Pure Global AI
Pharmaceutical Safety Center · structured requirements

🇺🇿 Uzbekistan IVD regulatory data

Explore the IVD requirements currently available for Uzbekistan, organized by topic and linked to official sources.

3 facts1 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration in Uzbekistan

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Uzbekistan approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Uzbekistan (7 records)

Prior approval / evidence record

NMPA-Uzbekistan Pharmaceutical Safety Center MoU (2025): no recognition effect

reliance.china-nmpa-bilateral-programme
Pending verification
Statement

On 27 June 2025 NMPA Commissioner Li Li and Alisher Temirov, Director of the Pharmaceutical Safety Center of the Uzbekistan Ministry of Health, signed in Beijing the 'Memorandum of Understanding between the NMPA of the PRC and the Pharmaceutical Safety Center of the Ministry of Health of the Republic of Uzbekistan on regulatory cooperation for drugs and medical devices'. The MoU establishes cooperation and exchange; it does not add NMPA to Uzbekistan's recognition list.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

uzbekistan

China Classes In Scope

Not class-specific; regulatory-cooperation MoU (drugs and medical devices)

Edge Type

Cooperation Mou

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Cooperation/exchange instrument; no mutual recognition of registrations
  • Resolution 738 adopted five months later (24.11.2025) still omits NMPA from the recognition list
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2025-06-27

Source passage: 6月27日,国家药监局局长李利在京会见乌兹别克斯坦卫生部药品安全中心主任阿利舍尔•特米罗夫一行,双方就进一步加强中乌在药品监管领域的交流合作进行了深入务实交流,并签署《中华人民共和国国家药品监督管理局与乌兹别克斯坦共和国卫生部药品安全中心关于药品和医疗器械监管合作谅解备忘录》。

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the FDA dossier is reused but the Annex-1 periods are unchanged.

Timeline Savings

None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence
Pending verification
Statement

The general-route dossier table requires, for every class, a certificate of registration of the device in the manufacturer's country or a document confirming registration (free-sale certificate, export certificate with state-language translation), or a copy of a document confirming registration in other countries. A China NMPA registration certificate or NMPA-based export certificate satisfies this item; the device still undergoes full expertise (60-120 working days by class).

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

uzbekistan

China Classes In Scope

All classes (I, IIa, IIb, III) under the general registration route

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Required (+) for classes I, IIa, IIb, III
  • Foreign official documents must be apostilled or consular-legalised unless verifiable through the issuing regulator's open registers
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2026-02-26

Source passage: 5. Тиббий жиҳознинг ишлаб чиқарувчи давлатида рўйхатдан ўтказилганлик ҳақида гувоҳнома ёки рўйхатдан ўтказилганлигини тасдиқловчи ҳужжат (эркин реализация учун сертификат, экспорт сертификати (давлат тилига таржимаси билан) ёки бошқа давлатларда рўйхатдан ўтганлигини тасдиқловчи ҳужжатнинг нусхаси. + + + +

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference
Pending verification
Statement

Under Cabinet of Ministers Resolution No. 738, medical devices are registered by the recognition route only if registered by the US FDA, EU bodies authorised to issue CE certificates, the EMA, Japan's PMDA, Korea's MFDS or the UK MHRA. China's NMPA is not on the list, so a China NMPA certificate does not open the 15-working-day recognition route and the device follows the general (full) registration procedure.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

uzbekistan

China Classes In Scope

All classes (recognition route)

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Exhaustive list: FDA (USA); CE-certifying bodies (EU); EMA (EU); PMDA (Japan); MFDS (Republic of Korea); MHRA (United Kingdom)
  • Recognition route benefits (no samples, no local tests, 15 working days) are unavailable to NMPA-only devices
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2026-02-26

Source passage: Бунда қуйидаги хорижий ташкилотлар томонидан рўйхатдан ўтказилган тиббий жиҳозлар тан олиш йўли билан давлат рўйхатидан ўтказилади: Озиқ-овқат ва дори воситалари сифати назорати бошқармаси (FDA), АҚШ; Европа мувофиқлиги (СЕ) сертификатини беришга ваколатли органлар, Европа Иттифоқи; Европа дори воситалари агентлиги (EMA), Европа Иттифоқи; Фармацевтика ва тиббий буюмлар агентлиги (PMDA), Япония; Озиқ-овқат ва дори воситалари хавфсизлиги вазирлиги (MFDS), Корея Республикаси; Дори воситалари ва тиббий буюмлар назорати агентлиги (MHRA), Буюк Британия.

