Singapore

11/01/2022

Medical Device Guidance on the Declaration of Conformity This document provides guidance to assist a product owner in the preparation of a Declaration of Conformity (DOC) to Singapore’s regulatory requirements.

11/01/2022

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.

11/01/2022

Guidance on Complaint Handling of Medical Devices This document provides guidance for the handling of complaints related to medical devices.

11/01/2022

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.

03/07/2023

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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