Singapore Medical Device Regulations

Agency

Health Sciences Authority (HSA) regulates medical devices in Singapore.

Medical Device Definition

Medical Devices are health products that 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.

Medical Device Classification System

International Classification	Risk Level	Examples
Class A	Low risk	Wheelchairs or tongue depressors
Class B	Low to Moderate Risk	Hypodermic needles or suction equipment
Class C	Moderate to High Risk	Ventilators or bone fixation plates
Class D	High risk	Heart valves or implantable defibrillators

Approval Process

Classification	Approval procedure
Class A	Product registration is not required for Class A medical devices, but the completion of the Class A Exemption List in MEDICS is necessary when applying for a license.
Class B	For Class B, there are three evaluation routes for registration: 1.Class B Full Registration 2.Class B Abridged Registration 3.Class B Immediate Registration
Class C	For Class C, there are four evaluation routes for registration: 1.Class C Full Registration 2.Class C Abridged Registration 3.Class C Expedited Registration 4.Class C Immediate Registration
Class D	For Class D, there are three evaluation routes for registration: 1. Class D Full Registration 2. Class D Abridged Registration 3. Class D Expedited Registration Note: Combination Devices are also regulated as Class D medical devices, following two evaluation routes: 1. Class D with a registrable drug in a secondary role: Full registration 2. Class D with a registrable drug in a secondary role: Abridged Registration
Full Registration: Approval beforehand is not required from any of the regulatory agencies HSA refers to overseas. Abridged Registration: Obtaining approval from a minimum of one of the regulatory agencies HSA refers to overseas is necessary. Immediate Registration (Class C and Class D): Approval from one or two regulatory agencies, with a marketing history of 3 years, no safety issues or prior rejections from any regulatory agency. Expedited Registration (Class B): Approval from one or two regulatory agencies, with a marketing history of 3 years, no safety issues or prior rejections from any regulatory agency.

Additional Information

Approval timeline

Depends on the class of the device and the evaluation route.
Priority Review Scheme: Medical device manufacturers have the option to register and market their products more quickly through the Priority Review System for Class B, C and D devices that are submitted under the full evaluation route and excludes Class D devices with a registrable drug in a secondary role.

License validity period

Never expires if annual retention fee is paid (every 12 months)

Fees

Fees	Class B (SG$)	Class C (SG$)	Class D (SG$)	Class D with a Registrable Drug (SG$)
Application Fee	$530	$530	$530	$530
Immediate Route Fee	$950	$3,180	N.A.	N.A.
Expedited Route Fee	N.A.	$3,180	$5,730	N.A.
Abridged Route Fee	$1,910	$3,710	$6,050	$10,400
Full Route Fee	$3,710	$6,050	$11,800	$75,400

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