Does CE Marking or FDA Clearance Replace Registration in Uzbekistan?

Short answer: No. A CE marking or an FDA clearance does not replace state registration in Uzbekistan. A device may only be imported, distributed or used after it is entered in the national State Register of medicines and medical products. However — and this is the useful part — under Resolution No. 738 (24 November 2025, in force 26 February 2026) an eligible foreign approval can qualify your device for a recognition (simplified) route, which can reduce local testing and shorten the timeline. So existing approvals are supporting evidence and an accelerator, not a substitute.

What CE marking and FDA clearance actually do here

Think of your existing approvals in two roles.

As market authorization: no effect. Uzbekistan runs its own registration system. Without a State Register entry, the device is not legally on the Uzbek market, regardless of how many other markets have approved it.

As evidence: significant effect. A valid approval from a recognized regulator can move you onto the recognition route. Reference regulators named in the framework include the US FDA, CE-marked devices under EU notified-body review, EMA, PMDA (Japan), MFDS (South Korea) and MHRA (United Kingdom). On this route, a device already approved by one of these authorities may avoid duplicate local laboratory testing and rely on a streamlined dossier.

The recognition route: what to check before you rely on it

Being CE-marked or FDA-cleared in general is not enough. The recognition route depends on details, so verify each of these:

1. Same configuration. The eligible approval must cover the same device configuration you intend to register — same model, variants and intended use. A CE certificate for a different model or a superseded version may not qualify.
2. Valid and current. The foreign approval must be in force, not expired, withdrawn or under transition.
3. Correct approval type. For CE, this generally means devices under notified-body review; a self-declared low-risk CE class may be treated differently. For FDA, confirm whether your route was 510(k) clearance, PMA approval or another status, and that it maps to your device.
4. Matching legal manufacturer. The manufacturer named on the foreign certificate should match the entity in your Uzbek dossier.
5. Authorized representative in place. Recognition route or not, a foreign manufacturer must appoint an authorized representative with a registered office in Uzbekistan.
6. Labeling and IFU. Instructions and labeling still need to meet Uzbek language and content requirements.

Full route vs. recognition route

• Full (general) registration typically requires complete design and manufacturing documentation, proof of QMS (ISO 13485 or equivalent), clinical evidence proportionate to class and novelty, and may involve local testing. It commonly takes several months.
• Recognition (simplified) route applies when you hold an eligible reference approval for the same configuration. It streamlines dossier requirements and can materially shorten the timeline.

The right route is a factual determination about your certificate and your device — not a general assumption.

What depends on your specific case

• Whether you qualify at all depends on which regulator approved the device and whether the configuration matches.
• How much local testing is waived depends on class, novelty and the completeness of your dossier.
• The timeline depends on route, dossier readiness and any residual local review.
• The device class (IVD, active, implantable, software, equipment) affects both routes.

Typical mistakes to avoid

• Believing CE/FDA "counts as" registration. It does not — the State Register entry is mandatory.
• Assuming automatic eligibility. Holding a CE mark is not the same as holding the right CE certificate for the exact configuration.
• Overlooking certificate scope. Accessories or variants outside the foreign certificate may fall back to the full route.
• Letting the foreign approval lapse mid-process, which can invalidate the recognition basis.
• Skipping the authorized representative, which is required regardless of route.
• Importing on the strength of a CE mark before the Uzbek registration exists.

Official sources

• Resolution of the Cabinet of Ministers No. 738 of 24.11.2025 (in force 26.02.2026) — lex.uz
• State Register of Medicines and Medical Products — uzpharm-control.uz
• SI "Center for Pharmaceutical Products Safety" under the Ministry of Health — uzpharm-control.uz
• National legal database — lex.uz

Always confirm current requirements against the primary sources above or with a qualified local specialist; regulations change.

Related reading

• Medical Device Registration in Uzbekistan: What Foreign Manufacturers Should Prepare Before Starting
• Medical Device Registration in Uzbekistan: Documents, Participants and Typical Workflow

Work with UZ NOW

UZ NOW assesses whether your device qualifies for the recognition route and coordinates the filing through one accountable local lead in Tashkent.

• Service: Medical device registration in Uzbekistan
• Get in touch: Contact UZ NOW

Author: Maxim Korovkin, UZ NOW (Tashkent). Published 15 July 2026 · Updated 15 July 2026.