Guidance on the Reporting of Adverse Events for Medical Devices
This document is applicable to all persons who register, manufacture, import, and supply medical devices in Singapore. Persons who register, manufacture, import, and supply medical devices in Singapore shall also be referred to as dealers of medical devices in this document.
Medical Device Guidance on Clinical Evaluation
The primary purpose of this document is to provide product owners with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure before placing a medical device on the market as well as to support its ongoing marketing.
Guidance on Change Notification for Registered Medical Devices
Medical devices undergo changes as part of their product life cycle. This guidance document is intended to aid registrants in determining whether a Change Notification must be submitted for a medical device registered on the Singapore Medical Device Register (SMDR). Under the Health Products (Medical Devices) Regulations 2010 (Regulations), registrants are required to notify the changes concerning registered medical devices to the Authority.
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