronic signature (e-imzo)
• □ The tax number, legal address and contact details of the representative appear on the instructions for use and the labeling
• □ The power of attorney has been notarized and apostilled or consularized
• □ For a power of attorney drawn up in a non-generally accepted language, the accuracy of its Uzbek translation has been notarized
• □ A safety data exchange agreement has been signed, supporting the shortest 1-day reporting deadline

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with representative appointments and e-imzo filing, contact info@grzanglobal.com.