UzbekistanSource authority not specified

Prior approval / evidence record

Recognition route (device already registered in a reference jurisdiction)

Authority

Recognition route (device already registered in a reference jurisdiction)

Accepted

Yes

Benefit

Cabinet of Ministers Resolution No. 738 decides recognition applications in 15 working days against the ordinary Annex-1 periods of 60, 90 and 120 working days

Timeline Savings

15 working days instead of 60 to 120

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

UzbekistanEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority

CE Mark (EU MDR)

Accepted

Yes

Benefit

Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the CE dossier is reused but the Annex-1 periods are unchanged.

Timeline Savings

None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Uzbekistan registration →
Country

Uzbekistan

Jurisdiction Id

uzbekistan

Country Code

UZ

Flag

🇺🇿

Regulator

Ministry of Health of the Republic of Uzbekistan

Regulator Abbrev

Pharmaceutical Safety Center

Region

asia-pacific

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) — EU-aligned

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    MoH registration

    Official Timeline
    Min

    60

    Max

    60

    Unit

    working-days

    Realistic Timeline
    Min

    3

    Max

    5

    Unit

    months

    Notes
    • Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 60 working days for Class I
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Uzbekistan CM Resolution 738 Annex 1 — registration review by route and class

    Url

    https://lex.uz/uz/docs/7853907

    Accessed Date

    2026-08-25

  • Id

    class-iia

    Class Name

    Class IIa

    Risk Level

    medium

    Pathway

    MoH registration

    Official Timeline
    Min

    90

    Max

    90

    Unit

    working-days

    Realistic Timeline
    Min

    5

    Max

    7

    Unit

    months

    Notes
    • Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 90 working days for Class IIa
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Uzbekistan CM Resolution 738 Annex 1 — registration review by route and class

    Url

    https://lex.uz/uz/docs/7853907

    Accessed Date

    2026-08-25

  • Id

    class-iib

    Class Name

    Class IIb

    Risk Level

    high

    Pathway

    MoH registration

    Official Timeline
    Min

    120

    Max

    120

    Unit

    working-days

    Realistic Timeline
    Min

    7

    Max

    10

    Unit

    months

    Notes
    • Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 120 working days for Class IIb/III
    Clinical Trial Required

    No

    Local Testing Required

    Yes

    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Uzbekistan CM Resolution 738 Annex 1 — registration review by route and class

    Url

    https://lex.uz/uz/docs/7853907

    Accessed Date

    2026-08-25

  • Id

    class-iii

    Class Name

    Class III

    Risk Level

    highest

    Pathway

    MoH registration

    Official Timeline
    Min

    120

    Max

    120

    Unit

    working-days

    Realistic Timeline
    Min

    8

    Max

    12

    Unit

    months

    Notes
    • Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 120 working days for Class IIb/III
    Clinical Trial Required

    Yes

    Local Testing Required

    Yes

    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    Uzbekistan CM Resolution 738 Annex 1 — registration review by route and class

    Url

    https://lex.uz/uz/docs/7853907

    Accessed Date

    2026-08-25

Key Requirements
  • Local Authorized Representative required for foreign manufacturers
  • Recognition route: decisions within 15 working days where the device is registered in a reference jurisdiction
  • Epidemic-need import authorisation: 30 working days; WHO-prequalified devices: 60 working days
  • Annex-1 staged breakdown: application 1 wd, expertise scheduling 15 wd, expertise 30-90 wd by class, decision 10 wd, certificate 5 wd; excluded categories and changes up to 50% of the dossier follow separate tracks
Prior Approvals
  • Authority

    CE Mark (EU MDR)

    Accepted

    Yes

    Benefit

    Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the CE dossier is reused but the Annex-1 periods are unchanged.

