EU Authorized Representative for Ghana: From an FDA Ghana Local Agent to MDR Article 11
Ghana's Food and Drugs Authority registers medical devices under the Public Health Act, 2012 (Act 851) and sorts them into four risk classes, I to IV, using rules modelled on Canada's. The numbers look familiar to anyone who knows the MDR, but they do not line up: a class III device in Accra can be class IIb or class III in Europe, and some Ghanaian class I instruments need a notified body in the Union. A Ghanaian manufacturer selling in the EU under its own name needs CE marking under Regulation (EU) 2017/745 and a sole authorised representative established in the Union or in Türkiye.
Four classes in Ghana, four classes in the MDR, different boundaries
The FDA Ghana Guideline for Registration of Medical Device (FDA/MCH/MDD/GL-RMD/2013/01) states:
"Medical devices are classified into four groups, based on a risk assessment. Class I represents the group with the lowest risk and Class IV represents the group with the highest risk." (Guideline, Section 3.3.1)
The MDR also has four classes:
"Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII." (MDR Article 51(1))
The Ghanaian rules in Appendix IV of the guideline follow the Canadian scheme, so the class numbers do not translate one to one. Three examples from the two texts show where manufacturers get caught:
| Device | FDA Ghana (Appendix IV) | MDR (Annex VIII) |
|---|---|---|
| Surgical or dental instruments | Class I (Rule 3(b)) | Class I for reusable surgical instruments, but the notified body assesses the reuse aspects (Rule 6, Article 52(7)) |
| Surgically invasive device absorbed by the body or used for 30 days or more | Class III (Rule 1(3)) | Class IIb as a baseline, class III if wholly or mainly absorbed (Rule 8) |
| Active therapeutic device controlling treatment through a closed loop | Class IV (Rule 9(3)) | Class III (Rule 22) |
A Ghanaian class is a useful reference for the technical file. It is not an MDR class, and the notified body classifies against Annex VIII. Our free MDR classification checker walks through the Annex VIII rules and quotes the rule text behind each result.
FDA Ghana registration has no effect in the EU
The guideline requires cGMP compliance before any product is registered:
"No product shall be registered unless the facility complies with cGMP. The report of the cGMP inspection will form part of the registration process." (Guideline, Section 3.1.7.3)
The guideline was written with reference to the medical device regulations of the USA, Canada and Australia, GHTF guidance and European standards (Guideline, Section 1.0). That shared vocabulary helps when preparing an EU file, but no Ghanaian decision is recognised in the Union.
| Ghanaian instrument | What it does in Ghana | Effect in the EU |
|---|---|---|
| FDA Ghana product registration | Authorises marketing in Ghana | None |
| FDA Ghana cGMP inspection report | Confirms the facility for Ghanaian registration | None; the notified body audits the quality management system itself |
| Local agent with power of attorney | Represents a non-resident applicant before the FDA | None; it cannot act as EU authorised representative |
| Ghana class I to IV | Sets the Ghanaian evaluation route | None; Annex VIII applies |
Local agent and EU authorised representative
Ghana's local agent is defined as "a corporate body registered in Ghana, with the relevant mandate from the applicant, to act on the applicant's behalf as regards matters relating to the registration of a medical device(s) in Ghana" (Guideline, Section 3.1.3). The guideline gives the agent market monitoring, communication with the Authority, recall handling and technical support for users.
The EU role is defined by establishment in the Union and a written mandate:
"‘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;" (MDR Article 2(32))
Several tasks look alike on paper. The difference is liability and scope. Under Article 11(5) the EU authorised representative is jointly and severally liable with the manufacturer for defective devices, and the mandate cannot be delegated. A Ghanaian local agent who also distributes your products does not become your EU representative, and a European distributor should not be one by default.
Language and documents
FDA Ghana accepts applications in English only and asks for translations to be authenticated at the nearest Ghana Embassy or by the regulator of the country of origin (Guideline, Section 3.1.5). EU labels and instructions for use follow the language rules of each Member State under Article 10(11); English covers Ireland and Malta. The EU declaration of conformity follows Annex IV and names the authorised representative with its Single Registration Number.
Getting the Union side in place from Accra or Kumasi
Medex Kurumsal Danışmanlık is established in Türkiye. The European Commission's Notice to Stakeholders of March 2022 states that manufacturers established outside the territory of the EU or Turkey "only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." Switzerland, Great Britain and the EEA-EFTA states require their own local representatives; Medex does not act for those markets.
The steps on our side:
1. Written mandate under Article 11(3). It records the minimum tasks, including verifying that the declaration of conformity and technical documentation exist and keeping copies available to competent authorities.
2. EUDAMED actor registration. Your company registers as manufacturer and receives its Single Registration Number, linked to our authorised representative SRN TR-AR-000057550.
3. UDI. Basic UDI-DI and UDI-DI data are registered for each device before it is placed on the market.
4. Person responsible for regulatory compliance. Medex's PRRC is in-house, as the Regulation requires:
"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." (MDR Article 15(6))
5. Label and IFU address. Annex I, Section 23.2(d) requires our name and registered address on the label of a device whose manufacturer is established outside the Union.
Medex works from Ankara, İstanbul and Gdańsk. We do not write technical documentation, we are not a notified body, and we do not find distributors. Annual fees are published on our pricing page, from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative.
Related country and guidance pages
Manufacturers in neighbouring markets face similar questions; we keep separate pages for Nigeria, Kenya and South Africa. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.
Frequently asked questions
Our device is class II with FDA Ghana. Is it class IIa under the MDR?
Not necessarily. Ghana's rules follow the Canadian scheme, so the class boundaries differ from the MDR. Classify the device under Annex VIII; our free MDR classification checker quotes the rule text for each result.
Our surgical instruments are class I in Ghana. Do we need a notified body in the EU?
If they are reusable surgical instruments, yes, for the reuse aspects. Article 52(7) limits the notified body's role to cleaning, disinfection, sterilisation, maintenance, functional testing and the related instructions for use.
Can our Ghanaian local agent act as our EU authorised representative?
No. The MDR requires the authorised representative to be established within the Union; the Commission's 2022 notice extends this to Türkiye under the Customs Union. A company established only in Ghana cannot accept the mandate.
Does a Türkiye-based representative cover the whole EU?
Yes. The Commission's March 2022 notice confirms that manufacturers outside the EU and Turkey need only one authorised representative, either in the EU or in Turkey, to place devices on the market in the EU. Switzerland, Great Britain and the EEA-EFTA states require their own local representatives.
Sources
Food and Drugs Authority, Ghana — Guideline for Registration of Medical Device, FDA/MCH/MDD/GL-RMD/2013/01, version 02 — fdaghana.gov.gh
Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu
MDCG 2021-24 Rev.1, Guidance on classification of medical devices — health.ec.europa.eu
European Commission — Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu
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Related guides
Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.
Other countries we cover
We act as EU authorized representative for manufacturers in many markets. See the pages for Kenya, South Africa, Türkiye, Israel, the United States and China, or browse the full list by country and the list by device category.
If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.