Comprehensive Guide to Medical Device Registration in Belgium: FAMHP Regulations, Requirements, and Procedures.
Federal Agency for Medicines and Health Products, FAMHP
The Federal Agency for Medicines and Health Products (FAMHP) is a Belgian public interest organization established in 2006 under the category A law. Its mission is to ensure the quality, safety, and efficacy of medicines for human and veterinary use, including homeopathic and herbal medicines, pharmacy-made and officinal preparations, and health products like medical devices, accessories, and raw materials.
The FAMHP also manages operations involving blood, cells, and tissues. Its vision and ambition are centred around six key factors: recognition at national, European, and global levels, building partnerships with the healthcare sector, executing core responsibilities professionally, providing optimal public information, promoting cross-functional cooperation, and establishing a culture of continuous learning.
The FAMHP serves as the competent authority in Belgium for ensuring the quality, safety, and efficacy of medicines and health products, overseeing their development and use in clinical settings.
https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/legislation
Class I, IIa, IIb and III
The FAMHP charges a registration fee for all medical devices, which ranges from €37.50 to €8982 depending on the class of the device and the type of conformity assessment required.
5 Years
All labels and instructions for use must be provided in Dutch, French, and German
Before placing a medical device into the market.
The Belgium-based Pharmacovigilance Center (BCPH) oversees the coordination of various tasks related to pharmacovigilance. BCPH is a constituent of the European pharmacovigilance network known as Eudravigilance. Pharmacovigilance collaboration among the various Member States in the European Economic Area occurs through the activities of the Pharmacovigilance Working Party.
Creating, evaluating, and sustaining Risk Evaluation and Mitigation Strategies (REMS) while helping through submission channels Developing personalized protocols for categorizing safety risks and implementing individualized risk management approaches Analyzing potential risks and identifying gaps in information, then generating reports that propose methods for risk management.
Executing additional measures, which encompass Post-Authorization Safety Studies (PASS), involving the creation of educational materials, observational investigations, and focused follow-up questionnaires. Effectively communicate risks through labeling methods, such as the Summary of Product Characteristics (SmPC) and patient information leaflet (PIL).
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.