Under Directives 93/42/EC, 98/79/EC or 90/385/EC the certificate of free sale is a declaration confirming that the devices concerned comply with the applicable legislation and that the authority has not taken any restrictive measures with regard to the placing on the market of these devices. Under Regulations 2017/745 or 2017/746 the certificate of free sale attests that the manufacturer or its authorised representative has its registered place of business in Belgium, that the device bears the CE mark in accordance with Regulation 2017/745 or Regulation 2017/746 and that it can be marketed in the Union.
No, a certificate of free sale is generally intended for the export of medical devices outside the European Union.
Processing time per file is 5 weeks. This period begins when the file is complete.
For certificates of free sale under the Directive, the applicant may be the manufacturer, authorised representative, a distributor or exporter. They must be listed in our web portal as an "exporter". If the applicant and the manufacturer are not the same person, a declaration from the "license holder" must be attached. Either the manufacturer or the applicant must be based in Belgium to be able to apply for a certificate of free sale. For certificates of free sale under the Regulation, only the manufacturer or authorised representative can apply for a certificate of free sale (see Art. 60 of Regulation 2017/745 or Art. 55 of Regulation 2017/746). One of these must be based in Belgium.
Yes, a certificate of free sale is also called a Free Sale Certificate.
- The completed form
- A copy of the declaration of conformity
- The notification number provided by the competent authority
- A copy of the ISO 9001 and EN/ISO 13485 certificates
- or sterile medical devices, measuring medical devices and reusable surgical instruments, a copy of the CE certificate is also required.
- The completed form
- A copy of the declaration of conformity
- A copy of the CE certificate
- A copy of the ISO 9001 and EN/ISO 13485 certificates
- The completed form
- A copy of the declaration of conformity
- A copy of the Design Examination certificate
- A copy of the CE certificate
- A copy of the ISO 9001 and EN/ISO 13485 certificates
- The completed form
- A copy of the declaration of conformity
- A copy of the Design Examination certificate
- A copy of the CE certificate
- A copy of the ISO 9001 and EN/ISO 13485 certificates
- The completed form
- A copy of the declaration of conformity
- The notification number provided by the competent authority
- A copy of the CE certificate (except for "other" IVDs and Class A non-sterile IVDs)
- A copy of the ISO 9001 and EN/ISO 13485 certificates
This number is used to make the link with the notification for placing on the market. Manufacturers or authorised representatives of manufacturers of Class I medical devices must submit a notification for placing on the market to the FAMHP. This number also enables us to process the file more quickly.
- If the manufacturer or authorised representative has its registered place of business in Belgium: no, you cannot obtain a certificate of free sale until the notification of the placing on the market of class I medical device is in order (in accordance with Article 10 of the Royal Decree of 18 March 1999). The same applies to the IVD (Article 5 of the Royal Decree of 14 November 2001)
- If the manufacturer or authorised representative has its registered place of business in another Member State: you will receive the certificate of free sale provided that you have supplied us with proof of notification to the competent authority by the manufacturer or authorised representative.
To apply for a certificate of free sale under the Directiveyou must be registered in our web portal as an "exporter". You cannot apply for a certificate of free sale under the Regulation.. You must contact the manufacturer or its authorised representative so that they can submit an application to their competent authority.
For paper processing, please send only one copy.
A declaration of conformity is drawn up by the manufacturer and must contain the name of the medical device or the generic term and confirm the device's compliance with the essential requirements of the directive associated with the device (93/42/EEC for medical devices; 98/79/EEC for in vitro diagnostic medical devices; 90/385/EEC for active implantable medical devices; Regulation 2017/745 for medical devices; Regulation 2017/746 for in vitro diagnostic medical devices). This declaration concerns one or more manufactured medical devices that are clearly identifiable by product name, product code or other unambiguous reference. The declaration is kept by the manufacturer. It must also be dated and signed by the manufacturer, with identification of the signatory.
The CE marking certificate is issued by a notified body in the name of the manufacturer. The name and address of the manufacturer indicated on the certificate of free sale must correspond to those given on the CE certificate. The details of the notified body indicated on the certificate of free sale must also correspond. The CE marking certificate must be the certificate covering the medical devices in the certificate of free sale.
For certificate fees, please refer to ourFees page.
Yes, the fee covers the time and effort spent on the file.
No. The FAMHP only certifies free sales certificates processed electronically.
No.
Yes.
No, you must submit a new application.
No. It is up to the applicant to ensure that the certificate of free sale is required.
A certificate of free sale can include several medical devices, provided they belong to the same class and are listed on the same CE marking certificate. However, limits are set for each type of device. Certificates for medical devices (MD) and active implantable medical devices (AIMD) can cover 10 different devices. For certificates for in vitro diagnostic medical devices (IVD), the limit is 40 devices.
A certificate of free sale is granted for a single importing country. If you wish to export medical devices to several countries, you must submit several applications.
A certificate of free sale remains valid as long as the attached documents are valid and no information on the form has changed.
The certificate number is assigned by the administration.
No.