Uzbekistan Authorized Representative for Medical Devices: Role, Duties and Selection

1. Key takeaways

Foreign manufacturers entering the Uzbekistan market must appoint a legal entity registered in Uzbekistan as their authorized representative. The role of the representative goes far beyond filing paperwork: the representative must sign submission documents with a local electronic signature, receive correspondence and decisions issued by the Center, have its taxpayer identification number, legal address and contact details printed in the instructions for use and on the labeling, support post-market obligations where required (including adverse event reporting and recall coordination), and where applicable conclude an agreement with the national digital coding operator and register every imported batch. The representative is not a mail receiver; it is the hub of the entire market access structure. Every downstream activity depends on it. Registration submissions cannot be filed without the representative, because the local electronic signature is available only to local tax residents. Imports cannot clear and be marked without the representative, because coding agreements and batch registration sit with the local entity. Post-market duties cannot be discharged without the representative, because the named holder of the registration certificate carries the reporting obligations. Manufacturers that treat the appointment as a formality usually discover the consequences later: dossiers that cannot be submitted, adverse event deadlines that are missed, and shipments that stall because coding obligations were never arranged. Selecting and contracting the right representative is therefore the first structural decision of an Uzbekistan market entry project, and it deserves the same rigor as the technical dossier itself.

2. Legal basis

3. Expert insights

Insight 1: the technical lock of the representative is the electronic signature, not the power of attorney. The local electronic signature system e-imzo is issued by the tax authorities and is provided only to local tax residents. This means that without a local representative, the act of submission cannot be completed at a technical level. The design is more rigid than a purely administrative requirement, because it implements the principle that foreign manufacturers cannot submit on their own at the infrastructure level rather than at the paperwork level. No notarized power of attorney can substitute for it, and no workaround exists short of appointing a local legal entity. When screening candidates, the first verifiable question is therefore not whether the agency holds authorization letters, but whether it already operates a functioning e-imzo credential under its own taxpayer identification number.

Insight 2: the responsibility lock of the representative is the post-market reporting duty. Under the order registered with the Ministry of Justice as No. 3752, reporting obligations are borne primarily by the named holder of the registration certificate, and the shortest deadline is 1 day for fatal or life-threatening events. A one-day deadline means the representative must be able to receive, assess and escalate events at any time, rather than processing them in monthly batches. This capability item is the most frequently overlooked when manufacturers screen representatives, because it is invisible at the signing stage and only surfaces when an incident occurs. Contractual response commitments, staffing and after-hours contact channels should be verified during selection.

Insight 3: the commercial lock of the representative is the difficulty of changing representatives. Replacing a representative requires the cooperation of the incumbent and involves synchronized changes to the registration certificate, the instructions for use, the labeling and the state register entries. Where the representative is also the importer, commercial disputes transmit directly into market access risk. GRZAN typically recommends a neutral third-party professional agency as the representative on high-value equipment projects, so that the manufacturer can manage multiple distribution channels in parallel without tying the certificate to any single commercial counterparty.

Insight 4: the traceability lock of the representative is the coding agreement. Devices subject to national UDI coding require the representative to conclude an agreement with the national digital coding operator and to register every imported batch, and coding must be completed before import. This extends the duties of the representative into the supply chain: insufficient capability on the coding side directly affects shipment rhythm, delivery schedules and the ability of distributors to sell. Coding readiness should therefore be assessed with the same weight as regulatory experience when comparing candidate agencies.

4. Practical recommendations

1. Apply four capability thresholds when screening representatives: local legal entity status, electronic signature capability, post-market emergency response capability, and coding operation capability.
2. Define response deadlines for the representative in the agreement, especially for the adverse event reporting chain (the shortest statutory deadline is 1 day).
3. Use a neutral third-party professional agency as the representative for high-value equipment to preserve channel flexibility.
4. Specify in the agreement the trigger conditions and cooperation obligations for changing the representative, and document the handover of files and data on exit.
5. Establish an annual evaluation mechanism for the representative, incorporating response speed and compliance records into the assessment.

5. Verification checklist

• □ The representative is a legal entity registered in Uzbekistan and holds a local electronic signature (e-imzo)
• □ The TIN, legal address and contact details of the representative appear in the instructions for use and on the labeling
• □ The agreement defines response deadlines for the adverse event reporting chain
• □ For devices subject to coding, the representative has concluded an agreement with the national digital coding operator
• □ The agreement defines trigger conditions, cooperation obligations and data handover for changing the representative
• □ An annual evaluation mechanism for the representative has been established

GRZAN supports manufacturers, importers and authorized representatives with medical device registration, authorized representative services, fee planning and post-market compliance in Uzbekistan. For assistance with your product portfolio, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.