🌍 Looking to expand your business globally with medical devices or IVD products? 🚀 Here’s what you need to know about the Free Sale Certificate (FSC)

A Free Sale Certificate (FSC) is a crucial document for manufacturers aiming to export medical devices and in vitro diagnostic (IVD) products to international markets. This certificate confirms that the products are marketed in Europe, comply with European regulations, and can be sold without export restrictions. 📜

Why is having an FSC essential for global expansion? 🤔

🔹 Facilitates Registration in New Markets: To register or renew products in non-European markets, manufacturers need a valid FSC that meets the requirements of the competent authorities. Not all FSCs are the same, and some may not be accepted in certain countries. 🛂

🔹 Choose a Recognized Reference Country: FSCs issued by “reference countries” such as Spain, the United Kingdom, Switzerland, Australia, and the USA have a high acceptance rate, ensuring a smoother entry into new markets. This can make the difference between a successful launch and a prolonged delay. 🌍

🔹 Avoid Regulatory Complications: A poorly managed FSC can lead to regulatory issues and costly delays. It is crucial to ensure that the certificate is correctly issued and aligned with the target market’s regulations.

🔹 Streamlined Process: Managing the acquisition of an FSC can be a complex process. Understanding specific regulations and preparing the right documentation is key to avoiding rejections and facilitating market access.

At CMC Medical Devices, we help companies obtain widely accepted FSCs, ensuring their products can enter new markets without complications. We handle the entire process so you can focus on growing your business.

📞 Contact us if you want to maximize your product’s global market potential and avoid regulatory hurdles. We are here to help you scale your business!