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This application is a service of the Singapore Government.

Health Sciences Authority

Medical Devices Advisories

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Advisory to Healthcare Professionals

How are medical devices regulated in Singapore?

Medical devices are regulated under the Health Products (Medical Devices) Regulations of the Health Products Act (HPA).

Under the HPA, medical devices are subject to product registration. The objective is to ensure that products marketed in Singapore meet desired standards of safety, quality and performance.

Certain low risk medical devices are exempted from product registration. The list of all low risk medical devices that are exempted from product registration can be accessed here.

Medical devices that are registered with the Health Sciences Authority (HSA) are listed in the Singapore Medical Device Register (SMDR).

Medical devices that have been submitted for product registration before certain stipulated deadlines but have not undergone the complete evaluation are placed on the Transition List. Products on the Transition List can continue to be supplied in Singapore.

In addition to product registration, importers, wholesalers and manufacturers of medical devices are required to be licensed under the HPA. The objective of licensing of dealers is to ensure that such dealers possess the necessary quality systems to allow traceability and timely reporting and recall of unsafe products.

What are the different risk classes of medical devices and how are they divided into the risk classes?

The risk presented by a particular medical device depends substantially on its intended purpose and its inherent risk – example the degree of invasiveness and its contact duration with the body.

The classification of each device also depends on the claims made by the manufacturer and on its intended use. While the provision of the general rules and illustrative examples below are useful, it must be emphasised that the actual classification of a particular device must be considered individually, taking into account of its design and intended use.

An implant intended to remain in the body for more than 30 days would be Class C (e.g. orthopaedic implants such as hip implants) but these would become a high risk Class D device if they are used in direct contact with the heart and central nervous system (e.g. heart valves, coronary stents). Other devices that are not implants and are used in the body for less than 30 days would typically be Class B device (e.g. tracheal tubes, urinary catheters).

Active (connected to external energy source) medical devices intended for use in critically ill patients (e.g. vital signs monitor in ICU, external defibrillators and pace makers) are Class C while those that come into contact with the heart (e.g. implantable defibrillators and pacemakers) would be Class D. Class B active devices would typically include hearing aids, ultrasound imaging devices and blood pressure monitors.

The risk class is also determined by certain device specific characteristics. For e.g. all absorbable medical devices (e.g. absorbable sutures) would be Class D. Radiology devices that emit ionising radiation or other hazardous radiation, contraceptive devices (e.g. condoms) and blood glucose meters would be Class C. Other common devices such as pregnancy test kits and contact lens would be Class B.

Further guidance regarding the classification is attached here for your reference.

How do I import and supply an unregistered medical device?

There are exceptions from product registration provided under the Health Products (Medical Device) Regulations, to facilitate access to unregistered medical devices. Importation and supply of such unregistered medical devices can be cleared through one of the Authorisation Routes.

The key special authorisation routes that are relevant to healthcare professionals include:

  • GN-26: Authorisation Route for Supply on Named-Patient Basis
  • GN-27: Authorisation Route for Supply on Request of PHMC-Licensed Facility
  • GN-29: Authorisation Route for Supply for Non-Clinical Purpose

Other authorisation routes available are:

  • GN-28: Authorisation Route for Export of Unregistered Medical Devices
  • GN-30 (CR): Authorisation Route for Import on Consignment Basis (Consignment Registered Route)
  • GN-30 (CUR): Authorisation Route for Import on Consignment Basis (Consignment UnRegistered Route)

Please click here for more information on these authorisation routes and application forms.

For queries and feedback regarding access to medical devices, please contact the dedicated healthcare professionals hotline at 63045861 during office hours from 8.30 am to 6.30pm (Mondays to Fridays).

Why can't you “rubber stamp” CE marking and FDA certification? Why is there a need to “re-invent the wheel”?

We take into account approvals from EU (CE Mark) and FDA, applications for devices approved by EU and FDA qualify for the abridged evaluation. This is a shortened review route and applications are subject to lower fees. Further guidance on details of the abridged route is attached here for your reference.

