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EU Authorized Representative for Oman: From the Drug Safety Center List to MDR Article 11

Oman's Ministry of Health lists medical devices through its Drug Safety Center, on a form that asks for the legal manufacturer, the nomenclature code, the classification and, where one exists, a Saudi Food and Drug Authority marketing permission number. The European Union has no such form and no such field. A manufacturer established in Oman, or an Omani brand owner that is the manufacturer under Article 2(30), meets Regulation (EU) 2017/745 through technical documentation, a declaration of conformity, EUDAMED and, before anything is placed on the market, a sole authorized representative under Article 11(1). This page sets out those steps and why one mandate with Medex in Türkiye covers the Union and Türkiye together.

What the Omani listing form asks, and what the Union asks instead

In Oman the Ministry of Health (moh.gov.om) describes its mandate as regulating and monitoring the manufacture, importation, distribution and utilisation of medicines, health preparations, medical devices and equipment. The ministry's Drug Safety Center states that it oversees medicines, medical devices and medical supplies in the Omani market, and its services page lists "Listing medical products and devices": supplier companies submit an Excel file for inclusion in the master list, giving, among other fields, the legal manufacturer, the manufacturing site if different, the model number, the global nomenclature code, category, classification, whether the device contains a medicine, whether the applicant is the local agent, and the Saudi Food and Drug Authority marketing permission number if any.

That last field is the point of departure. The Omani list leans on another regulator's authorisation. The Union leans on no one. Regulation (EU) 2017/745 has no field for a foreign approval and no reliance route; the CE marking is the manufacturer's own declaration, backed by technical documentation and, above class I, by a notified body certificate.

Omani master-list fieldMDR counterpart
Factory title (legal manufacturer)Manufacturer under Article 2(30): the person who markets the device under its name or trademark
Address of the manufacturing site if differentNamed in the technical documentation; the label carries the manufacturer's registered place of business (Annex I, 23.2(c))
Global nomenclature codeEMDN code recorded in EUDAMED with the Basic UDI-DI
ClassificationClass I, IIa, IIb or III under Annex VIII; it fixes the conformity assessment route
SFDA marketing permission number, if anyNo equivalent. The Union recognises no third-country authorisation
Are you the local agent?Authorized representative under Article 11, established within the Union; importer under Article 2(33)

Article 11(1) applies to Muscat as it applies to Doha or Riyadh

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative."

Regulation (EU) 2017/745, Article 11(1).

An Omani manufacturer, or an Omani brand owner that is the manufacturer under Article 2(30), designates its representative before the first placing on the market. The representative is defined as:

"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;"

Regulation (EU) 2017/745, Article 2(32).

Türkiye and the Union market

"The ’Union market’ refers to the territories of the European Union Member States, and due to the European Economic Area (EEA) is extended to Norway, Lichtenstein and Iceland, and via the Customs Union Agreement to Turkey."

MDCG 2022-16, footnote 1.

Medex is established in Ankara and holds EUDAMED authorized representative single registration number TR-AR-000057550. A mandate with Medex covers the Union and Türkiye for the generic device group it names. The sole-representative principle is explained in the same guidance:

"However, for one specific generic device group, the manufacturer should designate only one authorised representative (i.e. a ‘sole’ authorised representative’)."

MDCG 2022-16, section 4.

If the devices are also sold in Türkiye, the Turkish importer registers them in ÜTS (Ürün Takip Sistemi), Türkiye's product tracking system; we do that for importers as a separate contract.

Omani documents abroad

Oman is a Contracting Party to the Apostille Convention. The HCCH status table records accession on 12-V-2011 and entry into force on 30-I-2012. The mandate needs no Apostille, because Article 11(2) requires only written acceptance by the representative. An Omani Apostille is used where an Omani corporate or signatory document is presented to a national authority, for example by a Turkish importer in its ÜTS file, together with a sworn Turkish translation.

The ministry publishes in Arabic and English. For the Union file English is the working language, because of the obligation in Article 11(3)(d):

"in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;"

Regulation (EU) 2017/745, Article 11(3)(d).

Registration and the person responsible for regulatory compliance

"After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer."

Regulation (EU) 2017/745, Article 31(2).

The manufacturer and the representative each hold an SRN; the mandate record links them, and the devices sit beneath it under their Basic UDI-DIs. The steps are listed under EUDAMED registration. On our side the Regulation requires a named person:

"Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union."

Regulation (EU) 2017/745, Article 15(6), first sentence.

Medex is an authorized representative under Article 11 and nothing else in the chain. We are not a notified body: a notified body is, in the words of Article 2(42), "‘notified body’ means a conformity assessment body designated in accordance with this Regulation;" and only such a body can issue the certificate a class IIa, IIb or III device needs. We are not your importer or distributor either; the importer is the Union entity that physically places your consignment on the market, and that role carries its own duties under Article 13.

Fees are listed on our pricing page: "Fees from EUR 800 a year, no setup fee, one mandate." and "Fees are in euros, exclude VAT, and are fixed for three years from signature."

Gulf pages: United Arab Emirates, Saudi Arabia and Qatar.

Frequently asked questions

Our device is on the Drug Safety Center master list in Oman. Does the EU accept that?

No. The master list is an Omani record. Regulation (EU) 2017/745 does not recognise third-country listings or registrations. Conformity is shown through technical documentation and, above class I, a notified body certificate.

The Omani listing form asks for an SFDA marketing authorisation number. Is there an EU equivalent we can quote?

No. The Union has no reliance field. The EU side is the CE marking on the basis of the manufacturer's own conformity assessment, the EU declaration of conformity and the EUDAMED registration.

Who is the manufacturer if an Omani company sells a device made abroad under its own brand?

The Omani company, under Article 2(30), because it markets the device under its name or trademark. It then carries Article 10 and must designate the representative under Article 11(1).

Does an Apostille from Oman work in Türkiye?

Yes. Oman is a Contracting Party to the Apostille Convention, so an Omani public document with an Apostille is accepted in Türkiye without consular legalisation. A sworn Turkish translation is then added. The mandate itself needs no Apostille.

Can one mandate cover the European Union and Türkiye?

Yes. MDCG 2022-16 states that the Union market extends to Türkiye via the Customs Union Agreement. One mandate with a representative established in Türkiye covers both for the generic device group it names.

Send us the Excel you filed with the Drug Safety Center master list and the name on your label, and we will tell you which entity is the manufacturer, the MDR class per device and what the mandate covers. Request a proposal.

Sources and further reading

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