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Medical devices regulatory systems at country levelSierra Leon
World Bank income group: Low incomeLegal
Legal framework: Yes
Authorizing legislation: The Pharmacy and Drugs Act, No 58 of 13th December
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What is medical devices regulatory systems?
Medical devices regulatory systems are the set of rules and regulations put in place by governing bodies to ensure the safety, effectiveness, and quality of medical devices.
Who is required to file medical devices regulatory systems?
Manufacturers, distributors, and importers of medical devices are required to file medical devices regulatory systems.
How to fill out medical devices regulatory systems?
Medical devices regulatory systems should be filled out according to the guidelines provided by the regulatory authority, including information on the device, its intended use, manufacturing processes, and risk assessments.
What is the purpose of medical devices regulatory systems?
The purpose of medical devices regulatory systems is to protect public health by ensuring that medical devices are safe, effective, and of high quality before they are introduced to the market.
What information must be reported on medical devices regulatory systems?
Information that must be reported on medical devices regulatory systems includes device specifications, risk assessments, clinical data, labeling, and post-market surveillance plans.
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