Medical device registration in Uzbekistan
For manufacturers and distributors. We determine the risk class and route, prepare the dossier, manage the expert review at the Center for Pharmaceutical Product Safety and obtain the registration certificate (RC).
Under Cabinet of Ministers Resolution No. 738 of 24 November 2025
Key figures
- 2004the year we entered Uzbekistan’s medical device market
- 15working days — review by recognition
- 60–120working days — standard review, by risk class
- 3–9months from contract to certificate, as a rule of thumb
We know the procedure from the inside — we have been through it as the applicant
In the market since 2004
Medilife Farma supplies medical devices in Uzbekistan and has registered devices as the applicant itself.
Working under Resolution No. 738
The new registration rules: standard route, recognition of foreign approvals, renewal and amendments.
One window
Dossier, submission, answers to the Centre’s questions and payment of the Centre’s fee on your behalf — with no mark-up on the fee.
Transparent pricing
Our fees are published and the Centre’s fee follows its fee schedule. The final price is fixed in the Specification to the contract.
Confidentiality
Only the Consult team sees your enquiry. Documents are exchanged via a secure link, not through the website.
What we do
Prices are per device (one registration certificate). The Centre’s fee is paid separately, against its invoice.
Registration, standard route
For devices without a recognised foreign approval. Review takes 60–120 working days depending on the class; laboratory testing is included in that time.
5,400 USD · 4,850 EUR · 64,300,000 UZS
per device
Registration by recognition
If the device holds an FDA, CE (EU notified body), EMA, PMDA, MFDS or MHRA approval — or, for IVDs, WHO prequalification. Review takes 15 working days, 60 with WHO prequalification.
3,600 USD · 3,200 EUR · 42,900,000 UZS
per device
Additional variant
Each additional variant of a device — size, version, configuration — within the same registration certificate.
360 USD · 320 EUR · 4,300,000 UZS
per variant beyond the first
Certificate renewal
A registration certificate is valid for 5 years; renewal can be filed 9 months before it expires. The Centre’s fee depends on how the certificate was obtained: by the standard route — with or without laboratory testing; by recognition — at recognition rates.
On request
Centre’s fee — see the calculator
Amendments to a certificate
Centre’s fee: 30 % of the specialised review fee for registering this device by the standard route (including variants and surcharges), 50 % with laboratory testing. Review takes no more than half of the registration term.
On request
Centre’s fee — see the calculator
We pay the Centre’s fee on your behalf: a separate invoice with a copy of the Centre’s invoice, transferred to the Centre within 3 working days, with no mark-up.
Not a public offer. The price is fixed in the Specification to the contract. Prices include VAT where the services are subject to VAT in Uzbekistan. Payment: 50 % on signing the contract, 50 % on receipt of the certificate.
How registration works
From the first enquiry to the State Register entry. You get a progress report every 2 weeks.
- 1
Free assessment
Tell us about the devices and their approvals. Within 3 working days we reply with the risk class, route, cost and timeline.
- 2
Contract and prepayment
The price is fixed in the Specification to the contract. 50 % is paid on signing.
- 3
Document review
Up to 10 working days after prepayment: we check the set and tell you what is missing.
- 4
Dossier and submission
Up to 20 working days from receipt of the full package: we compile the dossier, translate the IFU and labelling into Uzbek and submit to the Centre.
- 5
Expert review
We manage the review, answer the Centre’s questions and pay the fee on your behalf.
- 6
Certificate and State Register
We obtain the certificate and check the State Register entry. The remaining 50 % is due on receipt of the certificate.
Review timelines
working days, clause 14 of Resolution No. 738
| Route | Working days |
|---|---|
| Standard route, class I | 60 |
| Standard route, class IIa | 90 |
| Standard route, class IIb | 120 |
| Standard route, class III | 120 |
| By recognition | 15 |
| IVD with WHO prequalification | 60 |
| Amendments | no more than 50 % of the registration term |
On the standard route, laboratory testing is included in the review time.
Not counted in the review time
- correcting the application — up to 30 working days
- the foreign regulator’s response
- answers to the Centre’s questions — up to 60 working days
- clinical investigations
- manufacturing site inspection
Our own timelines: document review — up to 10 working days after prepayment; dossier preparation and submission — up to 20 working days from receipt of the full package. Overall, from contract to certificate: 3–9 months.
How much will registering your devices cost?
The calculator estimates our fee, the Centre’s fee by risk class and number of variants, the review time and what to plan for. Two minutes, no sign-up.
What the price includes — and what it doesn’t
Included
- Risk class and route determination
- Review of the manufacturer’s documents
- Preparation of the registration dossier
- Submission of the application to the Centre
- Managing the expert review and answering questions
- Translation of the IFU and labelling into Uzbek
- Obtaining the certificate and checking the State Register entry
- Progress report every 2 weeks
Not included
- Testing and inspections, where billed separately
- Clinical investigations
- Samples and their delivery
- Notarisation
- Apostille and legalisation
- Translation of the manufacturer’s documents (other than the IFU and labelling)
The Centre’s fee is separate — paid against the Centre’s invoice, with no mark-up from us.
Frequently asked questions
Free preliminary assessment
Describe your devices — within 3 working days we reply with the risk class, route, cost and timeline.
Contact us directly