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Pharmaceutical Safety Center · South & Southeast Asia

Uzbekistan medical device regulatory resources

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5 free resources24/25 topics with recordsAug 2026 fees reviewed

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Structured regulatory requirements

Explore all 44 source-linked facts →

24 of 25 research dimensions currently covered · 11 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
State registration of medical devices and issuance of registration certificates is carried out by the State Institution "Centre for Pharmaceutical Products Safety" («Фармацевтика маҳсулотла…
2025-2026 regime reorganization
Presidential Decree PF 137 of 19.08.2025 consolidated medical products and medical equipment into a single category of "medical devices" (тиббий жиҳозлар), classified into four safety (risk…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Current regulation and transition
Cabinet of Ministers Resolution No. 738 of 24.11.2025 (devices Regulation in Annex 2) entered into force on 26.02.2026 and repeals CM Resolution No. 213 of 23.03.2018; all new applications,…
Primary law requires state registration
Under Article 6 of the Law "On Medicinal Products and Pharmaceutical Activity" (No. 415 I of 25.04.1997, current version), medical purpose products (изделия медицинского назначения) are sub…
2 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
IVD definition
In vitro diagnostic devices («in vitro» ташхис тиббий жиҳозлари) are products used to examine, diagnose, monitor or establish compatibility of samples taken from the human body outside the…
Medical device definition
Medical devices (тиббий жиҳозлар) are instruments, apparatuses, equipment, devices, units and software permitted for use in medical practice for prevention, diagnosis, treatment, rehabilita…
3 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
Safety (potential risk) classes I, IIa, IIb and III (CM Resolution 738, Annex 2, para 4).
Class I, Class IIa, Class IIb, Class III
1 maintained scheme · 1 related fact
Checked 2026-08-25
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D05

Registration pathways

Verified
Registration routes
Devices undergo state registration either by the ordinary procedure (умумий тартиб) or by the recognition route (тан олиш йўли); recognition applies to devices already registered by specifi…
1 source-linked fact
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA-Uzbekistan Pharmaceutical Safety Center MoU (2025): no recognition effect
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…
China NMPA approval: not reference
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 certific…
4 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Applicant and authorized representative
The applicant is the developer, manufacturer, registration certificate holder, or a legal entity acting on their behalf under a power of attorney (ишончнома); where an application is filed…
1 source-linked fact
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Retail regime and circulation prohibitions
From 1 January 2026 the retail licence requirement for medical devices is abolished; retail proceeds by notifying the authorized body. Devices that must be certified may not be retailed wit…
Wholesale licensing
Wholesale of medicines and medical devices may be carried out only by manufacturers and wholesale organizations holding a pharmaceutical activity licence, under Ministry of Health rules; ma…
2 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Registration dossier
The applicant submits: the trilingual application form; registration documents in electronic form confirmed by the applicant's electronic digital signature per Annex 3 (device information i…
Foreign certificate verification and legalization
Submitted foreign certificates and registration certificates are verified for authenticity against the issuing authority's official registers (websites); where verification through open sou…
3 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Submission portal
From 26.02.2026 new state registration applications for medical devices are filed through the Centre's information system «Darmon»; under the Regulation the documents are uploaded individua…
1 source-linked fact
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Labeling and IFU languages
Registration dossier must include labeling and packaging information with color mock ups (13 18 cm) and labeling text in the state (Uzbek) language, and for foreign manufacturers in Russian…
1 source-linked fact
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Inspection procedure order
MoH order (adopted 14.04.2026, registered 25.05.2026 No. 3838, in force 27.08.2026) sets the inspection procedure: document analysis within 15 working days, inspection program within 10 wor…
ISO 13485 certificate and QMS inspection
At registration the manufacturer's production quality system is inspected for conformity with the Uzbek national standard harmonized with ISO 13485; the dossier must include a copy of the c…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Ordinary-route laboratory testing
Electrical safety
1 maintained overlay · 1 related fact
Checked 2026-08-25
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Primary (preliminary) expertise of the application - Class I
UZS 3,296,000 (8 BRV)
Primary (preliminary) expertise of the application - Classes IIa, IIb, III
UZS 4,120,000 (10 BRV)
10 maintained fee lines · 2 related facts
Checked 2026-08-25
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D15

