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…

COSQC role

The Central Organization for Standardization and Quality Control (COSQC, الجهاز المركزي للتقييس والسيطرة النوعية), established by Law No. 54 of 1979 (amended), is Iraq's central body for me…

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…

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.

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…

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

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…

MOH Registration Department scope

The Registration Department (قسم التسجيل) within MOH Technical Affairs Directorate handles registration of companies and (drug) preparations and accreditation of scientific offices, with th…

KIMADIA 2023 dialysis tenders: specified FDA/CE evidence, not a national registration rule

statement: KIMADIA tenders 55/2023/84 and 55/2023/85 for the national hemodialysis project specify FDA/CE quality evidence for the covered equipment. This dated tender document does not est…

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…

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…

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…

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…

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…

Marking and documentation on packages of procured medical appliances are fixed by the supply contract, not by a standing national label rule

Under Iraq's Ministry of Planning standard bidding document for the purchase of medical appliances, the supplier's marking and documentation duties on the goods are set by the contract itse…

The purchaser has the right to inspect and test medical appliances against the contract specifications

Iraq's standard bidding document for medical appliances gives the Purchaser or its representative the right to inspect and/or to test the medical appliances to confirm their conformity to t…

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.

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…

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…

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.

An unsuccessful bidder may demand in writing the reasons for the award and appeal under the government-contracts instructions

For a medical appliance supply contract awarded in Iraq, the Contracting Entity must respond immediately and in writing to any bidder who submits an inquiry to the contracting authority abo…