Iran Product Registration & Certification
Important Notes
- Mandatory Persian Language Requirements: All technical documents and labels must be in Persian requiring translation and notarization by Iranian authorized agencies
- Legal Agent System: Must appoint Iranian-based authorized agent with qualifications recognized by Ministry of Health
- ISIRI Mandatory Certification: All products require mandatory certification from Institute of Standards and Industrial Research of Iran (ISIRI) for import
- Import License System: Medical devices and health products need additional import licenses from Iranian Ministry of Health for customs clearance
- Halal Certification Requirements: Products containing animal-derived ingredients require Islamic Halal certification complying with Sharia law
- Country of Origin Documentation: Must provide free sale certificates and certificates of origin authenticated by Iranian embassies/consulates in Persian
- International Environment Impact: Must consider international sanctions effects on banking payments, logistics, and document authentication processes
- Registration Validity Management: Registration certificates typically valid 5 years requiring renewal application 6 months in advance with possible stricter requirements
Iran Specific Requirements
- Strict Persian Single-language System: Implements strict Persian labeling requiring complete Persian-language technical information and labeling
- ISIRI-led Certification System: Institute of Standards and Industrial Research of Iran (ISIRI) oversees mandatory product certification and technical standards
- Legal Agent Full-chain Responsibility: Iranian authorized agent assumes complete legal responsibility from registration to market supervision
- Halal Certification Specific Requirements: Implements Halal certification for animal-containing products reflecting Islamic Republic characteristics
- Complex Import Licensing Process: Medical devices require multiple permits including ISIRI certification, import licenses, and special customs permits
- International Environment Adaptability: Regulatory processes must adapt to international sanctions requiring special arrangements for payments and logistics
- Traditional & Modern Medicine Integration: Maintains special regulatory framework for Iranian traditional medicine (Yunani Tibb) combining traditional wisdom and modern science
- Regional Market Variations: Different Iranian provinces implement regulatory requirements differently requiring region-specific strategies
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Classification based on risk levels (Class I, II, III)
- Technical documentation and test reports (Persian)
- Quality Management System certificate (ISO 13485)
- Persian labeling and instructions
- Free Sale Certificate (CFS) and Certificate of Origin
- ISIRI Mandatory Certification
- Import License
Main Process
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Registration Timeline
8-18 months
Official Fees
IRR 300,000,000 - 1,200,000,000
Service Fees
US$ 18,000 - 55,000
Regulatory System Overview
Iran FDA
Iran Food and Drug Administration
Responsible for registration approval, quality supervision, and market surveillance of medical devices, cosmetics, and health products; the primary regulatory authority in Iran, affiliated with Ministry of Health
ISIRI
Institute of Standards and Industrial Research of Iran
Responsible for setting product standards and conducting mandatory certification to ensure product quality and safety meet Iranian national standards; all imported products must obtain ISIRI certification
MOH
Ministry of Health and Medical Education
Responsible for formulating national health policies and regulatory framework, supervising FDA operations, and issuing final import licenses
Medical Devices Registration Process
Product Classification
Determine risk level according to Iran medical device classification rules (Class I-III)
Technical Documentation
Prepare complete technical documentation, test reports, clinical data in Persian
Local Agent Appointment
Appoint authorized agent in Iran (mandatory requirement)
ISIRI Certification
Obtain mandatory quality certification from Institute of Standards and Industrial Research of Iran
FDA Registration
Submit medical device registration application to Iran FDA and pay official fees
Import License
Obtain import license from Ministry of Health
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration Certificate
- Ingredient safety assessment report (Persian)
- Persian labeling and packaging requirements
- Good Manufacturing Practice (GMP) certificate
- Compliance with Iran cosmetic regulations list
- ISIRI Quality Certification
- Halal Certification (if applicable)
Main Process
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Registration Timeline
6-12 months
Official Fees
IRR 100,000,000 - 500,000,000
Service Fees
US$ 9,500 - 25,000
Regulatory System Overview
Iran FDA
Iran Food and Drug Administration
Responsible for registration approval, quality supervision, and market surveillance of medical devices, cosmetics, and health products; the primary regulatory authority in Iran, affiliated with Ministry of Health
ISIRI
Institute of Standards and Industrial Research of Iran
Responsible for setting product standards and conducting mandatory certification to ensure product quality and safety meet Iranian national standards; all imported products must obtain ISIRI certification
MOH
Ministry of Health and Medical Education
Responsible for formulating national health policies and regulatory framework, supervising FDA operations, and issuing final import licenses
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Iran cosmetic regulations permitted list
Safety Assessment
Prepare complete product safety assessment report (must be in Persian)
ISIRI Certification
Obtain product quality certification from ISIRI
FDA Registration
Submit cosmetic registration application and documents to Iran FDA
Label Compliance
Ensure labels fully comply with Iran Persian language labeling regulations
Halal Certification
Obtain Halal certification if product contains animal-derived ingredients
Health Products Registration
Regulatory Requirements
- Health Product Registration Certificate
- Ingredient safety and efficacy evidence
- Persian labeling requirements
- Good Manufacturing Practice (GMP) certificate
- Compliance with Iran food and health product regulations
- ISIRI Mandatory Certification
- Halal Certification (if applicable)
Main Process
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Registration Timeline
7-15 months
Official Fees
IRR 150,000,000 - 600,000,000
Service Fees
US$ 12,000 - 35,000
Regulatory System Overview
Iran FDA
Iran Food and Drug Administration
Responsible for registration approval, quality supervision, and market surveillance of medical devices, cosmetics, and health products; the primary regulatory authority in Iran, affiliated with Ministry of Health
ISIRI
Institute of Standards and Industrial Research of Iran
Responsible for setting product standards and conducting mandatory certification to ensure product quality and safety meet Iranian national standards; all imported products must obtain ISIRI certification
MOH
Ministry of Health and Medical Education
Responsible for formulating national health policies and regulatory framework, supervising FDA operations, and issuing final import licenses
Health Products Registration Process
Product Classification
Determine if product is general food, health product, or traditional medicine
Technical Documentation
Prepare ingredient analysis, safety evidence, efficacy proof in Persian
ISIRI Certification
Obtain mandatory product certification from ISIRI
FDA Registration
Submit health product registration application to Iran FDA
Label Review
Ensure labels comply with Iran food and health product labeling requirements
Halal Certification
Obtain Halal certification if product contains animal-derived ingredients