Overview of Supply
From 10 August 2010 onwards, with the exception of the following:-
- class A and B medical devices,
- medical devices for clinical trials, and
- custom-made medical devices
all other medical devices shall either have to be:
- registered on SMDR,
- placed on the Transition List, 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 set-up your CRIS account with HSA, please proceed to submit an online application here.
The application form to set-up a GIRO account with HSA may be downloaded here.
|
GN-26: Authorisation Route for Supply on Named-Patient Basis
Purpose | To seek exemption from product registration for the import and supply of an unregistered medical device for supply to named-patient |
Licence | Only licensed importer will be allowed to import the unregistered medical device |
Application Procedure | Refer to GN-26: Application Form for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply on Named-Patient Basis |
Application Submitter | Qualified practitioner (patient confidentiality) |
Documentary Requirements | Refer to GN-26: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply on Named-Patient Basis Documents include:-
|
Validity period of Authorisation | 6 months from date of approval |
|
GN-26: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply on Named-Patient Basis
File Size: (68 Kb)
|
GN-26: Application Form for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply on Named-Patient Basis
File Size: (664 Kb)
|
|
|
GN-27: Authorisation Route for Supply on Request of PHMC-Licensed Facility
Purpose | To seek exemption from product registration for the import and supply of an unregistered medical device to a clinical laboratory, medical clinic or private hospital licensed under the PHMC Act (Cap. 248) |
Licence | Only licensed importer will be allowed to import the unregistered medical device |
Application Procedure | Refer to GN-27: Application Form for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply to Clinical Laboratory, Medical Clinic or Private Hospital licensed under the PHMC Act. |
Application Submitter | Licensed importer |
Documentary Requirements | Refer to GN-27: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply to Clinical Laboratory, Medical Clinic or Private Hospital licensed under the PHMC Act. *Attestation by authorised person (i.e. chief executive/ head of department) from facility is required. Documents include:-
|
Validity period of Authorisation | 6 months from date of approval |
|
|
|
|
|
GN-28: Authorisation Route for Export of Unregistered Medical Devices
Purpose | To seek exemption from product registration for the import of an unregistered medical device solely for re-export |
Licence | Only licensed importer will be allowed to import the unregistered medical device |
Application Procedure | Refer to GN-28: Application Form for Exemption from Product Registration for the Import of an Unregistered Medical Device solely for Re-export |
Application Submitter | Licensed importer |
Documentary Requirements | Refer to GN-28: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device solely for Re-export |
Validity period of Authorisation | 12 months from date of approval |
|
GN-28: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device solely for Re-export
File Size: (65 Kb)
|
GN-28: Application Form for Exemption from Product Registration for the Import of an Unregistered Medical Device solely for Re-export
File Size: (622 Kb)
|
|
|
|
GN-29: Authorisation Route for Supply for Non-Clinical Purpose
Purpose | To seek exemption from product registration for the import of an unregistered medical device to supply for non-clinical purpose. e.g. for display at exhibition, training purposes, supply of unregistered in-vitro diagnostic medical device for research-use only purposes, etc |
Licence | Only licensed importer will be allowed to import the unregistered medical device. |
Application Procedure | Refer to GN-29: Application Form for Exemption from Product Registration for the Import of an Unregistered Medical Device to Supply for Non-Clinical Purpose |
Application Submitter | Licensed importer |
Documentary Requirements | Refer to GN-29: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device to Supply for Non-Clinical Purpose. Documents include:-
|
Validity period of Authorisation | 12 months from date of approval |
|
GN-29: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device to Supply for Non-Clinical Purpose
File Size: (64 Kb)
|
GN-29: Application Form for Exemption from Product Registration for the Import of an Unregistered Medical Device to Supply for Non-Clinical Purpose
File Size: (620 Kb)
|
|
|
GN-30 (CR): Authorisation Route for Import on Consignment Basis (Consignment Registered Route)
Purpose | For dealer not authorised by the Registrant to seek authorisation from HSA for the import of a registered medical device |
Licence | Only licensed importer will be allowed to import the registered medical device. Once approval is obtained, supply can be performed by licensed wholesaler. |
Application Procedure | Refer to GN-30: Application Form for Approval to Import on Consignment Basis (Consignment Registered) |
Application Submitter | Licensed importer |
Documentary Requirements | Refer to GN-30: Guidance on the Requirements for Approval to Import on Consignment Basis. Documents include:-
|
Validity period of Authorisation | 3 months from date of approval |
|
|
GN-30: Application Form for Approval to Import on Consignment Basis (Consignment Registered)
File Size: (607 Kb)
|
|
|
GN-30(CUR): Authorisation Route for Import on Consignment Basis (Consignment UnRegistered Route)
Purpose | To seek authorisation* to import 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. |
Licence | Only licensed importer will be allowed to import the unregistered medical device |
Application Procedure | Refer to GN-30: Application Form for Approval to Import on Consignment Basis (Consignment Unregistered Route) |
Application Submitter | Licensed importer |
Documentary Requirements | Refer to GN-30: Guidance on the Requirements for Approval to Import on Consignment Basis. Documents include:-
|
Validity period of Authorisation | 3 months from date of approval |
|
|
GN-30: Application Form for Approval to Import on Consignment Basis (Consignment Unregistered Route)
File Size: (607 Kb)
|
|
|
Supply of a Custom Made Medical Device
|
Form for the Import of an Unregistered Custom Made Medical Device for Supply on Named-Patient Basis.doc
File Size: (645 Kb)
|
Import of an Unregistered Refurbished Medical Device for Supply to a PHMC Licensed Facility
|
Form for the Export of an Unregistered Medical Device which will be Returned After its Refurbishment.doc
File Size: (638 Kb)
|