Review clocks

Verified
Class I · MoH registration
60 working days
Class IIa · MoH registration
90 working days
Class IIb · MoH registration
120 working days
4 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Post-expiry sell-off
Devices manufactured while the certificate was valid may undergo quality control, be imported and sold for 180 calendar days after the certificate expires, and used until their shelf life e…
Certificate validity 5 years
The device registration certificate is issued for a validity of five years. Under PF 137, registration certificates previously issued for an indefinite term are also capped at five years fr…
3 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Change applications
Where information in the registration documents changes during the certificate's validity or extension, the applicant must submit a change application through the information system with do…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
State Register
The Centre maintains the State Register of medicines and medical devices permitted in medical practice; it is published on the official websites of the Ministry of Health and the Centre and…
UDI in application and certificate
The trilingual application form and the registration certificate include the device's Unique Device Identification (UDI) and Global Medical Device Nomenclature (GMDN) "if available"; the Re…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical study requirement
Devices are registered based on the positive results of clinical studies (PF 137); the Regulation exempts from clinical studies: class I devices; WHO prequalified IVDs registered in coopera…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Orphan, epidemic and humanitarian import
Import without state registration is allowed for: devices for diagnosing and treating orphan diseases and for especially dangerous and epidemiologically dangerous infections imported by ord…
Temporary-shortage import without registration
Under MoH Order No. 24 (reg. No. 3749, 09.01.2026, in force 12.01.2026), medicines and devices in temporary shortage may be permitted for import and use in medical practice without state re…
3 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market plan and control
The registration dossier must include a list of adverse events and withdrawal report and a plan for collecting and analyzing post market data on the device's safety and efficacy. Devices ex…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Adverse reaction reporting
The applicant must continually submit to the Centre information on adverse effects (ножўя таъсирлар) that become known during use of the device in medical practice, in the procedure establi…
1 source-linked fact
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
Inspection-failure consequences
If an inspected production site is found non conforming with the national ISO 13485 harmonized standard, certificates of devices previously manufactured and registered at that site are susp…
Suspension and cancellation
Suspension, cancellation and termination of the registration certificate follow Articles 32 34 of the Law "On Licensing, Permitting and Notification Procedures"; a single gross violation of…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertising regime
Under Article 16 of the Law "On Medicinal Products and Pharmaceutical Activity", information on medicines and medical purpose products is provided in the procedure established by the Minist…
1 source-linked fact
Checked 2026-08-25
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D25

Submission communications & appeal

Verified
Right to appeal
The applicant has the right to complain, in the established procedure, against refusal of registration and against actions (inaction) of officials of the Centre. Refusal of registration is…
Deficiency response and decision notification
Deficiency notices are sent through the information system with 30 working days to cure acceptance stage deficiencies (failure leads to a refusal decision, after which a new application is…
2 source-linked facts
Checked 2026-08-25
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Center for Pharmaceutical Product Safety (MoH) registration fees in UZS · reviewed 2026-08-25

Fee lineAmountProvenance
Primary (preliminary) expertise of the application - Class IUZS 3,296,000 (8 BRV)Verified
Primary (preliminary) expertise of the application - Classes IIa, IIb, IIIUZS 4,120,000 (10 BRV)Verified
Specialised expertise and registration decision - Class I (non-sterile, non-measuring, non-invasive)UZS 11,536,000 (28 BRV)Verified
Specialised expertise - Class I sterile, measuring, or invasiveUZS 18,540,000 (45 BRV)Verified
6 more fee lines on the full schedule · 10 of 10 rows source-verified

Registration timeline

Full registration timeline →

Ministry of Health of the Republic of Uzbekistan (Pharmaceutical Safety Center) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU-aligned classification

Class / pathwayReview clockPlanning totalProvenance
Class I(MoH registration)60 working days3-5 monthsVerified
Class IIa(MoH registration)90 working days5-7 monthsVerified
Class IIb(MoH registration)120 working days7-10 monthsVerified
Class III(MoH registration)120 working days8-12 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(60 working days)
  5. 5Registration Approval(1-2 weeks)
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