Regulative problems with medicines and medical devices
Reporting a suspected problem with a medicine or medical device using the Yellow Card Scheme as soon as possible, Examples include a medicine causes side effects, someone’s injured by a medical device, either because its labelling or instructions aren’t clear, it’s broken or has been misused, a patient’s treatment is interrupted because of a faulty device, someone receives the wrong diagnosis because of a medical device, a medicine doesn’t work properly, a medicine is of a poor quality, medicine or medical device is fake or counterfeit. A rigorous approval process for medical devices is absolutely necessary. However, the process must be relevant for the safety and effectiveness questions that pertain to the product under review. The process must be efficient, streamlined, administratively consistent, predictable, and conducted with a sense of urgency. It must limit its scope of requirements to those data that are central to demonstrating safety and effectiveness. There are always more questions that could be asked of a new product. A patient-centered regulatory process prioritizes and limits questions to those that are essential to the demonstration of safety and effectiveness in the context of the disease.
- Medical devices Great Britain
- Medical devices cathode-ray oscilloscope and clinical studies
- Medical devices European country
- Innovations in physical drugs
- Unwanted effects/ side effects
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Regulative problems with medicines and medical devices Conference Speakers
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