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ISO 13485:2016 - CE MDR 2017/745 - Direct from Sialkot - Arabic Labelling as Standard

Dental Syringe Supplier Iraq

GERATI Healthcare supplies ISO 13485 certified, CE marked dental aspirating syringes direct from our Sialkot factory to scientific offices, importers and KIMADIA tender suppliers across Iraq and the Kurdistan Region. Factory-direct pricing, Arabic labelling, and ICIGI conformity inspection arranged in Pakistan before shipment. Response within 2 working days.

Ships Baghdad and Erbil 5-8 Days Factory-Direct Pricing ISO 13485:2016 CE MDR 2017/745 Arabic Labelling ICIGI Conformity Support
5-8
Working days Sialkot to Baghdad or Erbil
30-60%
Below European unit cost, same CE mark
65+
Countries GERATI exports to
1972
Manufacturing since, under PHF Group
Quick Answer
GERATI Healthcare is an ISO 13485:2016 certified dental syringe manufacturer in Sialkot, Pakistan, supplying scientific offices, private importers and KIMADIA tender suppliers across Iraq and the Kurdistan Region at factory-direct prices. We ship to Baghdad, Basra and Erbil in 5 to 8 working days with Arabic labelling, Ministry of Health registration documentation, and the ICIGI conformity inspection arranged in Pakistan before departure. Email sales@gerati.com or WhatsApp +92 300 8610614 for samples, pricing, or documentation.
Contents
01 - What We Supply

Dental Syringes Available for Iraq Distribution

Six dental syringe lines, all CE marked under EU MDR 2017/745 and manufactured under ISO 13485:2016. Every line is available in EU thread 1.8ml and American thread 2.2ml, GERATI branded or private label, with Arabic and English labelling as standard.

Standard Aspirating Syringe
Breech-loading with harpoon aspiration. Grade 410 stainless steel or brass and chrome. Standard and petite sizes. The core line for Iraqi private clinics and the highest volume seller into the market.
Non-Aspirating Syringe
T-bar handle, no harpoon, for maxillary infiltrations. The volume line for public hospital and dental college supply, where instrument counts are high and tender pricing is tight.
Safety Aspirating Syringe
Needle shielding mechanism. Increasingly specified by donor-funded health programmes, international NGO procurement, and private hospital groups operating written sharps safety policies.
Self-Aspirating Syringe
Passive diaphragm aspiration, EN ISO 9997:2020 Type 2b, stainless steel, EU thread 1.8ml. Demand concentrated in Baghdad and Erbil specialist practices prioritising ergonomics.
Intraligamentary Syringe
Pistol-grip, 0.2ml per activation, stainless steel with PTFE sleeve. A specialist line for periodontology and oral surgery departments. Lower volume, higher margin.
OEM and Private Label
Your brand laser engraved on the barrel, Arabic and English packaging carrying your scientific office details, and CE documentation structured to sit inside your own Ministry of Health registration file.

Samples are available before any commercial commitment. Most Iraqi partners start with one or two lines, assess the instrument and the documentation, then widen the range once Ministry of Health registration is in place.

02 - Commercial Terms

Pricing, Shipping and ICIGI Conformity for Iraq

What You Need to KnowGERATI Position
Pricing Factory-direct from Sialkot with no intermediary margin. Instruments made to AISI-grade stainless steel specification run 30 to 60 percent below equivalent European-manufactured instruments carrying the same CE certification. Tiered by annual volume and confirmed at quotation.
Minimum order Flexible and set at quotation stage. We accept small trial quantities from new Iraqi partners so you can assess quality and documentation before committing. Commercial tiers apply once volume is established.
Production lead time 3 to 5 weeks from confirmed purchase order and deposit on existing specifications. Arabic artwork adds time to the first run only, not to repeat orders.
Air freight DHL or FedEx from Sialkot to Baghdad, Basra, Erbil or Sulaymaniyah in roughly 5 to 8 working days. The right choice for samples, first orders, and urgent tender deliveries.
Sea freight Karachi to Umm Qasr is a short regional lane, commonly 10 to 18 days, then inland to Baghdad. Substantially lower freight cost per unit and well suited to tender volumes. Overland routing via Trebil or Ibrahim Khalil is also possible depending on your forwarder.
Labelling Arabic and English labelling, packaging and Instructions for Use produced as part of the run, carrying your scientific office name and address. Kurdish-language additions available on request for Kurdistan Region supply.
Response time 2 working days on any qualified enquiry. Complaints investigated and answered within 10 working days under our ISO 13485:2016 corrective action procedure.