Advisory to Industry

How are medical devices regulated in Singapore?

Medical devices are regulated under the Health Products (Medical Devices) Regulations of the Health Products Act (HPA).

Under the HPA, medical devices are subject to product registration. The objective is to ensure that products marketed in Singapore meet desired standards of safety, quality and performance.

Certain low risk medical devices are exempted from product registration. The list of all low risk medical devices that are exempted from product registration can be accessed here.

Medical devices that are registered with the Health Sciences Authority (HSA) are listed in the Singapore Medical Device Register (SMDR).

Medical devices that have been submitted for product registration before certain stipulated deadlines but have not undergone the complete evaluation are placed on the Transition List. Products on the Transition List can continue to be supplied in Singapore.

In addition to product registration, importers, wholesalers and manufacturers of medical devices are required to be licensed under the HPA. The objective of licensing of dealers is to ensure that such dealers possess the necessary quality systems to allow traceability and timely reporting and recall of unsafe products.

What are the different risk classes of medical devices and how are they divided into the risk classes?

The risk presented by a particular medical device depends substantially on its intended purpose and its inherent risk – example the degree of invasiveness and its contact duration with the body.

The classification of each device also depends on the claims made by the manufacturer and on its intended use. While the provision of the general rules and illustrative examples below are useful, it must be emphasised that the actual classification of a particular device must be considered individually, taking into account of its design and intended use.

An implant intended to remain in the body for more than 30 days would be Class C (e.g. orthopaedic implants such as hip implants) but these would become a high risk Class D device if they are used in direct contact with the heart and central nervous system (e.g. heart valves, coronary stents). Other devices that are not implants and are used in the body for less than 30 days would typically be Class B device (e.g. tracheal tubes, urinary catheters).

Active (connected to external energy source) medical devices intended for use in critically ill patients (e.g. vital signs monitor in ICU, external defibrillators and pace makers) are Class C while those that come into contact with the heart (e.g. implantable defibrillators and pacemakers) would be Class D. Class B active devices would typically include hearing aids, ultrasound imaging devices and blood pressure monitors.

The risk class is also determined by certain device specific characteristics. For e.g. all absorbable medical devices (e.g. absorbable sutures) would be Class D. Radiology devices that emit ionising radiation or other hazardous radiation, contraceptive devices (e.g. condoms) and blood glucose meters would be Class C. Other common devices such as pregnancy test kits and contact lens would be Class B.

Further guidance regarding the classification is attached here for your reference.

How do I import and supply an unregistered medical device?

There are exceptions from product registration provided under the Health Products (Medical Device) Regulations, to facilitate access to unregistered medical devices. Importation and supply of such unregistered medical devices can be cleared through one of the Authorisation Routes.

The purpose of these routes is to facilitate access to unregistered medical devices. The key special authorisation routes that are relevant to industry include:

  • GN-26: Authorisation Route for Supply on Named-Patient Basis
  • GN-27: Authorisation Route for Supply on Request of PHMC-Licensed Facility
  • GN-29: Authorisation Route for Supply for Non-Clinical Purpose

Other authorisation routes available are:

  • GN-28: Authorisation Route for Export of Unregistered Medical Devices
  • GN-30 (CR): Authorisation Route for Import on Consignment Basis (Consignment Registered Route)
  • GN-30 (CUR): Authorisation Route for Import on Consignment Basis (Consignment UnRegistered Route)

Please click here for more information on these authorisation routes and application forms.

For queries and feedback, please contact the Medical Device Branch hotline at 68663560 or 68663566 during office hours from 8.30 am to 6.30pm (Mondays to Fridays).

How do I make changes to a pending application?

Changes to medical devices with ongoing product registration or Change Notification will be allowed to be included in the pending application. The criteria for making such changes are:

  • the application is in “Pending Verification” stage in MEDICS, and
  • the change is within the list of changes in GN-21 Guidance on Change Notification.

