The following FAQ is intended to guide you through the new registration procedure with the FAMHP as an operator in the medical devices sector.
- What is/are my activity/-ies?
- I have to register, how do I do this?
- Why do I have to register if I make available medical devices that are reimbursable by RIZIV/INAMI?
- Why am I invited to register if I am not legally obliged to do so?
- I don’t have to register but may I do so?
- How much does the notification of an activity cost?
- What about the future of the registrations?
Below, you will find the various possible activities. These activities may be found in the online applications when you register.
These activity definitions are based on the European definitions listed in the European regulations : 2017/745 for medical devices and 2017/746 for in vitro diagnostic medical devices. The definition of an exporter is based on the Royal Decree of 18 March 1999 on medical devices.
You may combine different activities. For example, you may act both as a manufacturer for the devices that you place on the market in your own name and as a distributor for devices placed on the market in the name of a third party.
In order to know whether or not you should register in our online applications, please be sure to state clearly which activities you undertake, according to the definitions below.
1. Manufacturer of medical devices
The definition of a manufacturer may be found in Article 33, § 1, 16°, of the Law of 15 December 2013 on medical devices:
16° “manufacturer”: the natural or legal person responsible for designing, manufacturing, packaging and labelling a device with a view to its placement on the market in their own name, whether these operations are performed by this same person or on their behalf by a third party. The term “manufacturer” also includes natural or legal persons who assemble, package, process, refurbish and/or label one or more prefabricated products and/or designate the purpose of a device with a view to its placement on the market in their own name. This rule does not apply to a person who, without being a manufacturer within the meaning of the first sentence, assembles or adapts devices already placed on the market, within the scope of their intended use, for an individual patient.
A manufacturer is an operator who places devices on the market under his own name, whether manufactured by himself or by a third party.
A manufacturer is therefore not considered to be a distributor if he makes his own products available on the market.
2. Authorised representative of a manufacturer of medical devices
The definition of an authorised representative or agent is mentioned in Article 1, § 2, 11° of the Royal Decree of 18 March 1999 on medical devices and of the Royal Decree of 14 November 2001 on in vitro diagnostic medical devices, and Article 1, § 2, 10° of the Royal Decree of 15 July 1997 on active implantable medical devices:
“agent”: any natural or legal person established in the Community who, having been expressly designated by the manufacturer, acts – and may be contacted by authorities and instances in the Community – on behalf of and in the name of the manufacturer, concerning the obligations that this decree imposes on the latter.
An authorised representative or agent acts in the name of the manufacturer according to the terms of the contract that binds them and must therefore follow the same instructions as are given to the manufacturer.
An authorised representative is considered to be a distributor if he distributes the devices that he represents.
If you import and make available medical devices in respect of which you operate as an authorised representative, please refer to the activity of importer or distributor of medical devices.
3. Distributor of medical devices
The definition of a distributor is mentioned in Article 33, § 1, 3° of the Law of 15 December 2013 on medical devices:
3° “distributor”: any physical or legal person that is part of the supply chain, other than the manufacturer or importer, who makes a medical device available on the European Union market.
A distributor is therefore an operator, other than the manufacturer and the importer, who makes medical devices available on the European Union market.
If you place medical devices on the market manufactured by you, or medical devices placed on the market in your own name, please refer to the activity of manufacturer of medical devices.
Note: the retailer is defined as:
4° “retailer”: a distributor who provides devices to consumers, i.e. any natural person who acquires or uses devices exclusively for private use.
This distinction only affects the fee and not the registration in our applications. If you are a retailer, please use the activity distributor of medical devices.
4. Exporter of medical devices
The definition of exportation is mentioned in Article 1, § 2, 16° of the Royal Decree of 18 March 1999 on medical devices, Article 1, § 2, 14° of the Royal Decree of 15 July 1997 on active implantable medical devices and Article 1, § 2, 21° of the Royal Decree of 14 November 2001 on in vitro diagnostic medical devices:
16° “exportation”: making a medical device available, for a consideration or free of charge, with a view to its distribution and/or use outside the Community market.
An exporter is therefore an operator who makes medical devices available outside the European market.
