Services
Free Sales Certificate (FSC) Service
Selling products within the European Union must comply with the EU-regulations MDR and IVDR. Non-EU manufacturers are forced to appoint an EC-REP. A compliance with EU regulations allows EU and non-EU manufacturers to sell their medical products in many other countries of around the world. Therefore they need a so called Free Sales Certificate that is issued by an EU competent authority. MedNet helps you as manufacturer to gain access to other countries worldwide with a Representation within the EU and a Free Sales Certificate.
EU-members
Manufacturers who want to apply for a Free Sales Certificate must comply with the EU regulations. We support you by offering following services:
- Acting as your authorised representative
- Check of your compliance with the EU Regulations for Medical Devices (MDR) and In-Vitro Diagnostic Devices (IVDR).
- Collecting all necessary information for the FSC application and applying for the Free Sales Certificate
- Providing manufacturers with the FSC manufacturers with the FSC ready to be used with non-EU competent authorities
As your Authorized Representative MedNet EC-REP supports EU-based manufacturers of IVD and medical devices to apply for a Free Sales Certificate and assists you with additional services.
non-EU members
Non-EU manufacturers are forced to appoint an European Authorized Representative to sell their products in the European Union. To obtain a Free Sales Certificate these products have to adhere to EU regulations.
We offer a range of services to support non-EU manufacturers in this process, including:
- Serving as your European Authorized Representative
- Ensuring your compliance with EU Regulations for Medical Devices (MDR) and In-Vitro Diagnostic Devices (IVDR)
- Gathering all essential information required for the Free Sales Certificate application
- Managing the application for the Free Sales Certificate on your behalf
- Providing manufacturers with a fully prepared Free Sales Certificate that can be submitted to non-EU competent authorities
As your European Authorized Representative, MedNet EC-REP is dedicated to assisting non-EU-based manufacturers of IVD and medical devices in their pursuit of a Free Sales Certificate asd well as offering a range of supplementary services to facilitate the process.
Looking to expand your medical device or IVD sales beyond Europe?
Gain access to global markets with our Free Sales Certificate (FSC) Service.
Don’t let paperwork slow down your global expansion.
Contact us today and let’s take your products to the world.
Frequently asked Questions
A Free Sales Certificate (FSC) is a document issued by the relevant regulatory authorities that certifies that a medical device is freely sold in a particular country or region.
The process for obtaining an FSC varies depending on the country or region where you intend to sell your medical device. In general, the EC-REP will need to submit an application to the regulatory authority responsible for medical device regulation in the target market. This application will typically require documentation demonstrating the safety, efficacy, and compliance of your product with local regulations.
While specific requirements may vary, common documents requested during the FSC application process may include:
- Product technical documentation, including design specifications and test reports.
- Quality management system documentation, such as ISO 13485 certification.
- Clinical data and/or evidence of product safety and efficacy.
- Labeling and packaging information.
- Manufacturing facility information and inspection reports.
The timeframe for obtaining an FSC can vary significantly depending on the regulatory authority or embassy and the complexity of your application. In some cases, it may take several weeks or even months to complete the review process and receive the certificate.
The validity period of an FSC can vary depending on the regulatory authority and the type of medical device. In some cases, FSCs may need to be renewed periodically to ensure ongoing compliance with regulatory requirements.