[Blog] Mandatory Digital Labeling of Medical Devices in Uzbekistan: What You Need to Know
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Mandatory Digital Labelling of Medical Devices in Uzbekistan: What You Need to Know
Uzbekistan’s pharmaceutical and medical device industries are undergoing significant regulatory changes with the introduction of mandatory digital labelling. Starting February 1, 2025, medical devices will require digital serialization to enhance traceability, combat counterfeiting, and ensure regulatory compliance.
This article provides a comprehensive overview of Uzbekistan’s Decree of the Cabinet of Ministers No. 149 (02.04.2022) and outlines what manufacturers and importers must do to comply.
Regulatory Framework for Medical Device Labeling in Uzbekistan
Key Regulation: Decree No. 149
The regulation mandates the digital labelling of medicines and medical devices, ensuring that all products in the supply chain are identifiable and traceable.
- Effective Date: February 1, 2025 – Mandatory serialization of medical devices.
- Next Phase: November 1, 2025 – Aggregation of finished products.
Scope: Which Medical Devices Require Digital Labelling?
Medical devices subject to mandatory marking are classified under Appendix No. 1 of Decree No. 149. The key categories include:
- HS Code 3005 – Absorbent cotton, gauze, bandages, and similar products impregnated with pharmaceutical substances or packaged for retail sale.
- HS Code 3006 – Pharmaceutical products specified in Note 4 of this group.
Serialization & Aggregation Requirements
The labelling system requires the application of GS1 2D Data Matrix codes containing key product information.
Serialization – GS1 2D Data Matrix Code
Each unit of a medical device must be uniquely identified using the following encoded data:
- (AI 01) GTIN (Global Trade Item Number): 14-digit numeric code
- (AI 21) Serial Number (SN): 13-digit alphanumeric code
- (AI 91) Crypto Key (Verification Key): 4-digit alphanumeric code
- (AI 92) Crypto Code (Verification Code): 44-digit alphanumeric code
Aggregation – Serial Shipping Container Code (SSCC)
Aggregation marking is required for logistics and supply chain tracking, allowing the grouping of multiple serialized units.
Marking & Labeling Requirements
Manufacturers and importers must comply with strict labelling guidelines to ensure traceability:
- Direct or Label-Based Marking
- The digital identification must be applied directly to the product or on a secure sticker.
- Stickers must be designed so they cannot be removed without damage.
- Sticker Placement & Integrity
- Applied on the production line or in licensed warehouses.
- Must maintain readability throughout the product’s lifecycle.
- Should not obstruct regulatory or safety information.
- Data Content
- Digital identification, product name, product code, and individual serial number.
- No additional images or elements that interfere with readability.
Implementation: What Manufacturers & Importers Need to Do
To comply with the regulation, companies must follow these steps:
Step 1. Sign up with the labelling system
Step 2. Register a product with the National Catalog
Step 3. Contract with an Integrator
Step 4. Order Crypto protection
Step 5. Apply Data Matrix codes
Step 6. Reporting to the ASL Belgisi (Utilization report, Aggregation report)
Step 7. Introduce the products into circulation
Uzbekistan’s mandatory digital labelling of medical devices marks a critical shift toward increased supply chain transparency and patient safety. The ASL Belgisi system ensures end-to-end traceability, making it essential for all stakeholders to adopt serialization and aggregation standards.
To stay compliant, register your products, integrate with the system, and ensure your labelling process meets the new regulatory requirements.
For further details on Uzbekistan’s digital labelling system, visit the ASL Belgisi website.
Want to ensure compliance? Contact us today!
Sources:
The technical and regulatory information in this article was obtained through our request to the Regulatory Authority and support team of National Digital Labeling System – Asl Belgisi, as well as from online sources and visualizations available on the system’s website.
https://help.crpt-turon.uz/hc/ru
Старт обязательной маркировки изделий медицинского назначения – Справочный центр Asl Belgisi