    Timeline Savings

    None published

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the FDA dossier is reused but the Annex-1 periods are unchanged.

    Timeline Savings

    None published

  • Authority

    Recognition route (device already registered in a reference jurisdiction)

    Accepted

    Yes

    Benefit

    Cabinet of Ministers Resolution No. 738 decides recognition applications in 15 working days against the ordinary Annex-1 periods of 60, 90 and 120 working days

    Timeline Savings

    15 working days instead of 60 to 120

  • Authority

    WHO prequalification

    Accepted

    Yes

    Benefit

    Separate 60-working-day route under Resolution No. 738

    Timeline Savings

    60 working days instead of 90 or 120 for Class IIa and above

Local Rep Required

Yes

Local Rep Name

Uzbek Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

5 years

Verification Status

official-verified

Official Sources
  • Title

    Uzbekistan CM Resolution 738 Annex 1 — registration review by route and class

    Url

    https://lex.uz/uz/docs/7853907

    Accessed Date

    2026-08-25

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by Pharmaceutical Safety Center. Appoint a Uzbek Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to Pharmaceutical Safety Center including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    Pharmaceutical Safety Center reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. Pharmaceutical Safety Center may issue questions.

    Duration

    60 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, Pharmaceutical Safety Center issues Uzbekistan market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Uzbekistan fees →
Jurisdiction Id

uzbekistan

Country

Uzbekistan

Country Code

UZ

Authority

Center for Pharmaceutical Product Safety (MoH)

Low Risk Local
Min

14832000

Max

14832000

Currency

UZS

Per Product

Yes

High Risk Local
Min

26368000

Max

26368000

Currency

UZS

Per Product

Yes

Details
  • Id

    primary-expertise-class-i

    Item

    Primary (preliminary) expertise of the application - Class I

    Currency

    UZS

    Amount Local

    3296000

    Amount Local Formatted

    UZS 3,296,000 (8 BRV)

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    primary-expertise-class-ii-iii

    Item

    Primary (preliminary) expertise of the application - Classes IIa, IIb, III

    Currency

    UZS

    Amount Local

    4120000

    Amount Local Formatted

    UZS 4,120,000 (10 BRV)

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    specialised-expertise-class-i

    Item

    Specialised expertise and registration decision - Class I (non-sterile, non-measuring, non-invasive)

    Currency

    UZS

    Amount Local

    11536000

    Amount Local Formatted

    UZS 11,536,000 (28 BRV)

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    specialised-expertise-class-i-sterile

    Item

    Specialised expertise - Class I sterile, measuring, or invasive

    Currency

    UZS

    Amount Local

    18540000

    Amount Local Formatted

    UZS 18,540,000 (45 BRV)

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    specialised-expertise-class-i-ivd

    Item

    Specialised expertise - Class I in vitro diagnostic

    Currency

    UZS

    Amount Local

    18128000

    Amount Local Formatted

    UZS 18,128,000 (44 BRV)

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    specialised-expertise-class-iia

    Item

    Specialised expertise - Class IIa (device or IVD)

    Currency

    UZS

    Amount Local

    20600000

    Amount Local Formatted

    UZS 20,600,000 (50 BRV)

    Frequency

    Per device

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    specialised-expertise-class-iib

    Item

    Specialised expertise - Class IIb

    Currency

    UZS

    Amount Local

    21836000

    Amount Local Min

    21424000

    Amount Local Max

    21836000

    Amount Local Formatted

    UZS 21,424,000–21,836,000 (52–53 BRV)

    Frequency

    Per device

    Notes

    Class IIb device 53 BRV; Class IIb in vitro diagnostic 52 BRV.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    specialised-expertise-class-iii

    Item

    Specialised expertise - Class III

    Currency

    UZS

    Amount Local

    22248000

    Amount Local Min

    21836000

    Amount Local Max

    22248000

    Amount Local Formatted

    UZS 21,836,000–22,248,000 (53–54 BRV)

