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This application is a service of the Singapore Government.

Health Sciences Authority

Overview

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The Medical Device Branch is entrusted with the responsibility of regulating medical device products placed on the Singapore market. Our objective is to safeguard public health and safety by implementing regulatory controls through a programme of pre-market assessment of devices, manufacturing controls and post-market vigilance. Medical Device Branch carries out a range of assessment and monitoring activities to ensure medical devices available in Singapore are of an acceptable standard in accordance to the Health Products Act and Health Products (Medical Devices) Regulations.

Click here to view the contact information.

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.

Frequently Used Links

RegBasics

Registration Basics

Regulatory Guidances
Guidance documents and draft guidance for consultation

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

Target Processing Timelines
Target turn-Around-Time (TAT) for product registration and change notification applications


AppTools

Application Tools

MEDICS
Carry out transactions with MDB and view medical device information online

Medical Devices Risk Classification Tool
To identify the risk classification of medical devices

SMDR
Search the Singapore Medical Device Register (SMDR)

Health Product enquiry form
Enquire about medical devices

Grouping enquiry form
Enquire about grouping of medical devices


Updates

Updates

Regulatory Updates
News updates, safety alerts on medical devices and guidance documents

Medical Devices Advisories
For healthcare professionals, industry and consumers


SafetyReporting

Safety Reporting

Field Safety Corrective Action Reporting
Guidance on submitting FSCA

Adverse Event Reporting
Reporting adverse events