Medical Device

Registration Manual
Finished Import - April 2023
Contents
Introduction .................................................................................................................................................. 3
Medical Device and consumable Importing requirements........................................................................... 3
Documentation needed for importing license ............................................................................................. 5
Procedures and methods of importing medical equipment......................................................................... 7
Requested documents for importing medical equipment ........................................................................... 8
Essential definitions ..................................................................................................................................... 8
Appendix 1 - Free Sales Certificate ............................................................................................................. 12
Appendix 2 – Letter of Authorization(LOA) ................................................................................................ 12
Appendix 3 – Letter of Commitment (LOC) ................................................................................................ 13
Appendix 4 – CE/International Organization for Standardization (ISO) ..................................................... 16
Appendix 5 –International sales ................................................................................................................. 16
Appendix 6 – Declaration Letter ................................................................................................................. 17
Appendix 7 – GTIN ...................................................................................................................................... 18
Appendix 8 – Technical Data Sheet............................................................................................................. 18
Appendix 9 – Product Importing Application Form .................................................................................... 19
Appendix 10 – Initial application form for registration of medical device products .................................. 25

Illustrated and arranged by

Hani Sanjarani Pour
Business Development Manager

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Introduction:
Each product that needs to be produced in Iran requires an IRC Code (Iran Registration Code). This IRC is
a unique code for each and every product. In order to obtain the IRC, the products have to be registered
in Iran FDA.

Medical Device and consumable Importing requirements

 Obtaining a license from the General Department of Medical Equipment.

 Obtaining an import and export license from Iran's Ministry of Industry, Mining and Trade at
https://www.ntsw.ir/
 Presenting the documents to the General Department of Medical Equipment.
 The Importing company must be registered in the Iranian official company registration system at
www.irsherkat.ssaa.ir
 Applying for an IRC code, which is a unique identifier for a health-oriented product or a common
identification number for pharmaceutical products, medical and laboratory equipment.
 Appointing a technical supervisor or a technical manager approved by the medical equipment
committee, in order to carry out scientific and legal supervision, on the import process of medical
devices and equipment distribution, by the importer.
 Full compliance of the documents provided with the imported goods.

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Medical device importation approval

4
Documentation needed for importing license

 Registering for an IRC (Iran Registration Code) in the Iranian Ministry of Health (MoH)
 For achieving an IRC code:

- The applicant must sign up for registration on the www.ttac.ir website

- The applicant must register its importing company on the IMED (www.Imed.ir) which is
under the supervision of MOH
- The applicant must place the information of the placed order (PI) from the foreign/parent
company on the Ministry of Industry, Mining and Trade website https://www.ntsw.ir/

 Registering for an IRC (Iran Registration Code) in the Iranian Ministry of Health (MoH)
 Submitting the importing company information on www.import.IMED.ir
 Register your application for the issuance of a license to import medical equipment
 Submitting the foreign/parent company information on www.IMED.ir
 Uploading the following on the Ministry of Industry, Mining and Trade website in order to receive
an 8-digit importation approval code.
 The information of the proforma invoice (PI)
 Submitting the customs information such as shipment, type of contract and number of shipments
and quantities & etc.,
 Submitting the financial and banking information such as total payment, discount, shipping fee,
& etc.,
 Submitting the products by part or groupage

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Medical equipment importing license procedure

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Procedures and methods of importing medical equipment
After the applicant succeeds in obtaining the medical equipment and consumables importing license, the
applicant must go through the following steps in order to be able to import the medical goods to the
country and sell them in the domestic market:

 The first step is to obtain permission from the customs and register the EPL (Electronic Packing
List) declaration
- For uploading the EPL:
- The applicant must have the Final import declaration, bill of lading, copy of commercial
card, license, declaration of currency supply, certificate of origin, purchase invoice,
catalog and brochure, order registration license, insurance policy, operating license,
export license and legal licenses obtained from the Food and Drug Organization and
Department of Medical Devices on order to submit the EPL to the customs.

