Free sale certification has changed on both sides of the Atlantic. Since 2 January 2024, FDA's Center for Devices and Radiological Health (CDRH) has issued export certificates as downloadable PDFs through CECATS, which foreign governments can verify with the FURLS Export Certificate Validator (FDA: Exporting Medical Devices). Section 3304 of the Consolidated Appropriations Act, 2023, signed on 29 December 2022, amended section 801(e)(4) of the FD&C Act so that FDA can also certify devices made and shipped outside the United States (FDA: Devices Not Exported from the US). In the EU, the certificate rests on the MDR, which has applied since 26 May 2021.
Many non-EU regulators want proof that a device is legally sold in its home market before they register it. This article explains the EU certificate of free sale, how it works in the Netherlands, and the export certificates FDA issues.
What a certificate of free sale is
A certificate of free sale is an official document confirming that a device may be legally placed on the market in the issuing jurisdiction. It is not an approval to sell in the destination country. The destination regulator decides whether it needs one and what else it needs.
In our view, the certificate is derivative evidence. It is only as current as the CE certificate, declaration of conformity or FDA authorisation behind it, so reissues should be planned around certificate expiry dates and product changes.
The EU certificate under the MDR and IVDR
The legal basis is Article 60 of the MDR and Article 55 of the IVDR. According to the Commission factsheet for non-EU/EEA authorities, for export purposes the competent authority of the Member State where the manufacturer or its authorised representative has its registered place of business may issue a certificate declaring that the CE-marked device may be marketed in the Union. Certificates issued by any Member State have the same value.
The factsheet also states that the Basic UDI-DI is referenced in certificates of free sale. In our view, the Basic UDI-DI, the declaration of conformity and the certificate data should therefore match before an application is made. Our EUDAMED and UDI registration checklist covers how to align that data.
Legacy devices. Certificates of free sale can also be based on MDD or AIMDD certificates or declarations of conformity. The Commission's Q&A on Regulation (EU) 2023/607 says competent authorities should be able to issue them for the duration of the extended certificate validity. That is guidance, not an additional legal provision.
The Netherlands: export declarations at Farmatec
In the Netherlands, certificates of free sale are called export declarations and are issued by Farmatec, part of CIBG.
Who can apply: a manufacturer or authorised representative registered in the Netherlands. Importers, distributors and compilers of systems or procedure packs cannot apply.
How: online in NOTIS, with an eRecognition (eHerkenning) Level 2+ token.
Documents: for MDR devices, the declaration of conformity and, where applicable, the notified body certificate. For products registered in EUDAMED, Farmatec also asks for confirmation of the EUDAMED registration and a product list.
Validity: an MDR export declaration is valid for a maximum of five years, or until the expiry date of the CE certificate, whichever comes first. This is Farmatec's rule; the MDR itself does not set a validity period.
Legacy devices: export declarations for legacy devices can only be issued on the basis of the MDD, AIMDD or IVDD. Farmatec lists cut-off dates: 31 December 2027 for class III and most class IIb implantable devices, and 31 December 2028 for other class IIb, class IIa, and sterile or measuring class I devices, provided the conditions of Regulation (EU) 2023/607 are met.
Content: by default, the declaration lists only the group name and brand name. More detail requires a product list or production site appendix.
Cost and timing: EUR 62 per export declaration plus EUR 62 administration costs per invoice. A complete application is processed within four weeks.
FDA export certificates
The Export Reform and Enhancement Act of 1996 authorised FDA to issue export certificates and to charge a fee for each certificate issued within 20 days. CDRH issues four types (FDA: Types of Export Certificates):
| Certificate | Used for |
|---|---|
| Certificate to Foreign Government (CFG) | Devices that can be legally marketed in the US |
| Certificate of Exportability under 801(e)(1) | Devices that cannot be marketed in the US but meet the 801(e)(1) export conditions |
| Certificate of Exportability under 802 | Unapproved devices exported under section 802 |
| Non-Clinical Research Use Only Certificate | Devices for non-clinical research use |
Source: FDA, Types of Export Certificates.
CFG criteria. The device must be registered and listed, have a 510(k), PMA, De Novo or pre-1976 status, be labelled in line with 21 CFR 801 or 809, and meet the Quality Management System Regulation (21 CFR 820). Our article on registration of medical devices in the EU and US covers registration and listing.
Certificates of Exportability. Under 801(e)(1), the device must meet the foreign purchaser's specifications, not conflict with the laws of the importing country, be labelled for export, and not be sold or offered for sale in the US. Section 802 adds the conditions of 802(f) and, for some exports, marketing authorisation in a listed Tier 1 country, which includes the EU and EEA.
