Uzbekistan Medical Device Regulatory Authority: Ministry of Health and the Center for Drug Safety

1. Key takeaways

The technical review of medical device national registration in Uzbekistan is carried out by the Center for Drug Safety, a state institution under the Ministry of Health and the working body of the Pharmaceutical Industry Development Agency (Uzpharm). The center is responsible for national registration, quality control, standardization and certification, and it maintains the state register. The registration certificate records the authorization of the Ministry of Health for the use of the device in medical practice. When engaging with the system, companies must distinguish three layers: the Ministry of Health is the authorizing body, the Pharmaceutical Industry Development Agency is the sector regulator, and the Center for Drug Safety is the executing agency. Dossier submission, deficiency responses, receipt of decisions and post-market reporting are all addressed to the Center for Drug Safety. Because the same institution combines registration, quality control, standardization, certification and post-market surveillance functions, the technical parameters submitted at the registration stage become the reference baseline for post-market sampling, and any non-conformity found after the product is on the market can be traced back directly to the registration dossier. A registration submission should therefore be treated as a living technical record rather than a one-time deliverable, and every document prepared for the agency should be internally consistent with the dossier as filed.

2. Legal basis

3. Expert insights

Insight one: the renaming of the executing agency is a trap in due diligence. In older public materials the institution appeared under the name State Center for Standardization and Examination of Medicines, Medical-Use Products and Medical Equipment, while its current official name is the Center for Drug Safety. Old contracts, old powers of attorney and old instructions for use that still carry the former institution name may need to be uniformly updated when a new application is filed. When GRZAN takes over a legacy project, the first step is to verify that all institution names across the document set refer to the same legal entity, because a mismatch between the named addressee and the current executing agency can cause an application to be returned for formal correction.

Insight two: one institution carrying four functions means data continuity. The Center for Drug Safety is simultaneously responsible for registration, quality control, standardization and certification, and it also receives post-market surveillance and pharmacovigilance data. The direct consequence is that the technical parameters submitted at the registration stage become the comparison baseline for post-market sampling, and a non-conformity identified by post-market surveillance can be traced directly back to the registration file. Companies cannot treat the registration dossier as a one-time deliverable; it must remain accurate as the product, the label and the manufacturing process evolve.

Insight three: the state register is the public record of the registration right. The Center for Drug Safety maintains the register of issued registration certificates and publishes it on its official website, recording the certificate number, validity period, manufacturer and authorized representative. The verification actions performed by importers and by hospital procurement teams all point to this public record. After a certificate is received, the company should still verify that the register entry matches the physical certificate and the product labeling, since discrepancies between the register, the certificate and the label create avoidable compliance findings during import checks and tenders.

Insight four: the division between legislative authorization and executive review determines the remedy path. The registration certificate records the authorization of the Ministry of Health, while the technical judgment is made by the Center for Drug Safety. When a company disagrees with a review conclusion, it should distinguish whether the disagreement concerns the technical judgment or the procedural execution, because the two categories involve different communication counterparts and different remedies. Mixing the two channels in one objection letter typically delays a substantive response.

4. Practical recommendations

1. Establish a single-point engagement mechanism: the authorized representative communicates with the Center for Drug Safety uniformly, so that parallel contacts from the manufacturer and the importer do not create inconsistent statements.
2. Screen all legacy documents for old institution names and update them to the current official name before submission.
3. Archive the technical parameters submitted at the registration stage so they can serve as the internal baseline for post-market sampling comparisons.
4. After obtaining the certificate, verify the state register entry line by line against the certificate number, validity period, manufacturer and authorized representative information.
5. Keep post-market reporting and registration changes on separate channels, with separate internal ledgers that are cross-checked periodically.

5. Verification checklist

• □ The three-layer division between the Ministry of Health (authorizing body), the Pharmaceutical Industry Development Agency (sector regulator) and the Center for Drug Safety (executing agency) has been mapped
• □ The unified counterpart for submission, response, receipt and reporting has been confirmed as the authorized representative
• □ Institution names in all historical documents have been updated to the current name
• □ Registration technical parameters have been archived and are available for post-market sampling comparison
• □ State register entries, the registration certificate and the physical label are consistent in all three respects
• □ Separate internal ledgers for post-market reports and change applications have been established

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with engaging the Center for Drug Safety and national registration, contact info@grzanglobal.com.