Notification procedure for implants and invasive medical devices for long-term use

	Actuality
	04/05/2011	Upload of new notifications and modifications via xml
	30/04/2009	Notification procedure for implants: access to the application on line

Notification: condition for reimbursement

As of the 1^st of May 2009, a new legislation applies for the reimbursement of implants and invasive medical devices. This legislation prescribes a notification for implants with an EC-certificate.

Only the implants for which the condition of notification is fulfilled, may be subject to a contribution of the compulsory insurance.

The implants which are not notified, even though they are subject to the conditions of notification, cannot be billed to the beneficiaries. If the beneficiary is hospitalized, the implants will be entirely at the charge of the budget financial means of the hospital.

This notification does not assess the quality of the products already available on the market, but gives the compulsory insurance for health care the possibility to have an overview of all the implants that already exist on the market.

Application date and transition period

The notification procedure comes into effect on the 1^st of May 2009. From this date, a transition period of one year is considered in order to give the companies the necessary time to be able to notify the products already available on the market. During this period, the implants remain reimbursable according to the current system of reimbursement.

Which products are concerned?

The categories of products are established in the Royal Decree.

• Which products have to be notified? (Dutch – French)
• Which products don’t need to be notified? (Dutch – French)

Notification procedure

The companies introducing implants on the Belgian market will themselves notify their products in a national l data base.

Upload of new notifications and modifications via xml

Instead of introducing one by one the new implants and the modifications to implants in the online application and , you can also upload them in group.

Presentation for the companies

The 29th of April and the 8th of May 2009, the NIHDI organized an information session concerning the notification procedure to be attended by companies (PDF - 390 KB).

Classification

A notified product must be categorized. The classification list, and all the modifications which have been made to it, can be consulted on Internet site via the link « Publication and Classification List ».

Notification number FAMHP

One of the elements needed for the registration is (are) the notification number(s) assigned to suppliers of medical devices by the Federal Agency for Medicines and Health Products (FAMHP). If that (these) number(s) hasn’t (haven’t) been assigned yet to the applicant because his file is still pending at the FAMHP, the supplier receives a temporary access. This will allow him to manage his registration data and to notify his implant(s).

Mandate

The person responsible for the company can through this form (Word - 27 KB - PDF - 21 KB) grant a mandate in order to perform, on his behalf, all acts and deeds necessary within the scope of the notification.

State of affairs

The information will regularly be updated so that you can keep track of the evolution of this dossier by means of the site.

Legal framework

• Article 35septies, § 1 of the Belgian Law concerning the compulsory insurance for health care and benefits, coordinated on July 14th 1994 (Dutch – French)
  
  
• The Belgian Royal Decree executing article 35 septies, § 1 (PDF - 65 KB), with regard to the notification of implants and invasive medical devices for long-term use. (Dutch – French)

Contact

• mail to:
• Tel: 02/739.77.13
• write to:
  • INAMI-RIZIV-NIHDI
    Dienst voor Geneeskundige Verzorging – Service des soins de santé
    Sectie Implantaten – Section Implants
    Lokaal-local T541
    Avenue de Tervueren – Tervurenlaan 211
    1150 Brussels