Uzbekistan Registration Holder Identity: Foreign Manufacturer Rights and the Local Legal Entity

1. Key takeaways

In Uzbekistan, a foreign manufacturer can retain the identity of the registration holder, but the registration certificate is obtained in the name of a legal entity registered in Uzbekistan. The TIN, legal address and contact details of that legal entity must appear in the instructions for use and on the labeling, and its name is published alongside the manufacturer in the state register. In other words, holding the qualification and being the submission subject are separated: the rights belong to the foreign manufacturer, while the certificate carrier is a local legal entity. Understanding this separation is the precondition for designing both the market access structure and the commercial agreements around it. It explains why the certificate can never simply be treated as the property of the local partner, and why the local partner can never treat the certificate as an asset it freely controls. Rights and carrier are deliberately split by the regulatory framework, and every contract, labeling layout and register entry should reflect that split consistently. Where the three public touchpoints — the instructions for use, the labeling and the state register — tell the same story, downstream customers, customs authorities and hospital procurement teams can verify the supply chain without friction. Where they diverge, every verification step becomes a potential point of delay or challenge. The separation also has a due diligence dimension. Before signing with any local entity, the manufacturer should confirm its registration status, tax standing and operational capacity, because once its TIN and legal address are printed on the labeling of every unit shipped, replacing it becomes a coordinated exercise across documents, registers and commercial agreements rather than a simple swap.

2. Legal basis

3. Expert insights

Insight 1: the applicant may be the developer, the manufacturer, the certificate holder, or an authorized legal entity — all four identities are lawful. Annex 2a of Resolution No. 738 lists four categories of entities that may file the application. This breadth gives companies room to design the access structure: the certificate can be held directly under the manufacturer arrangement, or carried by a local subsidiary or a third-party agency, depending on a combined assessment of tax treatment, channel strategy and risk management. There is no single correct answer; the choice should follow the commercial architecture rather than dictate it.

Insight 2: the local legal entity appears in three places, forming a visible rights structure. After August 2025, the TIN, legal address and contact details of the local legal entity must appear in the instructions for use and on the labeling, and its name is published alongside the manufacturer in the state register. These three public touchpoints jointly shape market perception of who is accountable for the product, and they determine who is examined by downstream customers and regulators. Keeping all three synchronized is therefore not a cosmetic exercise but a compliance requirement in its own right.

Insight 3: the representative cannot dispose of the certificate independently of the authority granted by the manufacturer. As the applicant and authorized representative, the local legal entity cannot dispose of the registration certificate on its own without the approval of the manufacturer granted through a power of attorney. This arrangement protects the rights of the foreign manufacturer, but it also means that once the authorization relationship breaks down, disposal of the certificate can reach a deadlock. Disposal clauses in the agreement therefore carry particular weight and should be negotiated before signature, not after a dispute arises.

Insight 4: the register entry is the public disclosure of the rights structure. Article 14 requires the state register information to be published on the website of the Ministry of Health. When importers and hospital procurement teams perform their checks, they look at the manufacturer and representative combination shown in the register. Any inconsistency between the register and the actual supply chain will be exposed at the verification stage, regardless of what the paper documents say.

4. Practical recommendations

1. Define the combination of registration holder and applicant or representative at the access structure design stage, and record it in a tripartite agreement.
2. Verify consistency across the instructions for use, the labeling and the register (TIN, legal address, contact details).
3. State the disposal rules for the certificate in the authorization agreement, including renewal, variations, cancellation and dispute resolution.
4. When changing the representative or holder, update the instructions for use, the labeling and the register simultaneously to avoid information gaps.
5. Check the register entry together with importers and distributors to confirm it matches the actual supply chain.

5. Verification checklist

• □ The identity combination of registration holder and applicant or representative has been defined
• □ The instructions for use and labeling state the TIN, legal address and contact details of the local legal entity
• □ The manufacturer and representative information in the state register entry matches reality
• □ The authorization agreement states the disposal rules for the certificate (renewal, variation, cancellation, disputes)
• □ A synchronized update mechanism for changing the representative or holder has been established
• □ The register entry has been checked with importers and distributors

GRZAN supports manufacturers, importers and authorized representatives with medical device registration, holder structure design and market access in Uzbekistan. For assistance with your product portfolio, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.