Uzbekistan Medical Device Regulatory Calendar 2025–2028: Key Milestones and Planning

1. Key takeaways

Medical device regulation in Uzbekistan underwent a concentrated reconstruction between August 2025 and July 2027, with 9 key milestones in total: from Presidential Decree No. UP-137 on 2025-08-19 to the mandatory requirement for an ISO:13485 conformity certificate on 2027-07-01. A company compliance calendar should be planned backward from these 9 milestones as a single program, rather than reacting passively to each product event as it arrives. Companies that map the milestones once, assign owners to each of them, and review progress on a fixed schedule can absorb the reform with one coordinated effort, while companies that treat each milestone as a separate surprise will spend significantly more on rework, urgent document preparation, and last-minute representative coordination. The milestones are fixed by legal acts, so they do not move with project schedules; only the preparation effort of the company is adjustable, and a backward plan from the latest deadline, 2027-07-01, is the most reliable way to size the total workload.

2. Legal basis

3. Expert insights

Insight 1: The 9 milestones fall into three groups by nature. The first group covers the registration system (2025-08-19, 2025-11-24, 2026-01-01, 2026-02-26, 2026-10-08), the second group covers traceability and circulation (2025-10-06, 2026-03-01), and the third group covers system and certificate thresholds (2027-01-01, 2027-07-01). The three groups correspond to three distinct management objects: product access, circulation compliance, and system maintenance. Assigning each group to a different internal owner prevents any single milestone from being managed by nobody. Grouping also simplifies reporting to management, because progress can be summarized in three lines instead of nine dates scattered across departments.

Insight 2: There is a buffer of about 3 months between adoption of an instrument and its entry into force. Resolution No. 738 was adopted on November 24, 2025 and entered into force on February 26, 2026, an interval of roughly 3 months. This buffer gives companies and their representatives time to prepare, but it also means that applications submitted during the buffer period may still be processed under the old procedure. The applicable version should therefore be confirmed at project initiation, not assumed. Applicants who start preparing during the buffer period can also align their dossiers with the new rules before submitting, which avoids a resubmission under the changed requirements.

Insight 3: The year 2026 is the densest year for milestones. Within 2026, companies must handle the entry into force of the new regulation (February 26), the full effectiveness of digital labeling (March 1), the binding of code verification to receipt issuance (July 1), and the entry into force of the dossier rules (October 8). The four milestones belong to three different regulatory systems, and they can only be managed coherently through a single annual compliance calendar that consolidates all of them into one view. The four dates also fall in different quarters, which makes a quarterly internal checkpoint a natural control rhythm for the year.

Insight 4: The two milestones of 2027 target medicines and devices respectively. The date 2027-01-01 is the GMP requirement for medicines conformity certificates, while 2027-07-01 is the ISO:13485 requirement for device conformity certificates. Device manufacturers should plan backward from the latter date, but combination products that span both categories must be checked against both deadlines, since a drug-device combination can be pulled into either track depending on its classification. For device manufacturers, the practical difference is a planning window: audits, corrective actions, and certificate issuance each take time, and all of them must fit before the deadline.

4. Practical recommendations

1. Build a 9-milestone compliance calendar and manage it in three groups: registration system, traceability and circulation, and system and certificate thresholds.
2. Complete internal procedure adjustments during the buffer between adoption and entry into force of each instrument, rather than waiting until after the effective date; a version log of internal procedures makes the adjustment auditable.
3. Confirm the implementation status of the four 2026 milestones quarter by quarter (February, March, July, and October), and document each confirmation with evidence rather than only with a status mark.
4. Plan backward from 2027-07-01 for the national ISO:13485 conformity certificate, starting from the audit lead times of the certification body.
5. Review the calendar every six months to confirm whether new amendments or implementing lists have been added.

5. Verification checklist

• □ A 9-milestone compliance calendar has been established and is managed in three groups
• □ The buffer between adoption and entry into force has been used for internal procedure adjustments
• □ The four 2026 milestones (02-26, 03-01, 07-01, 10-08) have been confirmed quarter by quarter
• □ Device manufacturers have planned backward from 2027-07-01 for the national ISO:13485 conformity certificate
• □ Combination products have been checked against both 2027-01-01 and 2027-07-01
• □ A semiannual calendar review mechanism has been established

Regulatory information verified as of October 29, 2026.

GRZAN provides regulatory support to manufacturers, importers, and authorized representatives seeking medical device registration and post-market compliance in Uzbekistan, including dossier preparation, authorized representative arrangements, vigilance setup, and surveillance readiness. For inquiries, contact info@grzanglobal.com.