Singapore Medical Device Regulations

Regulatory Agency

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

Medical Device Definition

Medical Devices: 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.

Active Medical Device: means any medical device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy, but does not include any medical device intended to transmit energy, substances or other element between that medical device and a patient without any significant change to that energy. substance or element.

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

Regulatory 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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