Medical Device Safety: New Rules for Remanufacturers and Users
This act introduces new rules for repairing and modifying used medical devices to enhance patient safety. This means companies performing such activities will need to meet stricter requirements, giving citizens greater confidence in the quality and safety of medical equipment.
Key points
The act clearly defines "remanufacturing" of medical devices, including changes that could affect their performance or safety.
Companies engaged in remanufacturing medical devices will be required to register and be inspected, increasing oversight of their operations.
Authorities will conduct public awareness campaigns for citizens and the industry regarding the safety of remanufactured medical devices.
A system will be established for state authorities to report concerns about companies not complying with remanufacturing regulations.
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