print small large

This application is a service of the Singapore Government.

Health Sciences Authority

Authorisation Routes

Overview of Supply

From 1 Jan 2012 onwards, with the exception of the following:

  • Class A medical devices (Non Sterile) exempted from product registration
  • Medical devices for clinical trials

          All other medical devices shall either have to be:

  • registered on SMDR, OR
  • cleared for import and supply through one of the authorisation routes,

          prior to their supply.

Authorisation Route Application Fees

Please refer to the fee schedule for the fees applicable for the Authorisation route.

ONLY fee payment by GIRO shall be accepted. The application is subject to a fee payment by the licensed importer.

A GIRO account and a Client Registration and Identification System (CRIS) account with HSA shall have to be set-up prior to payment via GIRO.

To find out more about CRIS account with HSA, please click here.

The application form to set-up a GIRO account with HSA can be downloaded here.

[UPDATED on 12 July 2012] For the importation of unregistered medical devices for exhibition purposes, the importing party shall seek authorisation from HSA prior to importing the specific consignment. Please refer to the circular and application forms below.

[UPDATED on 21 June 2016]
The Special Authorisation Routes guidances and application forms have been updated from Revision 1.1 to Revision 2. With effect from 21 July 2016, only the updated application forms (Revision 2) will be accepted. Any older version of forms will not be processed. 

GN-26: Authorisation Route for import and supply of unregistered medical device on request by qualified practitioner for use on his patient

Purpose

For import and supply of unregistered medical device on request by qualified practitioner for use on his patient

Application Submitter

A licensed importer with Good Distribution Practice for Medical Devices (GDPMDS) certification

Documentary Requirements

Documents include:-

  1. Application Form (Ref number: MDSA-NP)
  2. Annex 2 List of Devices (if applicable)
  3. A copy of Instructions for Use, Product Insert, or Operations Manual by the product owner
  4. A copy of the primary medical device label, and
  5. A copy of the qualified practitioner’s registration under the Medical Registration Act (Cap. 174) or Dentists Act (Cap. 76) with the Medical Council Registration (MCR) Number or Dental Council Registration (DCR) Number clearly legible.
  6. A copy of quality management system certificate (e.g. Good Distribution Practice for Medical Devices (GDPMDS)) if a valid Importer licence with GDPMDS is unavailable.
Validity period of Authorisation

12 months from date of approval

Download.IconPdf     GN-26-R2.1 Guidance on authorisation route for import and supply on request by qualified practitioner
File Size: (462 Kb)

Download.IconDoc      GN-26-R2.1 For patient of Qualified Practitioner Application Form
File Size: (637 Kb)

Download.IconDoc     Annex 1-R2 Distribution Records
File Size: (33 Kb)

Download.IconDoc     Annex 2-R2 List of Devices
File Size: (51 Kb)

GN-27: Authorisation Route for Import and supply of Unregistered Medical Devices to a Private Hospital, Medical Clinic or Clinical Laboratory licensed under the PHMC Act for the use on their patients

Purpose

Import and supply of Unregistered Medical Devices to a Private Hospital, Medical Clinic or Clinical Laboratory licensed under the PHMC Act for the use on their patients

Application Submitter

A licensed importer with Good Distribution Practice for Medical Devices (GDPMDS) certification

Documentary Requirements

Documents include:-

  1. Application Form (Ref number: MDSA-HL)
  2. Annex 2 List of Devices (if applicable)
  3. A copy of Instructions for Use, Product Insert, or Operations Manual by the product owner,
  4. A copy of the primary medical device label, and
  5. A copy of the Clinical Laboratory’s, Medical Clinic’s or Private Hospital’s licence under the Private Hospital and Medical Clinics (PHMC) Act (Cap. 248), with the PHMC Licence Number clearly legible.
  6. A copy of quality management system certificate (e.g. Good Distribution Practice for Medical Devices (GDPMDS)) if a valid Importer licence with GDPMDS is unavailable.

*Attestation by authorised person (i.e. chief executive/ head of department) from facility is required.