 In the next step, the applicant must go to coc.isiri.gov.ir to obtain a license from the export and
import system and select one of the standard experts, inspection companies or laboratory users
based on the type of imported goods in order to achieve an import and export license.
 After completing the above steps, the Customs Authentication Department will check the
person's information and if the information and documents provided are approved, a registration
number will be assigned to the applicant.
 In the next step, imported goods are checked for their compliance with presented documents and
declarations, and in case of final approval, the applicant must pay customs duties and customs
clearance fees.
 The clearance document is then issued and the owner of the goods can legally clear her goods
from customs by going through the rest of the procedures.

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Requested documents for importing medical equipment all in one

 Commercial Card
 Mutual agreement/contract between the companies and an approval regarding the registration
of the applicant in the system of the General Department of Medical Equipment
 Product label and product Catalog
 GTIN – Global Trade Item Number
 CE & ISO certificates
 Free Sale Certificate (FSC) / Certificate of Exportation
 Letter of Authorization (LOA)
 COA of product/ Test Report
 Price List
 Art work files (Label, Leaflet, Box)
 Letter of commitment (LOC)
 Market Share / Market History of Product
 Declaration of Conformity (DOC)
 Technical Data Sheet

Essential definitions

CE/International Organization for Standardization (ISO)

CE mean that the manufacturer or importer affirms the goods' conformity with European health, safety,
and environmental protection standards. ISO certification is a seal of approval from a third party body
that a company runs to one of the international standards developed and published by the International
Organization for Standardization (ISO).

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 Free Sale Certificate (FSC)
You can find the Template of Free sale certificate in the Appendix. The authorized body can issue this
certificate for you and you have just to get it signed and approved by the Iran Embassy.

Here are some points which should be noted in Free Sales Certificate:

1. Please make sure that you state the full address and phone number of the manufacturer.

2. The Certificate has to be on a letter head of the authorized body.

3. Please make sure that all pages of the certificate are signed, stamped and bundled together.

4. Please note that you have to submit a Free Sales Certificate per Manufacturing Plant. For
example, if you have part of your product manufactured in a factory in Italy and you have some
products manufactured in France, you will require 2 separate Free Sale Certificates, one for the
manufacturing plant in Italy and one for the manufacturing plant in France.

5. Please make sure that you indicate the Brand name in front of each product in the Product Table.

Letter of Authorization(LOA)
One of the most important step is to submit a true copy of a legalized “LOA”. We need to receive an
authorization letter based on we will be authorized for registration, manufacturing under license,
marketing, distribution and sales your products as your business partner. You can find the sample of LOA
in the Appendix.

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 Registration process in Iran for under license products:
A) Distribution Registration:

The following documents are needed for partnership/distribution registration:

 LOA

 LOC

 CE/ISO

B) Product registration in MoH

require the following documentation (samples are within the appendix):

1. Free Sale Certificate (FSC) / Certificate of Exportation

2. COA of product/ Test Report

3. Price List

4. Art work files (Label, Leaflet, Box)

5. Market Share / Market History of Product

6. Declaration of Conformity (DOC)

7. Catalogue

8. GTIN of Product

9. Technical Data Sheet

COA of product/ Test Report

Certificate of Analysis (COA) is a document that communicates the results of a scientific test done on a
product such as food or drugs. The COA also lists the chemicals used in the product's manufacturing and
testing and is created to ensure all important regulations are met and complied with.

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Declaration of Conformity (DOC)
It is a formal declaration by a manufacturer, or the manufacturer's representative, that the product to
which it applies meets all relevant requirements of all product safety directives applicable to that product.

GTIN of Product
The Global Trade Item Number (GTIN) is a globally unique 14-digit number used to identify trade items,
products, or services.

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APPENDIX 1- Free Sales Certificate
Date:

Name of Licensee: Name of Manufacturer:

Address: Address:

Tel: Tel:

Fax: Fax:

Website: Website:

Free Sales Certificate

This is to certify that the products of company (Please name your company), under …… Brand (Name your
Brand) are freely sold in large scale in …… (Countries names), and are freely and in large scale exported
to other countries.

Products: (List your products in details; please insert a table for this part)

APPENDIX 2- Letter of Authorization(LOA)

[To be printed on Company Letterhead of Product Owner]

Letter of Authorization

[Date]

Subject: Letter of Authorization for [Name of Authorized Representative}

To: ISLAMIC REPUBLIC of IRAN

Ministry of Health and Medical Education National Medical Device Directorate TEHRAN-IRAN

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We, [Name of Product Owner], as the Product Owner, hereby authorize [Name of Authorized
Representative] as the [exclusive I Non-exclusive} representative to prepare and submit applications of the
medical devices to the Ministry of Health and Medical Education of Iran on our behalf.

