Uzbekistan Medical Device Registration: MoH Compliance Guide
With a population exceeding 38 million and a booming healthcare sector, Uzbekistan is one of Central Asia’s most lucrative markets for medical technologies. However, foreign manufacturers cannot simply export their products; they must first successfully complete the Uzbekistan Medical Device Registration process.
Regulated by the Ministry of Health (MoH) and the Center for Safety of Pharmaceutical Products, the registration process ensures all devices meet strict national standards for safety and efficacy. This guide provides an expert-backed roadmap to classifying your device, choosing the right registration pathway, and achieving rapid market access.
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The Regulatory Framework & Classification
Before beginning the Uzbekistan medical device registration process, you must accurately classify your product. The MoH classifies medical devices into four risk-based categories. Incorrect classification is the leading cause of dossier rejection.
| Risk Class | Risk Level | Device Examples |
| Class I | Low Risk | Basic surgical instruments, bandages, non-sterile consumables |
| Class IIa | Low-Medium Risk | Diagnostic equipment, infusion pumps, ultrasound devices |
| Class IIb | Medium-High Risk | Ventilators, surgical lasers, intensive care monitors |
| Class III | High Risk | Pacemakers, custom-made implantable devices, stents |
Note: Foreign manufacturers are legally required to appoint a local Authorized Representative (AR) in Uzbekistan. This entity acts as the legal liaison between you and the regulatory authorities.
The Registration Pathways: National vs. Simplified (Fast-Track)
Uzbekistan offers two distinct pathways for medical device registration:
1. The National Procedure (Standard Route)
This procedure involves a full examination of the registration dossier and local laboratory testing of medical device samples.
Timeline: Typically takes 6 to 12 months (120 working days, excluding time taken to respond to official remarks).
2. The Simplified Procedure (Recognition / Fast-Track)
If your device is already approved by highly regulated global authorities, Uzbekistan allows a simplified registration process through recognition. This drastically reduces testing requirements and timelines. You qualify for the fast-track route if your device holds approval from:
Europe: CE Marking or European Medicines Agency (EMA)
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
South Korea: Ministry of Food and Drug Safety (MFDS)
UK: Medicines and Healthcare products Regulatory Agency (MHRA)
Timeline: Can be completed in as little as 45 working days (15 days for regulatory review).
Step-by-Step Uzbekistan Medical Device Registration Process
Appoint a Local Authorized Representative: Sign a legalized Power of Attorney (PoA) with a local Uzbek entity to handle submissions.
Dossier Preparation & Translation: Compile the technical file and translate necessary documents (like the Instructions for Use – IFU) into Russian and Uzbek.
Submit Samples: Unless exempted (e.g., Class I non-sterile, or utilizing the fast-track route), provide physical samples of the device for local laboratory testing.
Expert Evaluation: The MoH conducts a primary screening, followed by a specialized technical and clinical evaluation.
Certificate Issuance: Upon successful review, the MoH issues a Registration Certificate valid for 5 years.
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Documents Required for Registration
A complete, properly formatted dossier is vital to avoid delays. Key documents include:
Legalized Power of Attorney (PoA)
Free Sale Certificate (FSC) or equivalent approvals (FDA, CE, etc.)
Legalized copy of your ISO 13485 certificate
Technical description, risk management file, and clinical evaluation reports
Instructions for Use (IFU) and proposed mock-ups of local packaging
Protocols of laboratory, technical, and preclinical tests
New Requirement: ASL BELGISI (QR-Marking)
Uzbekistan has introduced mandatory traceability markings for medical devices known as ASL BELGISI (similar to UDI systems). Depending on your device’s HS code, your local Authorized Representative must register the batch in the national digital marking system and apply QR codes to individual units prior to importation.
Cost and Validity
The cost of Uzbekistan medical device registration depends on the device class, the number of variants, and whether local clinical testing is required. The government charges specific state fees (calculated in BCV – Basic Calculated Values) per item.
The final Registration Certificate is valid for 5 years. Renewal procedures must be initiated at least 3 to 9 months before expiration.
How Operon Strategist Helps You Succeed
At Operon Strategist, we provide end-to-end regulatory consulting tailored for Uzbekistan:
Product classification & regulatory strategy
Documentation preparation (technical file & dossier)
Authorized Representative support
Submission & follow-up with authorities
ISO 13485 compliance support
Faster approval with minimized risk
💡 Need a local Authorized Representative?
Contact Operon Strategist to establish your legal presence, manage your technical dossier, and handle ASL BELGISI markings seamlessly.
FAQ's
Is Uzbekistan medical device registration mandatory?
Yes. All medical devices must be registered with the Ministry of Health before they can be legally imported and sold in Uzbekistan.
Do I need a local Authorized Representative?
Yes. Foreign manufacturers must appoint a registered local entity to act as their Authorized Representative via a legally binding Power of Attorney.
How long does the registration process take?
The standard national procedure takes 6 to 12 months. The simplified fast-track procedure (for CE/FDA approved devices) takes about 45 days.
What is the validity of the registration certificate?
The registration certificate is valid for 5 years and must be renewed before expiration to maintain market access.
What is the ASL BELGISI system?
It is Uzbekistan’s mandatory digital QR-marking (UDI) system used to ensure the authenticity and traceability of specific medical devices imported into the country.