Uzbekistan Medical Device Registration: Sterility and Biological Safety Documentation

1. Key takeaways

Annex 3a of Resolution No. 738 covers sterility and biological safety through four items: item 2.8 sterilization process information, including process validation, microbiological test results or bioburden levels, bacterial endotoxins, the sterility test method, and packaging validation details, applicable to sterile products; item 2.14 stability study reports, where products with a shelf life must attach a national-language translation of the test results and conclusions; item 2.16 the protocol of biological action evaluation studies (tests); and item 2.17 biological safety information. The four items are independent of one another and none can be omitted: submitting only a sterility test report while lacking sterilization process validation is the most common reason for a request to supplement the dossier. Because each item answers a different question about the same product, they should be planned as one evidence program covering process, shelf life, and patient contact rather than as four disconnected documents.

2. Legal basis

3. Expert insights

Insight 1: sterility evidence has two layers, process and result, and only one is usually submitted. The wording of item 2.8 includes both process validation, meaning validation of the sterilization process itself, and results, meaning bioburden levels, bacterial endotoxins, and sterility testing. Process validation demonstrates that the process reliably achieves sterility; results demonstrate that a given batch is sterile. Where only batch release testing is provided and the process validation is missing, the reviewer cannot judge whether conformity will continue across future production, because a single passing batch proves nothing about the stability of the process that produced it. Both layers belong in the dossier for every sterile product.

Insight 2: packaging validation is part of the sterility evidence, not a packaging design file. Item 2.8 places packaging validation details under the same item as sterilization information, because packaging determines whether the sterile barrier is maintained. What packaging validation must demonstrate is that the packaging maintains the sterile state throughout the claimed shelf life, which is why it supports and is supported by the stability studies under item 2.14. Treat the sterile barrier system as a tested component of the product rather than an ancillary design choice, and the two items will reinforce each other in review.

Insight 3: the translation requirement for stability studies is precise down to results and conclusions. Item 2.14 requires products with a shelf life to submit the stability study report together with a national-language translation of the test results and conclusions. This wording deliberately limits the translation workload to the concluding content, while raw data tables may remain in the original language. Manufacturers can use this to control translation costs, but the conclusions must never be omitted, because they carry the reviewer’s decision on the granted shelf life. The shelf life printed on the label must remain within what the translated conclusions support.

Insight 4: the biological evaluation items do not apply to software and IVDs, but do apply to most contacting devices. Item 2.16, the biological action evaluation study protocol, and item 2.17, biological safety information, are explicitly stated not to apply to software and in vitro diagnostic devices. This means patient-contacting devices, implants, and devices containing biological materials all need both items, while standalone software and IVDs do not. Checking this exemption line by line, rather than by analogy, avoids both gaps and unnecessary work; a device with indirect patient contact still generally falls within scope, so the contact pathway should be documented.

4. Practical recommendations

1. For sterile products, prepare the evidence in three layers: process validation, batch results, and packaging validation, with no omission of the process documentation.
2. Align packaging validation with the stability studies so the sterile barrier is demonstrated across the claimed shelf life.
3. Translate only the test results and conclusions of the stability study, retaining raw data in the original language, satisfying compliance while controlling cost.
4. Prepare biological evaluation evidence under items 2.16 and 2.17 for patient-contacting, implantable, and biological-material devices.
5. Keep the labeled shelf life consistent with the stability study conclusions, never beyond what the research supports.

5. Verification checklist

• □ Sterile products include sterilization process validation documentation
• □ Results are submitted for bioburden levels, bacterial endotoxins, and the sterility test method
• □ Packaging validation details are submitted and aligned with the stability study conclusions
• □ Products with a shelf life include the stability report and national-language translation of results and conclusions
• □ Patient-contacting and implantable devices include the biological evaluation protocol and biological safety information
• □ The labeled shelf life matches the stability study conclusions

GRZAN supports manufacturers, importers, and authorized representatives with medical device registration in Uzbekistan, including sterility evidence under item 2.8, stability documentation under item 2.14, and biological evaluation files under items 2.16 and 2.17. For assistance, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.