Certificates for devices not exported from the US (CFG-NE)
The 2022 amendment created a route for manufacturers that make devices outside the United States. A CFG-NE is available when the device:
is manufactured outside the US;
is authorised for marketing in the US;
is imported or offered for import into the US; and
is not subject to an open enforcement action.
In CECATS, the request is made by answering "No" to the question "Will the devices be exported from the United States?" (FDA export FAQs, FAQ 20).
FDA fees and handling
According to FDA's exporting page:
the fee is USD 175 for the first certificate and USD 85 for each additional certificate from the same request;
each PDF certificate is limited to 25 pages, including the manufacturer and product attachment pages, and an additional USD 175 is charged per 25 pages;
FDA invoices quarterly for all certificates issued in that quarter;
foreign governments and others can authenticate certificates with the FURLS Export Certificate Validator for as long as they are in effect, using the web address or QR code on each certificate; and
FDA does not notarise export certificates, although electronic certificates can still be apostilled.
Netherlands and FDA compared
| Aspect | Netherlands (Farmatec) | FDA (CDRH) |
|---|---|---|
| Issuer | Farmatec (CIBG), under Article 60 MDR / Article 55 IVDR | CDRH, under FD&C Act sections 801 and 802 |
| Who applies | Manufacturer or authorised representative registered in the Netherlands | The firm requesting the certificate; CFG-NE for devices made outside the US |
| System | NOTIS, with eRecognition Level 2+ | CECATS |
| Validity | Maximum five years, or until CE certificate expiry if earlier | Expiration date shown on the certificate and in the FURLS Export Certificate Validator |
| Fee | EUR 62 per declaration plus EUR 62 per invoice | USD 175 first certificate, USD 85 each additional |
| Format | Export declaration | Electronic PDF, verifiable through the FURLS Export Certificate Validator |
Sources: Farmatec; FDA, Exporting Medical Devices; Commission factsheet.
A hypothetical example
Hypothetical example: an Amsterdam SaMD manufacturer has MDR CE marking with a notified body certificate, and a 510(k) clearance in the US. A non-EU regulator asks for a certificate of free sale as part of a registration.
For EU evidence, the manufacturer applies to Farmatec in NOTIS with its MDR declaration of conformity and notified body certificate, after checking that the Basic UDI-DI, product names and certificate data match. The export declaration is valid for five years or until the CE certificate expires, whichever is earlier.
If the regulator asks for FDA evidence instead, the 510(k) alone is not enough. The manufacturer checks each CFG-NE condition: manufacture outside the US, US marketing authorisation, import or offer for import into the US, and no open enforcement action. Which certificate the destination accepts is a question for that regulator, and should be confirmed before either application is made.
Conclusion
A certificate of free sale documents a legal-market status that already exists; it does not create one. The EU certificate confirms that a CE-marked device may be marketed in the Union, and FDA's certificates answer different questions depending on whether the device is sold in, exported from or made outside the United States.
In our view, whether a certificate is needed is set by the destination market, so it belongs in the market-entry plan rather than being requested at the end. Keep each certificate linked to the CE certificate, declaration of conformity or FDA authorisation behind it, and reissue it when those change. If the request comes through a distributor, remember that in the Netherlands only the manufacturer or authorised representative can apply.
If you need support planning certificates and registrations for new markets, our global market registrations team can help, or contact MedQAIR.
Frequently asked questions
Can a distributor request a certificate of free sale in the Netherlands?
No. Farmatec only accepts applications from manufacturers and authorised representatives registered in the Netherlands. Importers, distributors and compilers of systems or procedure packs cannot apply.
How long is a Dutch export declaration valid?
An MDR export declaration from Farmatec is valid for a maximum of five years, or until the expiry date of the CE certificate if that is earlier.
Can a non-US manufacturer get an FDA certificate?
Yes. Since the Consolidated Appropriations Act, 2023, FDA can issue a CFG-NE for devices made outside the US, provided they are authorised for US marketing, imported or offered for import into the US, and not subject to an open enforcement action.
Are legacy devices covered?
Yes, on the basis of the MDD, AIMDD or IVDD. The Commission's Q&A says competent authorities should be able to issue certificates for the duration of the extended validity under Regulation (EU) 2023/607, and Farmatec lists cut-off dates of 31 December 2027 and 31 December 2028 depending on the device class.
How do foreign authorities check an FDA certificate?
They use FDA's FURLS Export Certificate Validator, through the web address or QR code on each certificate. FDA issues certificates as electronic PDFs and does not notarise them.