This authorization shall apply to the following medical devices:

[List containing the name of the medical products]

[Name of Authorized Representative} is authorized by [Name of Product Owner] for the registration,
promotion, sale, distribution, marketing and service and support our products in the territory of Iran.

This authorization commences on the date of signing and is valid for [NO. OF Years/Months]

from [Start Date] for [End Date], If you have any questions, please contact us at [Email Address].

Product Owner Address: [Address],

[Telefax Number], [Email Address]

Authorized Representative Address: [Address],

[Telefax Number}, [Email Address]

[Full Name and Title of Senior Company Official] [Signature]

[Company stamp]

APPENDIX 3 - Letter of Commitment (LOC)

To: ISLAMIC REPUBLIC OF IRAN

MINISTRY OF HEALTH

Treatment assumes & MEDICAL EDUCATION

Medical Equipment Department

TEHRAN-IRAN

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 Commitment Letter

We, Company name, declare of the following items

Company name

Address:

Email： Tel:

This company confirms the technical and professional liability and capability of the representative
company in the fields of technical support, installation, startup training, testing for acceptance and
calibration and operation of equipment and after sales services.

1- This company accepts the responsibility regarding all after sales services and support of the
equipment, equipment related consumable and semi-consumable accessories for the machines

sold to Iran for duration of at least 10 years after installation.

2- This company undertakes to follow all regulations and obligations specified by CE, FDA Procedure
and other competent authorities and regarding the post market phase for medical equipment sold
to IRAN.

3- This company Guarantees the machines sold to Iran at least for 1 year from the date of

Installation.

Note: It is necessary to mention that in special cases, depending upon the type of product, it is possible
to extend this duration upon agreement.

4- In case of transferring our representation in IRAN, this company undertakes to inform the
Department of Medical Equipment of the Ministry of Health, immediately and in the form of written
documentation, and take the necessary actions towards continuously supporting the previously sold
When it comes to termination of current authorization contract or changing representation, the
new representative company which has been appointed by the company shall enjoy the capability
in providing after sales services in conformity with products under representation (and in
accordance with number of sold products manufactured in Iran until its termination time or

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 changing of current representation). Otherwise Iran Ministry of Health and Medical Education and
Treatment assume its right to prevent new representation activity or registry in IRAN.

Note: Definition of after sales services (corresponding to Medical Equipment by – law, Article 32) is hereby
attached.

5- At the time of termination of authorization Contract or its change, equipment or spare parts (whose
production date is not exceeded more than five years) and consumable items holding authentic
expiration date (At least 40% is remained from the production date up to its expiration date)
available in former representative Company's stock which were sold according to the previous price
to former representatives which shall be taken back or Compensate damages and losses inflicted
upon former representative about the mentioned products.

6- All Current representative obligations and offering after sales services of sold equipment will be
rested with manufacturing company or new representative if the representation changes.

Medical Equipment By- law, Article 32:

After sale services consist to a set of measures and engagements undertaken by local or foreign producer
(or his/her legal representative), after selling medical equipment, and in order to attain desired
performance and respecting safety principles, during the engagement duration

Note- The expected measures include installation, operating, acceptance test performance, Training,
guarantee, spare part supply, partial fixing and over hall, calibration, improvement and upgrade, product
tracing, client request satisfying, modification measures performance and product recall.

Sincerely Yours,

General Manager

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APPENDIX 4- CE/International Organization for Standardization (ISO)

APPENDIX 5- International sales

International [product] sales

Country Year Sales amount(PCS) percentage

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 APPENDIX 6 – Declaration Letter

Manufacturer Letterhead

Reference No.

