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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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