Italian medical devices travel well: CE-marked products from Italian manufacturers are bought by hospitals, distributors and ministries across the Gulf, North Africa and Asia. Exporting them is not a single permit, though. It is a chain of documents that starts in the factory, passes through the Italian Ministry of Health and ends with a registration in the buyer's country, usually filed by a local representative. This page sets out that chain in order, for Italian manufacturers selling abroad and for the distributors and procurement teams importing their products.
Key points
- Every device must first be CE marked under Regulation (EU) 2017/745 (MDR), which has applied since 26 May 2021.
- Above the lowest risk class, a notified body must certify the device; its designation can be checked in the European Commission's NANDO database.
- Devices still sold under old directive certificates can stay on the market until 31 December 2027 or 31 December 2028, depending on class, only under the conditions of Regulation (EU) 2023/607.
- For countries outside the EU, the Italian Ministry of Health issues the certificate of free sale (CLV). Only manufacturers and authorised representatives based in Italy can request it.
- Saudi Arabia and the UAE require a licensed local representative, who files the registration with the SFDA or the Emirates Drug Establishment.
Step 1: confirm the CE marking and the notified body
The MDR classifies devices by risk, from Class I to Class III. For any device above the lowest class, a notified body audits the quality system and reviews the technical documentation before issuing a CE certificate. Most manufacturers run a quality system certified to ISO 13485, which notified bodies use as their baseline.
Before anything else, check that the notified body named on the certificate is designated under the MDR for that device category. NANDO is the public register that answers the question. A certificate from a body that is not designated for that category is worth nothing at a foreign customs desk.
Legacy devices deserve extra attention. Regulation (EU) 2023/607 extended the transition period: class III and class IIb implantable devices until 31 December 2027, other class IIb, class IIa and class I sterile or measuring devices until 31 December 2028. The extension applies only to devices that meet its conditions, so ask for the notified body's confirmation letter rather than assuming it.
Step 2: request the certificate of free sale from the Ministry of Health
Most authorities outside the EU ask for proof that the device is legally sold in its country of origin. For devices made in Italy, that proof is the certificato di libera vendita (CLV), issued by the Italian Ministry of Health for exports to countries outside the European Union.
- Who can apply: the manufacturer or its authorised representative, with registered office in Italy. A foreign distributor cannot request it directly.
- Prerequisite: the device must be registered and up to date in the Ministry's medical device database, with labels and instructions for use.
- Cost: the fee set by the Ministry plus Italian stamp duty of €16 per certificate.
- Do not substitute it: a generic free-sale attestation from a Chamber of Commerce does not replace the Ministry's certificate for medical devices.
Some destination countries also want the certificate legalised. Older UAE guidance, for example, asked for a certificate of free sale certified by the UAE embassy. Check the destination's current rule with the importer before ordering the document.
Step 3: appoint a local representative and register the device
Gulf regulators do not deal with foreign manufacturers directly. They require a licensed local company that answers for the product.
Saudi Arabia. The Saudi Food and Drug Authority requires a foreign manufacturer to appoint a Saudi authorised representative holding an SFDA licence. The relationship is set out in a written mandate. The representative files the medical device marketing authorisation (MDMA) application through the SFDA's electronic services, with labelling and instructions for use. Importing and distributing are separate roles with their own licences.
United Arab Emirates. Since 2 January 2025, the registration of medical devices has moved from the Ministry of Health and Prevention to the Emirates Drug Establishment (EDE). A foreign manufacturer without a UAE presence appoints a local authorised representative licensed by the EDE, who submits the application through its portal.
In both markets the representative also carries the post-market obligations: complaints, field safety notices and recalls. Choosing that partner is therefore a commercial decision as much as a regulatory one.
Step 4: prepare the shipment
Once the device is registered, each shipment needs the usual export file, checked against the registration: commercial invoice, packing list and certificate of origin, with product names and codes identical to those on the registration. A mismatch between the invoice description and the registered product name is one of the most common reasons for a consignment to be held at the border.
Keep a single document pack per product line: CE certificate, declaration of conformity, ISO 13485 certificate, certificate of free sale, labels and instructions for use in the languages the destination requires. Every new tender or importer will ask for the same set.
Conclusion
The order matters more than any single document: a valid CE certificate from a designated notified body, then the Ministry of Health's certificate of free sale, then a licensed local representative who registers the device, and only then the first shipment. Skipping a step usually means repeating several. Rules and fees in the destination countries change often, so confirm them with the regulator or your representative before each new market.