ICIGI: the conformity certificate that stops consignments at the border

Since 1 January 2020, Iraq has required a Certificate of Conformity for regulated goods under the ICIGI programme, run by the Central Organization for Standardization and Quality Control. A COSQC-appointed certification body inspects the consignment in the country of export, before it ships, and issues the certificate. Without it, goods face clearance delays, penalties, or return at the importer's cost.

The inspection happens at our end, so we treat it as our job. GERATI already runs pre-shipment conformity inspection in Pakistan for other markets, including the Kenyan PVoC programme, and the ICIGI process follows the same shape: request for certification, assessment against the applicable standards, inspection in the country of origin, then certificate issue before departure. We prepare the invoice, packing list, test reports and conformity documentation the appointed body requires. Tell us Iraq is the destination at purchase order stage and we build the inspection into the production schedule rather than bolting it on afterwards.
Kurdistan Region consignments follow a separate conformity route. Shipments into the Kurdistan Region fall under a Consignment Based Conformity Assessment scheme operated for the region, not the federal ICIGI programme, and a Certificate of Conformity is required for customs clearance there too. If your business covers both Baghdad and Erbil, tell us at quotation stage which entry point each consignment uses, because the certificate is issued against the consignment and the route.

Documentation supplied

Every commercial shipment carries the CE Declaration of Conformity, EN ISO 17664-1 reprocessing Instructions for Use, commercial invoice and packing list. Available on request for Ministry of Health registration: ISO 13485:2016 certificate, quality assurance certification, manufacturer registration certificate from the country of origin prepared for legalisation, product specification sheet and engineering drawings, ISO 14971 risk analysis, steel mill material certificates per batch, Certificate of Origin from the Sialkot Chamber of Commerce and Industry, and a Free Sale Certificate prepared for legalisation and consular stamping.

Start the legalisation early. It is the slowest part of Iraqi market entry. Iraqi law requires submitted documents to be properly legalised and stamped, and that process runs on external timelines nobody controls. We assemble the full manufacturer-side pack and release it at partnership stage rather than waiting for a purchase order, so your scientific office can begin legalisation while commercial terms are still being agreed. Email sales@gerati.com with your company name and we will send it within 2 working days.

Request Samples, Pricing, or the Documentation Pack

Send your company name, scientific office status, specification and estimated annual volume. We respond within 2 working days.

Start Enquiry →
03 - Who We Supply

Which Iraqi Buyers GERATI Supplies

GERATI does not supply individual dental practices. We supply B2B buyers in commercial quantities, and Iraq divides into two channels that are legally, not just commercially, distinct.

Scientific Offices and Private Importers

Iraqi-registered scientific offices in Baghdad, Basra and Erbil supplying private dental clinics, private hospitals and dental colleges.

The only lawful route into the Iraqi private sector
Carry out Ministry of Health registration on the manufacturer's behalf
Import licence needed for each consignment, not once per product
Value exclusivity, so a strong fit for private label
KIMADIA Tender Suppliers

Companies bidding into tenders from KIMADIA, the state company that imports and distributes for all public health facilities in Iraq.

Covers the entire public network including the Kurdistan Region
Tenders are published openly, so the calendar is visible in advance
Practice tends to favour bidders with a local representative
Large committed volumes, heavily price-scored
One structural advantage Iraq has over most tender markets: you can see the calendar. KIMADIA publishes its tenders openly on its own website, which means a prepared supplier can work backwards from a known closing date instead of reacting to an announcement. Combined with the fact that Ministry of Health registration typically stays valid for five years, that rewards getting registered once, properly, and then bidding repeatedly. We release the full documentation pack at partnership stage precisely so you can register ahead of the tender calendar rather than behind it.
04 - Market Context

The Iraqi Market and the Kurdistan Split

Iraq has very limited domestic production of medical equipment and supplies, so nearly all demand is met by imports. For a dental instrument manufacturer that is the whole opportunity: you are not competing against local factories the way you would in Mexico or India, you are competing against other importers on price, documentation and reliability.