Moreover, an exporter has to apply for an export certificate depending on the country to which he exports.
5. Importer of medical devices
The definition of an importer is mentioned in Article 33, § 1, 17° of the Law of 15 December 2013 on medical devices:
17° “importer”: any natural or legal person established in the European Union who places a device from a third country on the European Union market.
An importer is therefore an operator who makes available medical devices from a country outside the European Union.
Visit our web page: you will find the relevant information to access this new IT tool. A dedicated access has been made available since 17 December 2017 (only in French and Dutch).
User manuals are available on this portal in order to guide you in registering your company:
In the My activity application, you must register under your own activity/-ies. An example for a manufacturer of medical devices is shown below.
When registering your activity/-ies, you should tick the class(es) of the devices that you place on the market.
For example, you manufacture:
- class I, class IIa, class III, IVD List A and IVD List B medical devices;
- class I and class IIa custom-made devices;
- class III systems and procedure packs.
For all questions relating to this new system, please contact email@example.com.
As a distributor, you will also be asked to fill in the information concerning the manufacturers and authorised representatives for the medical devices that you make available. This information must be registered in the My adress book application.
For each activity, you are invited to fill in an autocontrol form (self-monitoring form) in the My control application. This form can be used to perform a risk assessment. The My control application also enables you to communicate better with the inspector.
This self-inspection form is compulsory for distributors and exporters.
In accordance with Article 6 of the Royal Decree of 1 March 2009 implementing article 35septies, § 1 of the compulsory health insurance law, coordinated on 14 July 1994, related to the notification of implants and invasive medical devices for long-term use, the applicant must provide the notification number(s) allocated by the Federal Agency for Medicines and Health Products to distributors of medical devices.
The applicant is defined in Article 1, 5° of this same decree:
5° “applicant”: the company placing or having placed an implant on the Belgian market.
This means that the applicant must make himself known to the FAMHP in order to claim reimbursement for the medical devices that he makes available. Manufacturers and importers of invasive long-term medical devices and implants who are requesting reimbursement from RIZIV/INAMI must therefore register in the online applications.
We invite you to register voluntarily, even if you are not legally obliged to do so, in order to receive swift, targeted communications in connection with your registered activities. These communications may concern the future applications that we are developing, information on future regulation, topical trainings …
This registration will improve and speed up administrative procedures with the FAMHP.
Moreover, your registration will facilitate management of your inspections in the My control application. The frequency of these inspections is based on a risk analysis that takes into account various parameters such as registration in our applications and compliance with the guidance documents written by the sector that represents the activity. My control is also a tool for communication between you and the inspector responsible for your inspection.
Of course! You can still sign up on the FAMHP web portal, even if your company is based outside Belgium. By registering, you will be kept informed of FAMHP activities concerning medical devices.
Our applications are currently only available for operators based in the European Union. They are in the process of being revised so that operators based in a third country (outside the European Union), can access them.
Activity notifications are entirely free of charge.
Read more about the fees for notification of placing on the market (manufacturing) and for export licence applications.
In the short term
We are currently developing other applications in order to gather a maximum of information on your activities.
- Mes dispositifs médicaux: an application covering information on the medical devices that you manufacture and those that you distribute.
- Mes certificats d’exportation: an application that will be used to submit export certificate applications.
- Mes fabricants: an application that will be used by authorised representatives in order to provide complete information on manufacturers outside the European Union that they represent.
These applications will be released in 2018 and 2019. We will keep you informed of the various releases.
In the medium term
At European level, there have also been many changes since the publication of two new regulations on 5 May 2017:
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
We are currently in the transition phase.
The MDR will apply as of 26 May 2020; the IVDR as of 26 May 2022.
Moreover, the European Commission is currently working on a new database called MDR‑Eudamed.
This database will consist of six modules:
- Operators (manufacturers, authorised representatives and importers)
- Devices and UDI (Unique Device Identifier)
- Clinical trials and performance studies
- Vigilance data
- Market oversight
This database will be accessible to the competent authorities, the notified bodies, the industry and the general public. The aim of this database is to gather a maximum of information on the medical devices placed on the market in the European Union and increase market oversight in order to have more safe and effective medical devices available to the patient.