Iran FDA · structured requirements

🇮🇷 Iran IVD regulatory data

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

2 facts1 dimensions1 official sourceslatest verification 2026-09-15

Changes after registration in Iran

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 a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

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?

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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.

Iran 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 Iran (2 records)

IranNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: IMED's import registration file requires a sales/free-sale certificate in the country of manufacture in addition to CE/FDA/Japan approval. For a device manufactured in China this country-of-manufacture requirement can be met with the NMPA registration certificate or China free-sale documentation, but this is purely documentary evidence and provides no abridged or reliance review.
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: iran
China Classes In Scope: NMPA Class II/III registration certificate (and Class I filing) as country-of-manufacture sales evidence for China-made devices
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Must be accompanied by CE (accepted NB), FDA 510(k)/PMA plus registration, or Japanese approval; the NMPA certificate alone does not support registration
Registration code (IRC) validity limited to the shortest of quality-certificate validity, QMS certificate validity, agency validity or three years
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Source passage: ارائه تاییدیه های معتبر بین المللی CE، FDA و یا تاییدیه ژاپن ... گواهی فروش در کشور سازنده. سابقه فروش در اتحادیه اروپایی، آمریکا و یا ژاپن (برای اقلام کلاس C و D)

IranNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference

Pending verification

Statement: IMED's device registration directive requires imported devices to present valid international approvals from CE (notified bodies of IMED-accepted rank), US FDA (510(k)/PMA plus registration) or Japan, together with a sales certificate in the country of manufacture. The country-of-manufacture scoring table places the USA, Germany and Japan in G1, listed European states, Canada and Australia in G2, South Korea and other European countries in G3, and 'all other countries' in G4 with zero points. China/NMPA is not among the accepted approval authorities or named country groups, so an NMPA certificate carries no reliance value, and devices made in G3/G4 countries face mandatory ISO 13485 evidence (classes A/B) and pre-registration production-line audits (classes C/D).
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: iran
China Classes In Scope: NMPA Class I/II/III; all imported devices (IMED risk classes A-D)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Accepted approvals: CE (NB rank 1-3 only), FDA 510(k)/PMA plus registration, or Japanese approval (Shonin/Ninsho)
Sales history in the EU, USA or Japan required for class C and D
ISO 13485 from a competent body mandatory for class A and B devices manufactured in G3/G4 countries
Production-line audit before registration mandatory for class C and D devices manufactured in G3/G4 countries
Country score: G1 30 / G2 20 / G3 10 / G4 0; G4 = 'other countries'
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Source passage: ارائه تاییدیه های معتبر بین المللی CE، FDA و یا تاییدیه ژاپن. توجه: ارائه تاییدیه CE صرفا از NB های رتبه 1، 2 و یا 3 مورد قبول ... گواهی فروش در کشور سازنده ... امتیاز دهی بر اساس کشور سازنده اصلی G1 30 G2 20 G3 10 G4 0 ... کشورهای G3: کره جنوبی، سایر کشورهای اروپایی؛ کشورهای G4: سایر کشورها ... ارائه گواهی مطابقت با استاندارد ISO13485 از نهاد ذیصلاح برای کلاس A و B که در کشورهای G3 و G4 تولید می شوند، الزامی است. برای تجهیزات و ملزومات کلاس C و D که در کشورهای G3 و G4 تولید می شوند، ممیزی خط تولید قبل از ثبت الزامی

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 0 records

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.

No maintained record.

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 Iran fees →

Jurisdiction Id

iran

Country

Iran

Country Code

IR

Authority

Iran FDA

Low Risk Local

Min: 840000
Max: 840000
Currency: IRR
Per Product: No

High Risk Local

Min: 2820000
Max: 2820000
Currency: IRR
Per Product: No

Details

Id
manufacturing-licence-issuance
Item
Manufacturing licence - issuance
Currency
IRR
Amount Local
2820000
Amount Local Formatted
IRR 2,820,000
Frequency
Per licence
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://gservice.mui.ac.ir/fa/node/1417
Source Title
Iran medical-device manufacturing licence issuance fee (service desk)
Verified On
2026-08-25
Id
manufacturing-licence-renewal
Item
Manufacturing licence - renewal
Currency
IRR
Amount Local
840000
Amount Local Formatted
IRR 840,000
Frequency
Per renewal
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://gservice.mui.ac.ir/fa/node/1418
Source Title
Iran medical-device manufacturing licence renewal fee (service desk)
Verified On
2026-08-25

Notes

Registration fees for goods and source establishment exist in the regulations, but current numeric amounts are not published on an opened official page.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Iran medical-device manufacturing licence issuance fee (service desk)
Url
https://gservice.mui.ac.ir/fa/node/1417
Accessed Date
2026-08-25
Title
Iran medical-device manufacturing licence renewal fee (service desk)
Url
https://gservice.mui.ac.ir/fa/node/1418
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 Iran certifications →

Slug

iran

Market

Iran

Confidence

low

Schemes

Id
manufacturing-license-test-and-qms-evidence
Name
Manufacturing-license test reports and ISO 13485
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Manufacturer Site
Note
The class A/B manufacturing-license dossier requires safety and performance test reports issued by the directorate's cooperating laboratories (آزمایشگاه‌های همکار), an ISO 13485 QMS certificate, and suitable production-environment conditions.
Source Urls
https://gservice.mui.ac.ir/fa/node/1417
Source Binding
reviewed
Id
mandatory-standard-license
Name
Mandatory-standard licence at renewal
Category
Product Specific Conformity
Status
Mandatory If Feature
Object
Product Covered By Mandatory Standard
Note
A valid mandatory-standard licence (پروانه استاندارد اجباری) from the national standards body is required at licence renewal for products covered by mandatory standards.
Source Urls
https://gservice.mui.ac.ir/fa/node/1418
Source Binding
candidate

Official Sources

Authority
Iran FDA (MUI)
Topic
manufacturing-license documents — cooperating-laboratory test reports and ISO 13485
Url
https://gservice.mui.ac.ir/fa/node/1417
Authority
Iran FDA (MUI)
Topic
license renewal — mandatory-standard license validity
Url
https://gservice.mui.ac.ir/fa/node/1418

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