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This application is a service of the Singapore Government.

Health Sciences Authority

Overview

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About Medical Devices Regulations

In Singapore, medical devices are regulated by the HSA to safeguard public health and safety. They are defined as health products which have a physical or mechanical effect when used on human bodies and are used to: 

  • Diagnose, alleviate or treat a medical condition
  • e.g. X-ray machines, contact lenses, artificial (prosthetic) knee

  • Measure or monitor functions of the body
  • e.g. blood pressure or blood sugar monitoring machines

*Products which are used to maintain or support general well-being, such as body toning equipment, magnetic accessories and massagers, are NOT medical devices and hence not regulated by HSA.

The laws which govern medical devices sold in Singapore are the Health Products Act (Act) and Health Products (Medical Devices) Regulations. All product owners are required under these laws to register their medical devices and obtain the dealer’s licence with HSA before selling or dealing with them.  

Below is a typical medical device regulation cycle:

Figure5_4 edit Before Application
During ApplicationAfter Approval of Application

Quick Guide

Download our quick guide to medical device product registration and dealers licencing

Before Application
Application

CRIS account allows companies to authorise their employees or third party service providers to access HSA’s E-services (e.g. MEDICS) to perform electronic transactions on behalf of the companies.

After Approval of Application

Reporting of:

 

 

Frequently Used Links

RegBasics

Useful Information

Guidances
Read these documents for detailed instructions on the various steps on medical devices registration

Processing timelines 
HSA’s review timelines for product registration and change notification applications

Fees 
Registration, retention, amendment, Dealer’s Licence and other fees


AppTools

E-services and forms

Medical Device Information Communication System (MEDICS) 
Carry out transactions with Medical Devices Branch (MDB) and view medical device information online

Singapore Medical Device Register (SMDR) 
Search for registered medical devices in Singapore

Class A Medical Device Register 
Search for Class A medical devices in Singapore

Health Product enquiry form
Download this form for any further enquiries on product and risk classification of medical devices

Grouping enquiry form
Download this form for any further enquiries on the grouping of medical devices for registration


Updates

Regulatory Updates

Latest News 
Regulatory updates, industry briefings and consultations

Field Safety Notices (FSN) 
Field Safety Notices submitted for FSCAs reported to HSA

Medical Devices Advisories
For healthcare professionals, industry and consumers