    Frequency

    Per device

    Notes

    Class III device 54 BRV; Class III in vitro diagnostic 53 BRV.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    recognition-specialised-expertise

    Item

    Specialised expertise on the recognition route (FDA, CE, EMA, PMDA, MFDS, MHRA registrations)

    Currency

    UZS

    Amount Local

    15656000

    Amount Local Min

    11536000

    Amount Local Max

    15656000

    Amount Local Formatted

    UZS 11,536,000–15,656,000 (28–38 BRV)

    Frequency

    Per device

    Notes

    Class I 28 BRV, Class IIa 31 BRV, Class IIb 37 BRV, Class III 38 BRV, plus the 8 BRV primary expertise.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

  • Id

    renewal-without-laboratory-tests

    Item

    Validity extension without laboratory testing

    Currency

    UZS

    Amount Local

    14420000

    Amount Local Min

    11536000

    Amount Local Max

    14420000

    Amount Local Formatted

    UZS 11,536,000–14,420,000 (28–35 BRV)

    Frequency

    Per renewal

    Notes

    Class I 28 BRV, Class IIa 31 BRV, Class IIb 34 BRV, Class III 35 BRV.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://kalkulyatsiya.uzpharm-control.uz

    Source Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Source Effective Date

    2026-01-01

    Verified On

    2026-08-25

Notes
  • Uzbek device fees are denominated in the basic calculation value (BRV); the UZS figures use the BRV 412,000 rate published in the authority's own fee calculator, so they move whenever the BRV is revised.
  • A registration costs the primary expertise plus the specialised expertise, so a standard Class I device totals 36 BRV and a Class III device 64 BRV; kits and modification families are priced on a sliding scale that rises with the number of units in the set (up to 104-197 BRV above 1,000 units).
  • Amendments to registration documents cost 30% of the registration fee without laboratory testing and 50% with laboratory testing.
  • Resolution No. 738 of 2025 sets the registration procedure but delegates the amounts to the Ministry of Health, which is why the calculator rather than the resolution carries the tariff.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Center for Pharmaceutical Product Safety (MoH Uzbekistan) official state-registration fee calculator, medical-device tariffs in BRV

    Url

    https://kalkulyatsiya.uzpharm-control.uz

    Effective Date

    2026-01-01

    Accessed Date

    2026-08-25

  • Title

    Uzbekistan Cabinet of Ministers Resolution No. 738 of 24 November 2025, Regulation on state registration of medical devices (fee amounts approved by the Ministry of Health)

    Url

    https://lex.uz/ru/docs/7853907

    Effective Date

    2026-02-26

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Uzbekistan certifications →
Slug

uzbekistan

Market

Uzbekistan

Confidence

low

Schemes
  • Id

    ordinary-route-laboratory-testing

    Name

    Ordinary-route laboratory testing

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    CM Resolution 738 para 17(b) and Annexes 2-3: ordinary-route safety and performance tests (e.g. EMC, electrical safety, biological evaluation) are confirmed in laboratories per national or accepted international standards; IVDs additionally require specificity/sensitivity reports and absence-of-infectious-agents information for biological-material products; stability studies (with state-language translation) apply to shelf-life products; sterile products require sterilization-process validation including packaging validation. Exempt from laboratory tests: WHO-prequalified IVDs, recognition-route devices and components, and class I devices except sterile, measuring and invasive ones.

    Source Urls
    • https://lex.uz/uz/docs/7853907
    Source Binding

    reviewed

Official Sources
  • Authority

    Lex.uz

    Topic

    CM Resolution 738 — para 17(b) laboratory testing and Annex 2-3 test protocols

    Url

    https://lex.uz/uz/docs/7853907

Keep researching this market
View the Uzbekistan resource hub →
DJ Fang
Need to apply Uzbekistan's requirements to a product?
Confirm the current Pharmaceutical Safety Center pathway, evidence, and local-role details for the actual device before filing.
Pricing