Validity period of Authorisation

12 months from date of approval

Download.IconPdf     GN-27-R2.1 Guidance on authorisation route for import and supply on request by PHMC licenced facility
File Size: (459 Kb)

Download.IconDoc     GN-27-R2.1 For patients of PHMC Licensed Clinical Laboratory, Medical Clinic or Private Hospital Application Form
File Size: (634 Kb)

Download.IconDoc     Annex 1-R2 Distribution Records
File Size: (33 Kb)

Download.IconDoc     Annex 2-R2 List of Devices
File Size: (51 Kb)

GN-28: Authorisation Route for Export of Unregistered Medical Devices

Purpose

Import of Unregistered Medical Devices solely for Re-export or for the Export of Unregistered Medical Devices

Application Submitter

ACRA registered company

Documentary Requirements

Documents include:-

  1. Application form (Ref no. MDSA-IR)
  2. Annex 2 List of Device  (if applicable)
Validity period of Authorisation

12 months from date of approval

Download.IconPdf     GN-28-R2.1 Guidance on Authorisation Route for Import for Re-Export
File Size: (338 Kb)

Download.IconDoc     GN-28-R2.1 Import for Re-Export Application Form
File Size: (641 Kb)

Download.IconDoc     Annex 1-R2 Distribution Records
File Size: (33 Kb)

Download.IconDoc     Annex 2-R2 List of Devices
File Size: (51 Kb)

GN-29: Authorisation Route for import and supply unregistered medical devices for non-clinical purpose

Purpose

For import and supply unregistered medical devices for non-clinical purpose

Examples:

  • training equipment (i.e. Not for use on humans);
  • use on animals; or
  • use of in-vitro diagnostic medical devices for research-use only.
  • Application Submitter

    ACRA registered company

    Documentary Requirements

    Documents include:-

    1. Application Form (Ref number: MDSA-NC)
    2. Annex 2 List of Devices (if applicable)
    3. A copy of Instructions for Use, Product Insert, or Operations Manual by the product owner
    4. A copy of the medical device label, including a statement to the effect ‘for supply for non-clinical purpose only’.
    Validity period of Authorisation

    12 months from date of approval

    Download.IconPdf     GN-29-R2.1 Guidance on Authorisation Route for Import and Supply for Non-Clinical Purpose
    File Size: (349 Kb)

    Download.IconDoc     GN-29-R2.1 Import to Supply for Non-Clinical Purpose Application Form
    File Size: (623 Kb)

    Download.IconDoc     Annex 1-R2 Distribution Records
    File Size: (33 Kb)

    Download.IconDoc    Annex 2-R2 List of Devices
    File Size: (51 Kb)

    GN-30 (CR): Authorisation Route for Import on Consignment Basis (Consignment Registered Route)

    Purpose

    For import of registered medical devices by dealers not authorised by the Registrant

    Application Submitter

    Valid importer and wholesaler licence with Good Distribution Practice for Medical Devices (GDPMDS)

    Documentary Requirements

    Documents include:-

    1. Application form (Ref number: MDSA-CR)
    2. Annex 2 List of Devices (if applicable)
    3. Singapore Medical Device Register (SMDR) listing number of the original registered medical device
    4. A copy of Instructions for Use, Product Insert, or Operations Manual by the product owner
    5. A copy of the primary medical device label,
    6. Documentary evidence to show that the medical device is registered in the exporting country (e.g. Free Sale Certificate),
    7. Certified true copy of ISO 13485:2003 certificate for each of the manufacturing sites of the medical device,
    8. Copy of invoice from exporting company indicating the lot number/serial number of each of the medical device to be imported,
    9. Attestation from product owner that the medical device is identical to registered medical device in Singapore, including the manufacturing site, packaging and labelling (refer to Annex 4), and
    10. Undertaking by importer to take responsibility for quality, safety and performance of the medical device to be imported.
    Validity period of Authorisation

     

