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Health Sciences Authority

Regulatory overview

Understand the scope of regulations on medical devices in Singapore.

Last updated 28 May 2026

What is a medical device?

Medical devices are health products which have a physical or mechanical effect when used on human bodies. These devices are used to:

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

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

Products used to maintain or support general well-being without specific medical claims, such as body toning equipment, magnetic accessories and massagers, are not medical devices.

Is my product a medical device?

Answer a few questions to find out if your product is considered a medical device in Singapore.

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Legislation

We regulate medical devices in Singapore under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010.

Scope of regulation

We require companies to obtain a dealer's licence before manufacturing, importing or supplying medical devices. All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from product registration, or under specific conditions as approved by us.

Flowchart showing device registration and dealer licensing leading to importing or wholesaling devices, followed by four duties including notifications and reporting.

Device registration

You must register your medical device before you can supply it in Singapore. Registration requirements will differ depending on your device's risk classification and the evaluation routes.

Dealer's licensing

All medical device dealers will need to apply for a dealer's licence before you can import, manufacture and supply your devices in Singapore. HSA will assess if you meet Good Distribution Practice requirements before issuing your licence.

Please refer to our Quick Guide for an overview of medical device product registration and licensing.

Notify changes for registered devices

You must notify HSA prior to implementing changes to your medical device. The changes include technical changes, review changes, administrative changes, notification changes and changes arising from Field Safety Corrective Actions.

Advertisement and sales promotion

It is the responsibility of the advertiser to ensure compliance with legislation and guidelines for advertisements and promotions of medical devices.

Adverse Events (AE) reporting

All companies dealing in medical devices including importers, manufacturers, suppliers and registrants are required to report adverse events of their products.

Field Safety Corrective Actions (FSCA) reporting

If your device poses a health risk to users, you must inform HSA, take corrective actions, and send out communications to the device users, healthcare professionals and the public.