A Free Trade Certificate, or Free Sales Certificate, is a certificate issued by EU competent authorities to facilitate market entry into other markets worldwide.
Compliance with the EU requirements often grants access to many other countries outside the EU. Obelis will apply for your Free Sales Certificate (FSC) and make sure your products can be sold worldwide with no compliance issues.
A Free Sales Certificate confirms that the manufacturer’s devices are CE-marked and approved for sale in the EU market.
What is a Free Sales Certificate?
A Free Sales Certificate (or Free Trade Certificate) is a legalized document provided by the competent authority of an EU member state. The Free Sales Certificate is a confirmation that the devices sold by the manufacturer are CE marked and can be placed in the EU market. Due to the high standards, the European Union sets under its Medical Devices Regulations, the certificate is used by manufacturers to speed up their entry procedures in non-EU markets.
What are the main elements of the new FSCs?
The new Free Sales Certificates form requests crucial information from the manufacturer:
- Basic UDI-DI of each device part of the FSC (not needed for legacy devices);
- Notification number (in case of Class I devices & IVDs);
- Device name linked to the Basic UDI-DI or Notification number;
- Manufacturer’s name and address;
- Manufacturer’s authorised representative (applicable only for non-EU manufacturers)
- Manufacturer’s VAT number;
- Manufacturer’s CE Certificate (if applicable);
- Manufacturers ISO 9001/EN 13485 Certificate (if applicable);
Additionally, the manufacturer needs to answer questions concerning the existence of medicinal substances or cells or tissues of human origin, among others.
The Belgian competent authority has indicated that these new FSC are currently applicable also for legacy devices. FSCs issued under the old forms are no longer accepted.
If you want to apply for a Free Sales Certificate FSC certification, Obelis will:
For non-EU manufacturers, it is the authorized representative such as Obelis that requests the competent authority to issue the FSC. It is now possible for Obelis, as a regulatory consultant, to apply for an FSC even for EU-based companies.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
