Navigating Medical Device Registration with Iraq’s Regulatory Authority: KIMADIA Guidelines and Requirements
Regulatory Authority
State Company for Marketing Drugs and Medical Appliances (KIMADIA)
“Kimadia” refers to the Iraqi State Company for Marketing Drugs and Medical Appliances. It is a governmental organization responsible for procuring and distributing pharmaceuticals and medical supplies within Iraq, including through tenders and procurement processes.
When “Kimadia” issues tenders for medical devices, they may require that legal manufacturers and manufacturing sites be registered through a country-specific form. This registration process ensures that the manufacturers and manufacturing sites comply with Iraqi regulations and standards for medical devices.
Ministry Of Health
Classification of Medical Devices
Class A, B, C, D
KIMADIA Guidelines and Registration Requirements
1. Registration of the foreign supplier at the Ministry of Health (MOH) Registration Board.
2. For each consignment to the private sector, documents must be presented before an import license will be issued by the MOH.
3. For sales under The State Company for Marketing Drugs and Medical Appliances (KIMADIA) tenders, a complete set of documents must be presented before an import license will be issued by the MOH.
Documents Required for Iraq Medical Device Registration
1. Company registration form to be filled in one copy Signed and stamped by the person responsible on the establishment.
2. Quality assurance certificate such as ISO 9001, 9002 or equivalent.
3. Manufacturer registration certificate in the country of origin officially legalized.
4. Spread data sheet of the company products (catalogue)
5. Certification letter regarding the boycott with Israel.
6. Company registration fee $ 1000.
7. Manufacturer registration certificate in the C.O.O, and the LoA.
8. Certificates of Free Sale (CFSs) are required for: general medical devices; active implantable medical devices and in vitro diagnostic medical devices as well as a mixture of the above devices.
License Validity
Registrations need to be renewed after five years, in most cases.
Additional Comments
1. All submitted documents need to be properly legalized and stamped, as per Iraqi law.
2. For products originating from certain countries, and in certain cases, the Ministry of Health will require the applying party to pay for Ministry inspectors to visit and inspect production facilities.
3. Separate import licenses are needed for each shipment, obtained through the MOH.
4. For tenders through KIMADIA, a specific registration process might apply.
Who should make this Communication?
1. Manufacturer
2. Authorized Representative
When to make this Communication?
Before placing a medical device into the market.
How OMC Medical can assist you with the process?
Act as your Authorized representative
Why Choose Us?
1. Working towards client satisfaction
2. Cost effective solutions
3. Project completion before deadline
4. Quality Regulatory affairs solutions
