Medical Device Safety: New Reporting and Testing Rules.
This act introduces new requirements for medical device manufacturers to ensure device safety and cleanliness. Citizens can expect that medical devices they use will be more thoroughly checked, and manufacturers will have to report changes in design or cleaning instructions more quickly. This aims to increase confidence in medical equipment and improve health protection.
Key points
Medical device manufacturers must report design or reprocessing instruction changes before marketing them.
Manufacturers must report important safety communications about devices, even if directed to foreign healthcare providers.
New rapid assessment tests are introduced to ensure reusable devices are properly reprocessed, enhancing patient safety.
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