  • A period of 12 months from the date of approval
  • The quantity approved for import under this authorisation shall only be imported on a single import consignment.
  • Download.IconPdf     GN-30-R2 Guidance on Authorisation Route for Import on Consignment Basis
    File Size: (379 Kb)

    Download.IconDoc     GN-30CR-R2 Import Medical Devices on Consignment Basis (Registered) Application Form
    File Size: (622 Kb)

    Download.IconDoc     Annex 1-R2 Distribution Records
    File Size: (33 Kb)

    Download.IconDoc     Annex 2-R2 List of Devices
    File Size: (51 Kb)

    Download.IconDoc     Annex 4-R2 Product Owner Authorisation Template
    File Size: (24 Kb)

    GN-30(CUR): Authorisation Route for Import on Consignment Basis (Consignment UnRegistered Route)

    Purpose

    For import of a single consignment of low-utilisation unregistered medical devices under an entity's importer's licence.

    * Does not include authorisation to supply, which has to be sought via GN-26 , GN-27 , GN-28 or GN-29.

    Application Submitter

    A valid importer’s licence with Good Distribution Practice for Medical Devices (GDPMDS) certification

    Documentary Requirements

    Refer to GN-30: Guidance on the Requirements for Approval to Import on Consignment Basis.

    Documents include:-

    1. Application form (Ref number: MDSA-CUR)
    2. Annex 2 List of Devices (if applicable)
    3. A copy of Instructions for Use, Product Insert, or Operations Manual by the product owner
    4. A copy of the primary medical device label,
    5. A copy of invoice from exporting company indicating the lot number/serial number of the medical device to be imported.
    Validity period of Authorisation

     

  • A period of 12 months from the date of approval and
  • The quantity approved for import under this authorisation shall only be imported on a single import consignment.
  •  

    Download.IconPdf     GN-30-R2 Guidance on Authorisation Route for Import on Consignment Basis
    File Size: (379 Kb)

    Download.IconDoc     GN-30CUR-R2 Import Medical Devices on Consignment Basis (Unregistered) Application Form
    File Size: (619 Kb)

    Download.IconDoc     Annex 2-R2 List of Devices
    File Size: (51 Kb)

    Download.IconDoc     Annex 3-R2 Distribution Records (for GN-30CUR)
    File Size: (35 Kb)

    Custom-Made Medical Devices

    Custom-made medical devices are exempted from product registration requirement but they must fulfil all of the criteria below, i.e. the medical device:-

    (a) is made at the request of a qualified practitioner and in accordance with the specifications of the qualified practitioner regarding the design characteristics or construction of the medical device;

    (b) is intended to be used only in relation to a particular individual; AND

    (c) is not adapted from a mass-produced medical device.  

    REQUIREMENTS: Please be reminded that the requisite dealer's licences will still apply for the manufacture, import & wholesale activities conducted for custom-made medical devices. Importers of custom-made medical devices are required to keep records of the requesting qualified practitioner’s prescription or equivalent as evidence that the medical device was indeed manufactured based on a qualified practitioner’s request and specifications that is specifically for his patient. This shall be submitted for verification upon request from HSA.

    Importers [both first time importers & those importing custom-made medical devices currently (as of August 2014)] are required to email a list of all custom-made medical devices they are currently importing to the Medical Device Branch via hsa_md_sa@hsa.gov.sg with the email subject, “ List of custom-made MDs”. This list shall be submitted in an excel format using the template below by 31 August 2014.

    Download.IconXls      List of Custom-made Medical Devices_August 2014
    File Size: (13 Kb)

    If the companies wish to import any new custom-made medical devices after 31 August 2014, they can email to hsa_md_sa@hsa.gov.sg the new medical device information, with the email subject, “Update to list of custom-made MDs” in the same excel format, as and when there is an update for their imports. HSA may follow-up with the company on the submitted list, for any verification and clarification.

    Import of an Unregistered Refurbished Medical Device for Return Supply to a PHMC Licensed Facility

    Download.IconDoc     Form for the Export of an Unregistered Medical Device which will be Returned After its Refurbishment.doc
    File Size: (638 Kb)