Iraq Market and GERATI Supply Context
Sources: US Department of Commerce Iraq Country Commercial Guide, healthcare and medical equipment; Al Tamimi and Company guide to the Iraqi healthcare industry; COSQC ICIGI programme documentation via appointed certification bodies; KIMADIA; KRG Ministry of Health import licensing service
2
Separate conformity regimes to plan for
Federal ICIGI and Kurdistan CBCA
5 yrs
Typical MOH registration validity
Renewal required to stay active
2020
ICIGI conformity in force since January
Pre-shipment inspection, country of origin
Low
Domestic medical equipment production
Import-dependent across most categories
5-8
Working days Sialkot to Baghdad by air
Umm Qasr by sea in 10 to 18 days
2027
GERATI CE certificate valid until June
EC/4802/20 current and available

The feature that shapes everything operationally is that Iraq behaves as two import markets. Federal Iraq clears through Baghdad, Basra, Umm Qasr and Trebil under the ICIGI conformity programme. The Kurdistan Region clears through Erbil, Sulaymaniyah and Ibrahim Khalil under its own consignment conformity scheme, and the KRG Ministry of Health issues its own import permission letters and requires company registration in the region. Confusingly for newcomers, KIMADIA still procures for public facilities in both, so the public channel is unified while the private import channel is not. A distributor covering both needs to plan documentation twice.

That two-track structure is closer to the UAE, where several authorities run parallel registrations, than to Saudi Arabia, where a single national regulator covers the whole Kingdom.

05 - Regulatory

Iraqi Ministry of Health Registration in Brief

You do not need to read this section to start a conversation with us. It is here because Iraq has one legal requirement that has no equivalent anywhere else in our export range, and not knowing about it wastes months. Your scientific office will handle the detail.

Iraq has no standalone medical device agency in the style of the Saudi SFDA or the Kenyan PPB. Registration sits with the Ministry of Health Registration Board, and the state company KIMADIA handles importation and distribution for the public network. Foreign suppliers register with the Ministry, and separate import licences are issued per consignment rather than once per product.

The scientific office requirement, which is the thing most exporters have never heard of. Under Iraq's Pharmaceutical Law No. 40 of 1970 and the accompanying Instructions No. 4 of 1998, medical products may be imported into Iraq only through Iraqi-registered third parties known as scientific offices. For the private sector this is the only lawful route: there is no direct-to-distributor option. The exception is KIMADIA, which has authority to deal directly with foreign manufacturers where it judges that necessary, though in practice it still prefers to work through registered scientific offices. A scientific office can carry out Ministry of Health registration and bid on behalf of the manufacturer it represents, using properly notarised authorisation letters. If a prospective partner in Iraq is not a registered scientific office, ask how they intend to import before anything else is discussed.

The organisations you will deal with

Ministry of Health
Registration Board
Registers foreign suppliers and their products, issues the import licence required for each consignment, and may in certain cases require the applicant to fund a Ministry inspection visit to the production facility.
KIMADIA
State Company for Marketing Drugs and Medical Appliances
Government-owned company under the Ministry of Health responsible for importing and distributing pharmaceuticals and medical appliances for all public health facilities, including those in the Kurdistan Region. Operates through published tenders.
COSQC
Central Organization for Standardization and Quality Control
Runs the ICIGI conformity programme through appointed certification bodies that inspect consignments in the country of export and issue the Certificate of Conformity required for customs clearance.
Where GERATI's certification helps you. Iraqi registration requirements centre on a quality assurance certificate and a legalised manufacturer registration certificate from the country of origin, alongside product documentation. Our ISO 13485:2016 certificate, audited annually by an accredited third-party body, and our CE marking under EU MDR 2017/745, Certificate EC/4802/20, cover the quality and conformity evidence in that file. We also supply the Free Sale Certificate and Certificate of Origin prepared for legalisation.
Two practical cautions. First, the Ministry may require the applying party to pay for Ministry inspectors to visit and inspect production facilities, depending on the product's country of origin and the circumstances. Ask your scientific office to establish early whether this applies to a Pakistani-origin dental instrument, because it affects both budget and timeline. Second, any change to information already provided to the Ministry needs to be updated for the registration to stay active, so tell us before you change packaging, artwork or specification.

