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Medical Devices  - Singapore

Compliance Services

Where would you like to market your products?

Medical devices in Singapore are regulated under the Health Products Act and its Health Products (Medical Device) Regulation, overseen by the Health Sciences Authority (HSA). Medical device dealers must be registered with Accounting and Corporate Regulatory Authority (ACRA). 

  • There are 2 possible applications which can be done simultaneously: 

    1. Product registration: to obtain marketing clearance for the product’s import and supply in Singapore.

    2. Dealer’s license: obtain clearance to engage in the manufacture, import and/or wholesale of medical devices in Singapore.

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  • Successful applicants will receive a certification and be listed on the Singapore medical device register.

Medical Device Definition

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

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

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

Product Registration

  • Determine the risk classification of the medical device, either class A, B, C or D. Medical devices in class A do not require product registration. The risk classification of each medical device depends on the design and claims made by the product owner and on its intended purpose.

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  • Classification of general medical devices are governed by 16 classification rules, and In Vitro Diagnostic Devices are governed by 7 classification rules. 

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  • Each device registration is done via a specific evaluation route which depends on:

    1. Risk classification of the device

    2. Number of prior approvals given by our overseas reference regulatory agencies

    3. Duration of the device’s safe marketing history

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  • Evaluation routes:

    1. Full, Abridged, Expedited, Immediate

    2. Priority review route: applies 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.​

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Scheme 1: Designed and validated for an unmet clinical need for one of the 5 healthcare areas – cancer, diabetes, ophthalmic diseases, cardiovascular diseases, and infectious diseases.

Scheme 2: The medical device does not meet the above two criteria.

SG medical devices table - evaluation routes, condition, fees and turnaround time.png

*Reference regulatory agencies: Australia Therapeutic Goods Administration (TGA), European Union Notified Bodies (EU NB), Health Canada (HC), Japan Ministry of Health, Labor and Welfare (MHLW), US Food and Drug Administration (US FDA)

Dealer’s license application

  • Although class A medical devices are exempted from product registration, a dealer’s license application is still needed, along with the completion of the Class A Exemption List in MEDICS.

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  • Dealer Licensing

    1. Manufacturer’s license: Manufacture of medical devices in Singapore

    2. Importer’s License: Import of medical devices into Singapore

    3. Wholesaler’s License: Wholesale of medical devices in Singapore (including export)

SG medical device dealer license requirements.png

Fees and turnaround time for dealer's license

  • New application: $1,030 & 10 days

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  • Annual renewal: $1,030 & 10 days

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  • Dealer's license amendment: $155 & 10 days

* Licenses are valid for 12 month from the date of license approval. Renewal of licenses must be submitted and processed before the expiry.

Reference: HSA website, https://www.hsa.gov.sg/medical-devices/registration

definition
Product registration
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