Certificate of Free Sale for UAE Medical Device Registration

‍What it is, where to get it, and how to authenticate it for MoHAP

The MoHAP Requirement

The Certificate of Free Sale is one of the mandatory documents for medical device registration in the UAE. MoHAP's requirement is straightforward: submit "a valid certificate of free sale/registration issued by the competent authorities in the country of origin certified by the Embassy of the United Arab Emirates."

Two things matter here.

First, the CFS must come from a regulatory authority. Not from a chamber of commerce or trade organisation.

Second, the document must be authenticated by the UAE Embassy before submission. This authentication step is where most delays occur.

The CFS serves as evidence that your device is legally marketed somewhere. MoHAP wants confirmation that a competent authority in your home market has permitted the device to be sold. This is different from requiring a specific approval like a CE Mark or 510(k), though those approvals are often what enables you to obtain a CFS in the first place.

Obtaining a CFS from the United States

The FDA issues Certificates to Foreign Government (CFG) through the CDRH Export Certification Application and Tracking System (CECATS). Since January 2024, certificates are issued as downloadable PDFs with QR codes for verification.

Your manufacturing facility must be registered with FDA. Your devices must be listed. The device must be legally marketed in the US, meaning it has 510(k) clearance, PMA approval, or is exempt from premarket notification. The facility must comply with Quality System Regulation (21 CFR 820).

The fee is USD 175 for the first certificate and USD 85 for each additional certificate on the same order. Processing typically takes 2-3 weeks.

For devices not FDA-cleared but intended for export only, a Certificate of Exportability under Section 801(e)(1) or Section 802 exists. Whether MoHAP accepts these should be verified before proceeding.

One point that catches manufacturers by surprise: the FDA issues CFGs to US-based entities only. If your company is headquartered outside the US, you will need to work through a US Agent or subsidiary.

Obtaining a CFS from the United Kingdom

The MHRA issues Certificates of Free Sale for devices bearing UKCA, CE, or CE UKNI marks. Applications go through the MHRA's online Device Registration System.

The applicant must be a UK-based manufacturer, a UK Responsible Person, or a Northern Ireland-based Authorised Representative. Foreign manufacturers must work through their UK Responsible Person.

The fee is £75 for the first 10 certificates on an order, plus £10 for each additional certificate. MHRA targets 10 working days for processing. Certificates are issued as PDFs with electronic signatures. Physical certificates with wet signatures are no longer available.

If you hold both MDD/IVDD legacy CE Marks and MDR/IVDR CE Marks for different products, you may need separate certificates. Given that MDD-marked devices can no longer be placed on the market after December 2028, a CFS referencing only MDD compliance may have limited utility for long-term UAE registration.

Obtaining a CFS from the European Union

Each EU member state issues its own Certificates of Free Sale through its national competent authority. There is no single EU-wide certificate.

Common issuing authorities include HPRA in Ireland, BfArM in Germany, and ANSM in France. You must provide details of your EU Declaration of Conformity, your EC/EU Certificate from a Notified Body (for devices requiring one), and confirm that the devices are legally placed on the EU market.

Processing times and fees vary by country. Some authorities process requests within days. Others take several weeks. The Irish HPRA requires that CE Marking certificates be valid for at least six months at the time of application.

If you have an Authorised Representative in one country and your Notified Body is in another, either country's competent authority may be able to issue the certificate. Consider processing times, fees, and your ongoing relationship with each authority when deciding.

Obtaining a CFS from Russia

Russian manufacturers face a specific challenge. Roszdravnadzor (the Federal Service for Surveillance in Healthcare) issues registration certificates for medical devices, but the format differs from Western-style Certificates of Free Sale.

For devices registered under the national Russian system, Roszdravnadzor can issue a document confirming the device is legally marketed in the Russian Federation. For devices registered under the EAEU framework, the relevant documentation comes from the EAEU registration process.

Whether MoHAP accepts these as equivalent to a traditional CFS should be confirmed before submission. Acceptance may depend on the specific document format and content.

The authentication process from Russia follows the standard non-Hague Convention path. Start with notarisation by a Russian notary if required. Then authentication by the Russian Ministry of Foreign Affairs. Then legalisation by the UAE Embassy in Moscow. Finally, attestation by the UAE Ministry of Foreign Affairs upon arrival in the UAE.

