Health Science Authority

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.


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


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 


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Guidance documents and draft guidance of consultation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
Best viewed using Internet Explorer 7.0 and above. | Privacy Statement | Terms of Use | HSA Data Protection Policy | Rate Our Website
Health Sciences Authority © 2007-2011. All Rights Reserved.