Belgium Medical Device Registration

Comprehensive Guide to Medical Device Registration in Belgium: FAMHP Regulations, Requirements, and Procedures.

Regulatory Authority

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.

Link for Regulatory Authority

https://www.famhp.be/en/famhp

Local Regulation

• Royal Decree of April 28, 2021(link is external) – Royal Decree modifying and withdrawing various provisions on medical devices;
• Royal Decree May 12, 2021(link is external) – Royal Decree implementing the Law of December 22, 2020, on medical devices;
• Royal Decree May 18, 2021(link is external) – Royal Decree on the clinical examination of medical devices.
• EU MDR 2017/745

https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/legislation

Classification of Medical Devices

Class I, IIa, IIb and III

Listing or Registration Requirements

• A notification for any clinical investigations being performed must be submitted using a form. Be careful, a new application form must be used for each separate device
• Three copies of the investigation file must be sent as appendices to the completed form. The investigation file must be accompanied by the payment of 8982€ (include USD equivalent here), no matter the classification of the device.
• To obtain a Free Sale Certificate, the completed submission must have the following documents:
  • A declaration of conformity;
  • A copy of the CE certificate (if applicable);
  • A copy of the ISO 9000 certificate and the EN / ISO 13485 certificate for the manufacturer (if applicable).

Documents Required for Registration

• Data enabling one to identify the product (description, instructions for use, brochure of the investigator, etc.)
• The program of investigation, indicating the objective, the technical and scientific justifications, the scope of the study, and the number of devices wanting to market
• The opinion of the Ethical Committee and the aspects considered in that opinion
• The name of the doctor or qualified person conducting the study
• The place and probable duration of the study
• The declaration showing that the device meets the essential requirements (except for those aspects covered by the clinical study) and that every precaution has been taken to protect the health and safety of the patients
• The document for patient consent; this document must be written in the language of the patients (i.e., French, Dutch, or German).
• The preferred submission format of the dossier is CD-ROM format.

Registration Timeline

• Class I devices – 4-6 weeks
• For the other classes, it depends on the contract with the notified body and the type of device.

Registration Fee

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.

License Validity

5 Years

Special Labelling Requirements

All labels and instructions for use must be provided in Dutch, French, and German

Who should make this communication?

• Manufacturer
• Authorized Representative

When to make this communication?

Before placing a medical device into the market.

Pharmacovigilance Center Belgium (CBPH)

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.

Risk Management Plan

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).

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk