A national STA relating to aspects of the research and development of the aforementioned health products can be requested within FAMHP at any development stage. However, the national STA procedure focuses mainly on health products in (pre-)clinical development in order to provide proactive guidance to innovators and ensure that these products are developed in accordance with current regulatory requirements and standards before they are placed on the Belgian/European market.
In the event that the FAMHP is of the opinion that the product for which advice is formally requested falls outside the areas of competence of the FAMHP, the applicant will automatically be transferred to the authority in Belgium deemed to be competent for this type of product (e.g. FPS Public Health, Food Chain Safety and Environment). Consequently, the STA application will be declared invalid during the validation process by the National Innovation Office and Scientific-Technical Advice Unit.
As set out in the Royal Decree of 12 May 2024 relating to STA on health products and advice relating to the status and classification of a product, the dates on which the new national STA procedures enter into force are as follows.
• STA procedures on in vitro medical devices (IVDs) and human body material (HBM): 20 June 2024
• STA procedures on medical devices: 1 January 2025
Questions regarding the classification of a medical device or IVD product fall within the scope of the Borderline STA procedure. For detailed information about this procedure please visit the Borderline STA webpage.
If you are uncertain about the regulatory status of your product, please refer to the Borderline Products webpage for further guidance.