Uzbekistan Recognition Pathway: Reference Authorities Eligible for Foreign Approval Recognition

1. Key takeaways

Resolution No. 738 enumerates six categories of foreign regulatory authorities that can support the recognition pathway: the United States Food and Drug Administration (FDA), bodies authorized to issue EU certificates of conformity (CE issuing bodies), the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency of Japan (PMDA), the Ministry of Food and Drug Safety of the Republic of Korea (MFDS), and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA). Presidential Decree No. UP-137 additionally introduces, on the medicinal products side, the standards of WHO Listed Authorities (WLA) and maturity level 4 under the WHO Global Benchmarking Tool (ML4). For devices, recognition follows the list in Resolution No. 738, and eligibility must be confirmed for each specific device, item by item, rather than assumed at the company or brand level.

The distinction matters commercially as well as legally. A European approval obtained from a body outside the six categories cannot be cured by argument or supplementary testing; it can only be cured by obtaining a qualifying approval or by accepting the general pathway with its longer statutory clock and local evidence workload. Portfolio planning should therefore map every marketed device against the six categories before the Uzbekistan project starts, and any device that fails the mapping should be routed directly to the general pathway rather than entered into a recognition application that the center will refuse after consuming review time.

2. Legal basis

3. Expert insights

Insight one: the list names authorities, but the unit of eligibility is the device. Holding one FDA 510(k) clearance does not entitle a different device of the same company to the recognition pathway, and even the registration of the same device with the Health Sciences Authority of Singapore falls outside the list. Eligibility must be assessed at the level of the specific device, the specific model, and the specific approval document, and a portfolio-level assumption will fail at the verification stage.

Insight two: the issuing body of a CE certificate must be verifiable. The wording of the list refers to bodies authorized to issue EU certificates of conformity, and the emphasis is on being authorized to issue. When preparing evidence, manufacturers need to provide documents demonstrating that the issuing body holds the relevant qualification, such as the notified body number and its scope of designation, and cannot rely on a scanned CE certificate alone.

Insight three: the presence of the EMA on the list points to borderline products and centrally authorized products. The EMA mainly conducts centralized assessment of medicinal products, and its relevance on the device side is concentrated on drug-device combinations and borderline products. A manufacturer invoking the EMA as the basis for recognition should first confirm that the product actually falls within the EMA regulatory scope before filing.

Insight four: the WHO standards on the medicinal products side and the device-side list are two separate systems and must not be mixed. The WLA and ML4 standards introduced by Presidential Decree No. UP-137 apply to medicinal products; device-side recognition is based on the six categories of authorities listed in Resolution No. 738. Devices subject to WHO prequalification have a separate 60 working day channel, which is a distinct arrangement from the 15 working day channel for recognition based on the six categories of authorities.

4. Practical recommendations

1. Maintain a register of foreign approvals for every device model, recording the approving authority, approval number, model, specification, manufacturing site, and validity period.
2. Attach to each CE certificate evidence of the qualification of the issuing body, including the notified body number and the scope of designation.
3. Where the EMA is invoked as the basis, confirm that the product falls within the EMA regulatory scope before filing.
4. Distinguish three channels: recognition by the six categories of authorities at 15 working days, WHO prequalification at 60 working days, and epidemic-use IVDs at 30 working days.
5. Ensure foreign approval documents can be verified through public channels, and prepare alternative evidence for documents that cannot be verified.

5. Verification checklist

• □ A register of foreign approvals has been established for each device model
• □ The approving authority falls within the six categories enumerated in Resolution No. 738
• □ The CE certificate is accompanied by evidence of the qualification of the issuing body (notified body number and scope of designation)
• □ Where the EMA is the basis, the product is confirmed to fall within its regulatory scope
• □ The three channels of recognition by the six authorities, WHO prequalification, and epidemic IVD are distinguished
• □ Foreign approval documents can be verified through public channels

GRZAN provides registration support in Uzbekistan for manufacturers, importers, and authorized representatives, including verification of recognition-pathway eligibility against the six categories of reference authorities. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.