Medical Device Regulation Resources
Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat diseases. Strict rules ensure patient safety and treatment efficacy. However, compliance is...
United States
Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on the latest standards helps businesses avoid costly violations and improve the efficacy and safety of...
HSA
The article provides a general overview of the critical points associated with the registration procedures for healthcare products intended to be marketed and used in Singapore.
HSA
The new article provides an overview of the medical device registration process in general. Also, it describes in detail the approach to be followed for registration of Class A and B products.
HSA
The new article describes the regulatory requirements concerning high-risk products – Class C and D medical devices.
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