--- title: Free Sale Certificates: What They Are and When Your Startup Needs Them description: What free sale certificates are, when MedTech startups need them, how to obtain them, and their role in international market access beyond the EU under MDR. authors: Tibor Zechmeister, Felix Lenhard category: MDR Fundamentals & Regulatory Strategy primary_keyword: canonical_url: https://zechmeister-solutions.com/en/blog/free-sale-certificates-what-they-are-when-startup-needs-them source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # Free Sale Certificates: What They Are and When Your Startup Needs Them *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* If you are focused solely on the EU market, you may never have heard of a Free Sale Certificate. But the moment you look beyond Europe — at markets in the Middle East, Southeast Asia, Latin America, or Africa — these two words will appear on every regulatory checklist you encounter. A Free Sale Certificate (FSC) is a document issued by a competent authority in the manufacturer's country of origin confirming that a medical device is legally marketed (freely sold) in that country. It is proof that your device has cleared the regulatory hurdles in its home market. For MedTech startups, FSCs are a gateway to international expansion. Many countries that do not have their own full-scale medical device regulatory systems rely on CE marking (or FDA clearance) as evidence of safety and performance — and they require an FSC as the formal proof that the approval exists. ## What a Free Sale Certificate Contains An FSC typically contains: - The manufacturer's name and address - The device name and description - A statement that the device is legally marketed in the issuing country - The CE mark status (for EU-based certificates) - The classification of the device - The issuing authority's name, stamp, and signature - A date of issuance (and often a validity period) The exact content and format vary by issuing authority. There is no single international standard for FSCs, though most follow similar patterns. Some countries have specific requirements for what the FSC must state — make sure you know your target market's requirements before requesting an FSC. ## Who Issues Free Sale Certificates in the EU? In the EU, Free Sale Certificates are issued by the **competent authority** of the Member State where the manufacturer is established (or where the authorized representative is located, for non-EU manufacturers). Each EU Member State has its own competent authority for medical devices. For example: - **Austria:** BASG (Bundesamt fur Sicherheit im Gesundheitswesen) - **Germany:** BfArM (Bundesinstitut fur Arzneimittel und Medizinprodukte) - **France:** ANSM (Agence nationale de securite du medicament et des produits de sante) - **The Netherlands:** IGJ (Inspectie Gezondheidszorg en Jeugd) The process for obtaining an FSC varies by Member State. Some have online application systems. Some require paper applications. Processing times range from a few days to several weeks. ## When Your Startup Needs an FSC ### International Market Registration The most common use case. Many non-EU countries require an FSC as part of their medical device registration or import process. Examples include: - **Saudi Arabia (SFDA):** FSC required for device registration - **Brazil (ANVISA):** FSC required for device registration - **Australia (TGA):** FSC may be required depending on the registration pathway - **Many Middle Eastern, African, and Asian markets:** FSC is a standard requirement If your international expansion plans include any of these markets, FSCs will be on your checklist. ### Distributor Requirements International distributors often require FSCs before they will agree to distribute your product. The FSC gives them confidence — and regulatory cover — that they are distributing a legally marketed device. ### Tender and Procurement Requirements Hospital procurement departments and government tenders in many countries require FSCs as part of the bid documentation. Without an FSC, your bid may be disqualified regardless of how good your device is. ## The Relationship Between CE Marking and Free Sale Certificates The CE mark and the FSC serve different purposes but are closely related: - The **CE mark** is the regulatory compliance marker for the EU market. It demonstrates that your device meets MDR requirements. - The **FSC** is the documentary proof — issued by a government authority — that your device is legally marketed. It points to the CE mark (and the underlying conformity assessment) as the basis for that legal marketing. You cannot get an FSC without first having a valid CE mark (or equivalent legal market access). The FSC is downstream of the CE mark — it is a consequence of having market access, not a substitute for it. For the EU context under MDR, the FSC confirms that: 1. The manufacturer is registered in the relevant EU Member State 2. The device has a valid EU Declaration of Conformity 3. The device bears the CE mark in accordance with MDR 4. If required, a valid Notified Body certificate exists ## How to Obtain a Free Sale Certificate The process is generally straightforward but varies by Member State: ### Step 1: Ensure Your Device Is Legally on the EU Market Before requesting an FSC, your device must have: - A valid EU Declaration of Conformity - CE marking affixed per MDR Article 20 - Registration in EUDAMED (to the extent the relevant modules are operational) - A valid Notified Body certificate (if required for your device class) ### Step 2: Apply to the Competent Authority Submit an application to the competent authority of your Member State. The application typically requires: - Manufacturer identification - Device identification (name, model, catalogue numbers) - CE marking evidence (copy of DoC, NB certificate if applicable) - EUDAMED registration confirmation - Application fee (varies by country, typically EUR 50-500 per certificate) ### Step 3: Wait for Processing Processing times vary from a few business days (some Scandinavian authorities) to several weeks (some larger Member States with higher volumes). Plan ahead if you have registration deadlines in your target