Registration validity, legalisation, import licences and Kurdistan requirements are covered in the FAQs below.

06 - FAQs

Frequently Asked Questions

What is the minimum order quantity for dental syringes supplied to Iraq?+
Minimum order quantities are flexible and confirmed at quotation stage based on specification, thread standard and volume. For trial orders from new Iraqi scientific offices and importers evaluating our instruments, we accept smaller quantities so you can assess quality and documentation before committing to a full commercial order. Once volume is established, commercial pricing tiers apply. Send your specification and estimated annual volume to sales@gerati.com and we will confirm the applicable MOQ and pricing within 2 working days.
Do I need a scientific office to import dental instruments into Iraq?+
For the private sector, yes. Under Iraq's Pharmaceutical Law No. 40 of 1970 and Instructions No. 4 of 1998, importing medical products into Iraq must be done through Iraqi-registered third parties known as scientific offices. Where you are trading with the Iraqi private sector, a scientific office is the only lawful route, and there is no direct-to-distributor alternative. The exception is KIMADIA, the state company, which has authority to deal directly with non-Iraqi manufacturers where it deems that necessary, although in practice it still prefers to work through registered scientific offices. A scientific office can also carry out Ministry of Health registration and bid in tenders on behalf of the manufacturer it represents, using properly notarised authorisation letters. If you are evaluating a potential Iraqi partner, confirm their scientific office registration before discussing commercial terms.
What is ICIGI and does GERATI handle the Certificate of Conformity?+
ICIGI is Iraq's pre-inspection, testing and certification programme for goods entering the country, administered by the Central Organization for Standardization and Quality Control through appointed certification bodies, and in force since 1 January 2020. The consignment is assessed and inspected in the country of export, before shipping, and a Certificate of Conformity is issued on successful inspection. That certificate is checked at the Iraqi border, and consignments arriving without a valid one face clearance delays, penalties, or return at the importer's cost. GERATI already operates pre-shipment conformity inspection from Pakistan for other markets, and we prepare the invoice, packing list, test reports and conformity documentation the appointed body requires. Tell us Iraq is the destination when you place the order so the inspection is built into the production schedule.
Are the Kurdistan Region requirements different from federal Iraq?+
Yes, on the import side. Consignments entering the Kurdistan Region fall under a Consignment Based Conformity Assessment scheme operated for the region rather than the federal ICIGI programme, and a Certificate of Conformity is still required for customs clearance. Separately, the KRG Ministry of Health issues its own import permission letters for medical devices entering the Kurdistan Region from outside Iraq, and requires the requesting company to hold a ministerial decision for company registration with the KRG Ministry of Health, along with a notarised certificate of origin and packing list. Confusingly, the public procurement channel is not split in the same way, because KIMADIA procures and distributes for public health facilities across Iraq including the Kurdistan Region. In short, plan the public channel once and the private import channel twice.
How long does Iraqi Ministry of Health registration last and what does it involve?+
Registrations generally need to be renewed after five years. The registration file centres on a company registration form signed and stamped by a responsible person, a quality assurance certificate such as ISO 13485 or equivalent, and a manufacturer registration certificate from the country of origin, officially legalised. All submitted documents must be properly legalised and stamped as Iraqi law requires, and in certain cases and for products from certain countries of origin the Ministry may require the applying party to pay for Ministry inspectors to visit and inspect the production facility. Note also that separate import licences are needed for each shipment rather than once per registered product, and that any change to information already given to the Ministry must be updated for the registration to remain active. Confirm current requirements with your scientific office, since the document list attached to a given KIMADIA tender is the most reliable source.
How long does shipping take from GERATI to Baghdad or Erbil?+
Air freight via DHL or FedEx from Sialkot to Baghdad, Basra, Erbil or Sulaymaniyah takes roughly 5 to 8 working days, which is the right choice for samples, first orders and urgent tender deliveries. Sea freight from Karachi to Umm Qasr is a comparatively short regional lane at around 10 to 18 days, with inland movement to Baghdad from there, and it reduces freight cost per unit substantially on tender volumes. Overland routing through Trebil or, for the Kurdistan Region, Ibrahim Khalil is also possible depending on your forwarder. Production lead time is 3 to 5 weeks from confirmed purchase order and deposit. Build the ICIGI conformity inspection into that schedule rather than treating it as a final step, since it happens in Pakistan before the goods depart.
Can GERATI supply dental syringes for KIMADIA tenders?+
We supply the product and the documentation. KIMADIA is the government-owned company under the Ministry of Health responsible for importing and distributing pharmaceuticals, medical appliances and equipment for all public health facilities in Iraq, including the Kurdistan Region, and it operates through a tender procurement system with tenders advertised publicly. While it is not strictly necessary to have a local agent to participate, KIMADIA practice tends to favour companies with local representatives or those selling through a scientific office, so in practice a scientific office relationship is the sensible route. One genuine advantage over other tender markets is that the calendar is visible: because tenders are published openly, a registered supplier can work backwards from a known closing date. Each tender document also lists the specific documents required, which makes it the most reliable guide to current requirements.
Does GERATI provide Arabic labelling and Instructions for Use?+
Yes. We produce Arabic and English labelling, packaging and reprocessing Instructions for Use as part of the production run rather than as an afterthought applied later, with your scientific office details incorporated into the artwork. We already produce Arabic artwork for our Gulf markets, so this is established capability rather than a new undertaking. Kurdish-language additions are available on request where a partner supplies principally into the Kurdistan Region. Confirm the Arabic text with your scientific office before the print run, since they carry responsibility for the registration file in Iraq, and remember that changing artwork after registration requires the Ministry record to be updated.
Is buying dental syringes from a Pakistani manufacturer reliable?+
Sialkot is one of the world's three primary surgical instrument manufacturing centres alongside Tuttlingen in Germany and Sheffield in the United Kingdom, and it has supplied dental and surgical instruments across the Middle East for decades. GERATI operates under ISO 13485:2016, audited annually by an accredited third-party certification body, and carries CE marking under EU MDR 2017/745. Because Iraq imports nearly all of its medical equipment, the competition is between importers rather than against domestic manufacturing, and the quality argument rests on certification rather than country of origin. Pakistan also offers a practical advantage here in freight terms: Karachi to Umm Qasr is a short regional sea lane compared with shipping from Europe or East Asia. GERATI has supplied dental and surgical instruments to distributors and hospital procurement teams in more than 65 countries, operating since 1972 under the PHF Group.

