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Staying compliant with regulatory requirements is crucial for medical device manufacturers and distributors. To support this, the Health Products Regulatory Authority (HPRA) has updated its process on 18 February 2025 for applying for Certificates of Free Sale (CFS). These changes aim to streamline applications, reduce errors, improve validation speed, and enhance overall processing times.
Key Updates to the CFS Process
The HPRA’s recent updates to the CFS application process include:
Unified Application Form: A single application form will be used for all CFS requests, simplifying the submission process
New Excel Device Schedule: Applicants must list all devices to be included on the certificate in a structured excel format, ensuring clarity and accuracy
Updated Certificate Template: The required information on the CFS has been revised to align with regulatory expectations and international standards
Dedicated Mailbox for Applications & Queries: A new, centralized email system has been introduced to handle CFS applications and related inquiries. You can access this mailbox via the HPRA’s contact form, selecting the “Medical Devices” category and the “Certificates of Free Sale” topic
How These Changes Benefit Applicants
These enhancements aim to reduce errors in applications by providing a more structured format, enable quicker validation checks for faster processing, and improve efficiency for both applicants and HPRA.
By implementing these updates, HPRA is committed to providing a smoother, more transparent application process for medical device manufacturers and exporters.
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