Iran Medical Device Registration
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 for medical device registration.
- ISIRI Mandatory Certification: All medical devices require mandatory certification from Institute of Standards and Industrial Research of Iran (ISIRI) for import.
- Import License System: Medical devices need additional import licenses from Iranian Ministry of Health for customs clearance.
- 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 for medical devices.
- ISIRI-led Certification System: Institute of Standards and Industrial Research of Iran (ISIRI) oversees mandatory medical device certification and technical standards.
- Legal Agent Full-chain Responsibility: Iranian authorized agent assumes complete legal responsibility from registration to market supervision for medical devices.
- 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.
- Regional Market Variations: Different Iranian provinces implement medical device 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
- Product Classification Determination
- Technical Documentation Preparation
- Local Agent Appointment
- ISIRI Certification Acquisition
- Iran FDA Registration Submission
- Import License Acquisition
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 medical device registration approval, quality supervision, and market surveillance. The primary medical device regulatory authority in Iran, affiliated with the Ministry of Health.
ISIRI
Institute of Standards and Industrial Research of Iran
Responsible for setting medical device standards and conducting mandatory certification to ensure product quality and safety meet Iranian national standards. All imported medical devices must obtain ISIRI certification.
MOH
Ministry of Health and Medical Education
Responsible for formulating national health policies and medical device 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