Contact GERATI - Dental Syringe Supplier for Iraq

Email or WhatsApp with your specification, scientific office status and estimated annual volume. We respond within 2 working days with pricing, samples, and the full documentation pack for Ministry of Health registration.

  • Factory-direct pricing, no intermediary margin
  • ISO 13485:2016 certified, CE MDR 2017/745 marked
  • Ships Baghdad, Basra and Erbil in 5-8 working days
  • ICIGI conformity inspection arranged in Pakistan
  • Arabic and English labelling as standard
AA
Aqeel Abbas
Director of Marketing, GERATI Healthcare and PHF - Sialkot, Pakistan
Written by Aqeel Abbas, Director of Marketing at GERATI Healthcare , Sialkot, Pakistan. 30 years of direct export experience supplying dental and surgical instruments to distributors and hospital procurement teams across the Middle East, Gulf and Asia Pacific. Iraq regulatory and market information sourced from: US Department of Commerce Iraq Country Commercial Guide, healthcare and medical equipment chapter; Al Tamimi and Company guide to the Iraqi healthcare industry, covering Pharmaceutical Law No. 40 of 1970 and Instructions No. 4 of 1998 on scientific offices; COSQC ICIGI conformity programme documentation published by appointed certification bodies; KIMADIA; KRG Ministry of Health medical device import licence service. Registration requirements, validity periods, conformity procedures and inspection obligations cited here are drawn from published third-party guidance and should be confirmed with a registered Iraqi scientific office, and against the document list attached to the specific KIMADIA tender concerned, before commercial commitment. .
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