Plan for 3-6 weeks for the full authentication chain.

Alternative route for Russian manufacturers with CE Marks: If you hold a CE Mark through a European Authorised Representative, you can obtain the CFS from the EU member state where your AR is based. This route is often faster and produces a document format that MoHAP reviewers see regularly. The device does not need to be manufactured in the EU. It only needs to be legally placed on the EU market.

Given the growing Russia-UAE trade relationship, this pathway is increasingly common.

The Authentication Step: Why UAE Is Different

This is where many manufacturers encounter problems. The UAE is not a party to the Hague Apostille Convention. An apostille stamp, which is sufficient for document authentication between Convention members, has no legal effect in the UAE.

Instead, documents must go through full consular legalisation. This is a multi-step process that varies by country.

From the United States: Start with notarisation if the document is not already government-issued. Then authentication by the relevant State's Secretary of State office. Then authentication by the US Department of State in Washington, DC. Finally, legalisation by the UAE Embassy or Consulate.

From the United Kingdom: Start with legalisation by the UK Foreign, Commonwealth and Development Office (FCDO). Then attestation by the UAE Embassy in London. Finally, attestation by the UAE Ministry of Foreign Affairs after arrival in UAE.

From the European Union: The process varies by member state but follows a similar pattern. National foreign ministry authentication, followed by UAE Embassy legalisation, followed by UAE MoFA attestation.

From Russia: Russian notary, then Russian Ministry of Foreign Affairs, then UAE Embassy in Moscow, then UAE MoFA upon arrival.

The UAE has introduced a Digital Attestation Service through its embassies and the Ministry of Foreign Affairs. Documents processed through this system receive electronic authentication that can be verified at verify.mofa.gov.ae. This has reduced processing times in some cases, though not all document types have fully transitioned.

Plan for 2-6 weeks depending on the country and current workload. From the US, total authentication costs (excluding professional service fees) can reach USD 200-400 per document.

When You Cannot Obtain a CFS

Some manufacturers face a genuine problem: they want to enter the UAE market with a device that is not yet approved or marketed in any reference market. Perhaps they are a startup with a novel device, or a manufacturer from a country that does not issue Certificates of Free Sale.

MoHAP's requirements do not offer an explicit exception. But registration is not necessarily impossible.

The ministry evaluates applications on their substance. If you can demonstrate compliance through other means, a path may exist. This includes CE Marking certificates, Notified Body documentation, ISO 13485 certification, and comprehensive technical files. Early engagement with your local Authorised Representative is essential in these situations.

For devices manufactured in countries without established CFS-issuing systems, an alternative is to obtain a CFS from a third country where the device is marketed. If your device is CE Marked and sold in the EU, you can obtain a CFS from an EU member state regardless of where the device is manufactured.

Practical Considerations for Submission

The CFS you submit to MoHAP should match the other details in your application. The product name, manufacturer name, and manufacturing site should align across all documents. Discrepancies create questions that delay review.

MoHAP does not specify a minimum validity period for the CFS. But submitting a certificate that is about to expire invites complications. If your underlying CE Mark or 510(k) is approaching renewal, time your CFS request accordingly.

Obtain multiple copies of authenticated certificates if you anticipate registering devices in batches or if you may need the same documents for other GCC countries. The marginal cost of additional certificates is low compared to repeating the authentication process.

Some manufacturers attempt to use a single CFS listing multiple devices. Whether this is accepted depends on how the certificate is structured. When in doubt, separate certificates for each device or device family reduce the risk of rejection.

How Kayrouz & Associates Can Help

We work with medical device manufacturers at various stages of UAE market entry, including Russian and CIS-based companies navigating both regulatory and corporate setup requirements.

Where the Certificate of Free Sale is concerned, our role typically involves advising on documentation strategy, identifying potential issues before they cause delays, and coordinating with local partners on authentication and submission.

If you are planning UAE registration and have questions about CFS requirements or the authentication process, contact our healthcare regulatory team for an initial discussion.

For detailed guidance on the full MoHAP registration process, see our comprehensive guide: How to Register a Medical Device in the UAE.

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