Belgian Federal Agency Updates Clinical Investigation Submission Process
The Belgian Federal Agency for Medicines and Health Products (FAMHP) has released new guidance outlining the submission process for clinical investigations aligned with the Medical Device Regulation (MDR). The guidelines offer essential clarity on the national perspective for submitting clinical investigation documents in Belgium.
Highlights of the New Guidelines:
- The guidance is specifically tailored to ensure alignment with the requirements of the MDR.
- It provides detailed instructions and processes for clinical investigation submissions to better serve medical device companies, regulatory affairs professionals, and clinical researchers.
- The document addresses Belgium’s national submission requirements within the framework of the MDR.
- The guidelines are set to become effective starting January 2025, giving stakeholders ample time to familiarize themselves with the updated procedures.
Download the new guidelines
Medical device companies and clinical researchers conducting investigations in Belgium are encouraged to review the document thoroughly to ensure compliance and streamlined processing of future submissions.
For more information, visit FAMHP’s official website or consult with a regulatory expert to align your processes with the upcoming changes.
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