Uzbekistan Medical Device Metrology Approval and Conformity Assessment

1. Key takeaways

In Uzbekistan, a medical device with a measuring function typically has to travel three parallel tracks: national registration of the medical device (Center for Drug Safety, Resolution No. 738), type approval of measuring instruments or metrological certification (the Technical Regulation Agency and the national metrology institute, under the Law on Metrology), and conformity assessment (the national ISO:13485 conformity certificate mandatory from July 1, 2027 under Presidential Decree No. UP-137). The three procedures are executed by different authorities and produce different documents; they cannot substitute for one another, and running them sequentially stretches the project cycle beyond any acceptable length. Each track also has its own judge: the registration track assesses the safety and performance of the device, the metrology track assesses the accuracy characteristics of the measuring function, and the conformity track assesses the quality management system behind the product. Because the evidence burden of the metrology track feeds back into the registration track, a product recognized as a metrological Class I device carries heavier clinical evidence and sample obligations than an ordinary Class I device. Planning the three tracks on a single master schedule, with shared technical documentation and separately issued reports, is the only way to reach the market within a competitive timeframe.

2. Legal basis

3. Expert insights

Insight one: the metrology track leaves visible traces inside the registration file. Two details of Resolution No. 738 confirm the interweaving of metrology and registration. First, Class I devices with a metrological purpose do not enjoy the treatment that a clinical effectiveness report is generally not required. Second, metrological devices do not enjoy the sample exemption available to ordinary Class I devices. In other words, once a product is recognized as a metrological Class I device, both its evidence burden and its sample burden align with those of a higher class. Misclassifying a measuring product as an ordinary Class I device therefore produces two separate deficiencies instead of one.

Insight two: type approval and metrological certification apply to different scenarios. Under the Law on Metrology, measuring instruments of a specific type produced in series go through state testing (type approval) and are entered in the state register of measuring instruments, while instruments imported as single units or outside serial production go through metrological certification. The former addresses series products, the latter individual large-scale equipment. Companies should choose according to the supply model: declaring a single large installation under the series route creates unnecessary factory audit requirements, while declaring a series product under the single-unit route cannot accommodate successive deliveries.

Insight three: ISO:13485 has been upgraded from a registration support document to a conformity certificate threshold. At the registration stage, the ISO 13485 certificate forms part of the technical documentation; from July 1, 2027, obtaining a conformity certificate requires submitting a conformity certificate meeting the national standard ISO:13485. This change turns the system certificate from a bonus item into an access threshold, and Presidential Decree No. UP-137 defines four categories of exemptions: medicines and devices for rare diseases, products for the control of especially dangerous infectious diseases, devices not subject to the mandatory conformity certificate, and products following the recognition route or WHO prequalification. Manufacturers should map their portfolio against the four exemptions well before the deadline.

Insight four: with three tracks in parallel, technical documentation can be shared, but reports cannot be exchanged. Circuit diagrams, risk analyses, test plans and similar technical documents can serve all three tracks; but the conformity assessment reports must be issued separately, because the objects of evaluation (device, measuring instrument, quality system) and the judgment criteria differ. Submitting the report of one track as the evidence of another is a frequent cause of rework, and it is avoided by defining at the outset which report answers which requirement.

4. Practical recommendations

1. At the project initiation stage, check every device against a three-track list: whether registration is required, whether the product is a measuring instrument, and whether the ISO:13485 conformity certificate requirement applies.
2. Advance the three procedures in parallel, sharing the same set of technical documents and samples, with reports issued separately.
3. Record the metrological purpose judgment in the product definition statement and keep it consistent with the intended use wording, to avoid re-qualification during review.
4. Choose type approval or metrological certification according to the supply model: series production goes through type approval, single large-scale equipment goes through metrological certification.
5. Plan backward from July 1, 2027 for obtaining the ISO:13485 conformity certificate, after first checking the applicability of the four exemptions.

5. Verification checklist

• □ Every device has completed the three-track check of registration, metrology and conformity assessment
• □ Type approval or metrological certification requirements for measuring instruments have been confirmed and started
• □ The metrological purpose and the intended use wording are consistent and recorded in the product definition statement
• □ Reports of the three tracks have been issued separately, with no report of one track substituting for another
• □ The ISO:13485 conformity certificate plan is scheduled backward from July 1, 2027
• □ The applicability of the four exemptions under Presidential Decree No. UP-137 has been checked item by item

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with metrology approval and conformity assessment planning, contact info@grzanglobal.com.