Issuance Date:

To: Islamic Republic of Iran Ministry of Health and Commerce

Declaration Letter

We, (Manufacturer Name) having office at ......., Tel ......, Fax .........., Email: .........., registered No ….. , hereby
confirm that (supplier name) is authorized to sell our Products to Health Invest Tamin Co. (HITCO)
represented by Mr. Ali Babaie as the CEO, having office at No 56, Alvand Street, Tehran, Iran, Postal
Code: ……., Phone: +98 (21) …… Fax: +98 (21) ….., Email:…… , website: www.hitcoholding.com , Registration
number: …. which is the Exclusive Distributor of our supplier for the following Products with the following
brands in Iran territory.

Product name Brand name Manufacturer name

Dispute Resolution: Any difference, dispute, controversy and/or claim should be settled in accordance with the
Arbitration Rules of the International Chamber of Commerce in Paris/ France

Termination: It will be after the expiry of LOA.

This agency agreement is valid for 5 years.

Sincerely yours,

Signature

Name

Title

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APPENDIX 7 – GTIN

APPENDIX 8 – Technical Data Sheet

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APPENDIX 9 – Product Importing Application Form

Product Importing Application Form

1-Product Information
Product (Trade) name (as used in the country of origin)

Active Substance (s):

form:

Route of Administration:

Container. closure and administrative device (s):

Pack sizes and strengths used in the country of origin:

Shelf Life period:

Shelf lifer (after first opening container):

Storage conditions :

2- Manufacturer
Marketing Authorization Holder (Name
Address & Country):
Number and Date of the first Marketing
Authorization / Renewal
Manufacturer of Finished Product (Name
Address & Country):

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 License Holder of Finished product
(Name , Address & Country):
Flow – chart indicating the different sites involved in the Manufacturing process.
Packaging & Release of the medicinal product:

Manufacturer of the Active Substance (s) (Name.

Address & Country) :

List the active substance(s) and the excipient (s)

Components Formula IUPAC Function Quantity Unit Reference

3- Hazards identification
Hazard designation

4- First – aid measures

Inhalation
Skin contact
Eye contact
Ingestion

5- Fire – fighting measures

Suitable extinguishing media
Unsuitable extinguishing media
Additional information

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6- Accidental release measures
Personal precautions

Environmental precautions
7- Handling and storage
Information for safe handling

Information about protection against explosions and fires

Further information about storage conditions

8- Exposure controls and personal protection

Components with critical values that require monitoring at the workplace (exposure
limits)

Personal protective equipment

General protective and hygiene measures

Respiratory protection

Hand protection

Eye Protection

Body Protection

9- Physical and chemical properties Image + Reference + COA

Form:
Color:
Odor:

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 Relevant safety date
Boiling point / rang:
Vapor pressure:
Densing:
Solvent – sparation test:
Solubility in water:
PH Value:
Flow time:
Viscosity:

10- Stability and reactivity

Conditions to avoid

Materials to avoid

11- Toxicological information

Toxicological test
LD50/LC50 values that are relevant for classification

12- Ecological information

Details on elimination (Persistence / degradability)

Additional ecological information

Additional ecological data
Specification:
Value / dosage

13- Disposal considerations

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14- Side effect(s):

15- Regulatory information

Classification according to EEC directives
Danger symbol and danger designation

Hazard – determining components of labeling

Risk - Phrases

Safety - Phrases

National regulatory information

Regulation on inflammable liquids

Emission control act

Water pollution classification

16- Other information

Further information
R- phrases of components

This is to certify that the information contained herein is true and correct.
Name and title of responsible official in the company:
Signature of responsible official in the company :
Date and Stamp :
Full Address :

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17- Official Documents
3

a) Free Sale Certificate (FSC) Yes No

b)Good Manufacturing Practice (GMP) Certificate Yes No

c) List of company branches , if any ……….

d) International Certificates ( FDA , CE , …….) Yes No

e) List of export countries …….

f ) Clinical Trial (Study )

Declare abstract:

18 - Sample of original product ,s label .

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 APPENDIX 10 – Initial application form for registration of medical device products
Initial application form for registration of medical device products (Domestic manufacturing,
importing products)
Applicant company name:
Product brand name:
1. Application of the product:
2. Type of request:
Registration and import Registration and production Contract production Undergraduate
production Extension of construction license
Product Specifications:
Complete product formulation (Components) with names and amounts of active ingredients and
Excipients (separately):

Quantity/ Concentration Manufacturer

Active and Excipients CAS no. Function
ml w/w% company/country

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