Iraq medical device regulatory resources

Competent authority

Federal Iraq: Ministry of Health (MOH); its Technical Affairs Directorate (دائرة الأمور الفنية) houses the Registration Department (قسم التسجيل — companies, preparations, scientific offices…

Medical Devices Management Department duties

The Medical Devices Management Department (قسم إدارة الأجهزة الطبية) within MOH Technical Affairs Directorate provides technical specifications and consulting and follows up medical devices…

KIMADIA founding laws

KIMADIA is governed by the Public Companies Law No. 22 of 1997 (as amended) and its Rules of Procedure No. 1 of 1999.

COSQC legal basis

COSQC's legal basis is Law No. 54 of 1979 (amended) covering standards, metrology and quality control; its metrology department also applies the Weights and Measures Branding Law No. 42 of…

Procurement definition of Registration Certificate

The MOP standard bidding document for medical equipment defines 'Registration Certificate' as the certificate of registration (or other documents in lieu) establishing that the medical appl…

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Procurement device-registration default rule

Under the MOP standard bidding document (ITB 7.4): unless the Bid Data Sheet stipulates otherwise, the medical appliances to be supplied under the contract must be registered with the compe…

Contract effectiveness tied to registration

If the successful bidder's medical appliances are not registered in Iraq at the time of contract signing, the contract becomes effective only on the date the Certificate of Registration is…

Regulatory Authority manufacturing licence accepted

Under the MOP standard bidding document sample clause, bidders who are not primary manufacturers must evidence that their product conforms to the primary manufacturer's quality standards an…

Scientific office / authorized person

For pharmaceutical company and manufacturing site registration with MOH, the manufacturer's authorization must be issued in the name of the scientific office or the authorized person inside…

KRG device import license documents

The KRG import license for medical devices and materials (issued by KMCA) requires a certified certificate of origin, a packing list, the purchase invoice, and a copy of the packaging artwo…

Radioactive-source import chain

Companies and scientific offices importing radioactive sources must first obtain an import authorization for radioactive sources from the National Authority for Nuclear, Radiological, Chemi…

Procurement delivery documents

For goods supplied from outside Iraq under the MOP standard contract, the supplier must deliver with the shipment: signed and stamped invoice; transport document to final destination; packi…

Pharma site registration documents

Pharmaceutical company and manufacturing site registration files with MOH include, among other documents, a GMP certificate, a manufacturing licence, a Site Master File and a boycott declar…

Scientific office information form

Scientific offices must complete the 'scientific offices information accreditation form' (نموذج اعتماد معلومات المكاتب العلمية) so that data is collected and migrated into the Registration…

KRG KMCA e-request portal

KRG device import license applications are submitted online via erequest.kmcakrg.org (the type of materials is selected in the request); after electronic approval, fees are paid at the KMCA…

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No source-verified answer is published for this dimension yet.

COSQC import inspection and pre-shipment inspection

Import CoC / PVoC

Radioactive-source authorization

Radiation

KRG device permit application form

IQD 1,000

Temporary import permit

IQD 20,000

Laboratory devices, materials and supplies (الاجهزة والمواد والمستلزمات المختبرية) — all classes · MoH Technical Affairs evaluation via the UR national services portal

10 working days

No source-verified answer is published for this dimension yet.

No source-verified answer is published for this dimension yet.

No source-verified answer is published for this dimension yet.

No source-verified answer is published for this dimension yet.

No source-verified answer is published for this dimension yet.

Procurement maintenance and spares obligations

Under the MOP standard contract, supplier obligations include installation, demonstration and on site training at end user sites (priced in the schedule), keeping sufficient stock of requir…

MOH device database and performance follow-up

The MOH Medical Devices Management Department's follow up duties include maintaining a detailed statistical database on the numbers of medical devices in MOH facilities and working to test…

No source-verified answer is published for this dimension yet.

COSQC market surveillance

COSQC's remit includes limiting the inflow of low quality goods by inspecting imported goods and monitoring the quality of local products (market surveillance under Law 54/1979).

No source-verified answer is published for this dimension yet.

No source-verified answer is published for this dimension yet.