To update the dossier, please email the job reference number of the application and your request to hsa_md_info@hsa.gov.sg. There will be no additional charge for this addition to a pending application if it meets the 2 criteria.

Where can I find the guidance notes for medical device registration and dealers licensing?

Please click here for a quick guide that provides a step by step guidance on the actual process of medical device product registration and dealers licensing.

Please click here to access the regulatory guidances for medical device registration and dealers licensing.

What are the different turnaround times (TAT) needed to register a device?

Different risk classes of medical devices need different depths of review. There are also more documents to be reviewed for the higher risk class, this results in the differing turnaround times.

Please refer the GN15 Guidance on the details of the TAT abridged route.

What are the different fees needed to register a device?

Please click here to access the fees information.

What does the regulatory fee cover?

The regulatory fee covers the screening and evaluation process of the application for the medical device registration. This registration fee is payable only once for the product to be registered, until the company takes it off the SMDR.

Advisory to Patients and Consumers

What are medical devices?

Medical devices are products that are intended for use in humans for health related purposes such as diagnosis, prevention and treatment of diseases.

Examples of medical devices are:

  • Stents
  • Pacemakers
  • Orthopaedic implants

Please click here for more information on what is a medical device.

Why are medical devices regulated?

Medical device regulations is in place to ensure that products marketed in Singapore meet desired standards of safety, quality and performance.

How are medical devices regulated?

Medical devices are regulated under the Health Products (Medical Devices) Regulations of the Health Products Act (HPA). Under the HPA, medical devices are subject to product registration. The objective is to ensure that products marketed in Singapore meet desired standards of safety, quality and performance.

Certain low risk medical devices are exempted from product registration. The list of all low risk medical devices that are exempted from product registration can be accessed here.

Medical devices that are registered with the Health Sciences Authority (HSA) are listed in the Singapore Medical Device Register (SMDR).

Medical devices that have been submitted for product registration before certain stipulated deadlines but have not undergone the complete evaluation are placed on the Transition List. Products on the Transition List can continue to be supplied in Singapore.

In addition to product registration, importers, wholesalers and manufacturers of medical devices are required to be licensed under the HPA. The objective of licensing of dealers is to ensure that such dealers possess the necessary quality systems to allow traceability and timely reporting and recall of unsafe products.

How do I find out more about safe use of medical devices?

HSA has developed a consumer leaflet to explain the basic controls, keep consumers informed of developments in the medical device market, and to provide tips for the safe use of medical devices.

Click here to read the consumer leaflet.

For queries and feedback, please contact the Medical Device Branch hotline at 68663560 or 68663566 during office hours from 8.30 am to 6.30pm (Mondays to Fridays).

If I have any problems/issues with the medical device that I have, how do I report it to HSA?

Please email to HSA at HSA_MD_INFO@hsa.gov.sg

Medical Device Press Releases and/or Product Advisories

Press Releases and/or Product Advisories related to medical devices that have been issued by the Medical Device Branch.

Download.IconPdf22 July 2015 - Clearblue Digital OvulationTest Recall
File Size: (167 Kb)

Download.IconPdf24 August 2011 - Bayer Contour TS 10, 25-Count Test Strip Vial Recall
File Size: (289 Kb)

Download.IconPdf20 July 2011 - Counterfeit Contact Lenses Sold in Local Optical Shops
File Size: (131 Kb)

Download.IconPdf02 November 2010 - Update on Acuvue TruEye Contact Lens Recall
File Size: (117 Kb)

Download.IconPdf20 August 2010 - Acuvue TruEye Contact Lens Recall
File Size: (39 Kb)

Download.IconPdf24 December 2010 - Abbott Medisense Optium Blood Glucose Test Strips Recall
File Size: (468 Kb)

Download.IconPdf20 October 2008 - Hot/Cold Pack Recall
File Size: (3671 Kb)

Consumer Advice on Use of Contact Lens

For consumer advice on contact lens use, please click on this link.

Understanding Medical Devices

Click here to read the article on "Understanding Medical Devices".