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Medical Devices

Medical devices are critical to the delivery of healthcare.

The term “Medical Devices”, as defined in the Health Products Act 2007, covers a wide range of medical instruments used in the treatment, mitigation, diagnosis or prevention of disease or abnormal physical condition.

Medical devices vary in complexity from simple products such as tongue depressors, surgical sutures and contact lenses to more complex devices such as implantable defibrillators, prosthetic heart valves and diagnostic imaging systems.

The applicant is reminded that, besides registration of the medical device under the Health Products Act, the supply and use of any medical device in Singapore should also comply with the requirements under other applicable legislations (e.g. Private Hospitals and Medical Clinics Act, Professional Acts*, Radiation Protection Act).

*Professional Acts include Medical Registration Act, Dental Registration Act and others.


Overview

Learn more about what is a medical device and the principles of classification of medical devices.


Regulatory Framework

Provisions of the Contact Lens Practitioners Act, Radiation Protection Act, Medicines Act and Implementation of regulatory controls.


Regulatory Updates

News updates, safety alerts on medical devices and guidance documents.


Medical Devices Advisories

For healthcare professionals, industry and consumers


SMDR

Search the Singapore Medical Device Register (SMDR)   


Fees and Charges

Registration, Retention, Amendment, Dealer's Licence and other Fees





MEDICS (Medical Device Information & Communication System)

 Carry out transactions with MDB and view device information online


Authorisation Routes


Transition List

Information on the Transition List (T-list) 


Other e-services and Forms

CRIS, Pre-submission consultation, Grouping enquiry





HSA Smart E-Guide

A step by step video guide on registration of medical devices 


FAQs


Regulatory Guidances

Guidance documents and draft guidance of consultation


TradeNet Controls

Import of medical devices in Singapore through TradeNet





Field Safety Corrective Action Reporting

Guidance on submitting FSCA


Adverse Event Reporting

How to report adverse events to MDB





Last updated on 04 Jun 2013 17:23:27
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