markets. ### Step 4: Receive and Distribute the FSC The authority issues the FSC, typically as a stamped and signed document. Some authorities issue digital certificates. You then provide copies to your international distributors, importers, or regulatory agents in the target markets. ## Apostille and Legalization Some countries require FSCs to be apostilled or legalized before they are accepted. An apostille is a certification under the Hague Apostille Convention that authenticates the document for use in another country. If your target market requires an apostille: 1. Obtain the FSC from the competent authority 2. Submit it to the designated apostille authority in the same country (usually the Ministry of Foreign Affairs or equivalent) 3. The apostille is affixed to or attached to the FSC 4. Submit the apostilled FSC to the target market authority Some countries that are not party to the Hague Convention may require full consular legalization instead, which involves the embassy or consulate of the target country. This adds time and cost. **Startup tip:** Factor apostille and legalization timelines into your international registration planning. It can add 2-6 weeks to the process. ## FSC Validity and Renewal FSCs typically have a limited validity period — often 12 months from the date of issuance, though this varies by issuing authority and target market requirements. Some target markets specify the maximum age of an FSC they will accept (for example, "FSC must be no more than 6 months old at the time of submission"). This means FSCs are not one-time documents. If you are maintaining registrations in multiple international markets, you need a process for tracking FSC expiration dates and renewing them in time. Tibor's practical advice: "Create a spreadsheet — or better, a tracker in your QMS — that lists every FSC you have issued, its validity date, and the target market it serves. Set reminders to request renewals well before expiration. Running out of a valid FSC can delay a registration renewal in a target market, which can mean losing market access temporarily." ## Common Startup Questions About FSCs ### "Can I get an FSC before I have the CE mark?" No. The FSC confirms that your device is legally marketed. Without a CE mark, it is not legally marketed in the EU, and no competent authority will issue an FSC. ### "Can I get an FSC from any EU Member State?" Typically, the FSC must be issued by the competent authority of the Member State where the manufacturer is established (or where the authorized representative is located). You cannot usually shop around for the fastest or cheapest authority. ### "Does the FSC prove that my device is safe?" Not directly. The FSC proves that your device is legally marketed in a specific country. The legal marketing is based on the conformity assessment (CE marking), which demonstrates safety and performance. The FSC is a proxy, not a direct safety attestation. ### "How much does an FSC cost?" Fees vary by Member State. Typical ranges are EUR 50-500 per certificate. Some authorities charge per device, others charge per application regardless of the number of devices. The cost is modest compared to the overall regulatory investment, but it adds up if you have many devices and many target markets. ### "Can my authorized representative request the FSC on my behalf?" In some Member States, yes — the authorized representative can act on behalf of the manufacturer. In others, the manufacturer must apply directly. Check with the specific competent authority. ## Strategic Considerations for Startups ### Plan International Before You Need It If international expansion is on your roadmap (even a distant one), plan for FSCs from the beginning. Ensure your manufacturer registration, EUDAMED entries, and DoC are all clean and accurate — because the FSC process will expose any inconsistencies. ### Choose Your EU Base Strategically If you are a non-EU startup choosing where to establish your authorized representative, consider the FSC process in that Member State. Some authorities are faster and more efficient than others. This should not be the primary factor in choosing your EU base, but it is worth considering if international markets are central to your strategy. ### Batch Your FSC Requests If you sell in multiple international markets, you will need FSCs regularly. Some competent authorities allow batch requests for multiple devices in a single application. Check the options and batch where possible to reduce administrative effort and cost. ### Use FSCs as a Commercial Asset An FSC is proof that a trusted regulatory authority has confirmed your market access. In commercial discussions with international distributors and partners, the FSC is a credibility marker. It demonstrates that your device has passed regulatory scrutiny in one of the world's most demanding regulatory environments. ## The Connection to MDR MDR does not specifically regulate Free Sale Certificates — they are governed by national administrative procedures. But MDR creates the foundation on which FSCs are built. Your CE marking under MDR is the prerequisite. Your EUDAMED registration provides the data. Your DoC is the legal basis. As EUDAMED becomes more fully operational, it may eventually serve as a direct verification source for international authorities — reducing or potentially replacing the need for paper-based FSCs. But that is a future development. For now, paper FSCs remain the standard mechanism. ## The Bottom Line Free Sale Certificates are a simple but essential document for MedTech startups with international ambitions. They are the bridge between your EU CE marking and market access in dozens of countries worldwide. The process for obtaining them is straightforward — once you have your CE marking in order. The cost is modest. The administrative effort is manageable. The key is planning: know which markets require FSCs, know the timelines and validity periods, and build FSC management into your regulatory operations from the start. The last thing you want is a distribution deal delayed by a missing piece of paper that takes three weeks to obtain. --- *This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*