MEDICAL DEVICE BRANCH
HEALTH PRODUCTS REGULATIONS GROUP
Form No.: MDSA-CUR1
Date of Revision: June 2010
SUBJECT: GUIDE TO APPLICATION FOR APPROVAL TO IMPORT MEDICAL
DEVICES ON CONSIGNMENT BASIS (CONSIGNMENT UNREGISTERED ROUTE)
1.
Please refer to GN-30: Guidance on Approval to Import Medical Devices on
Consignment Basis for more information on this authorisation route.
2.
The completed application form and requisite documents shall be submitted to
HSA via fax (+65 6478 9028), email (hsa_md_sa@hsa.gov.sg) or mailed to the
Medical Device Branch, Health Products Regulations Group, Health Sciences
Authority, 11 Biopolis Way #11-03 Helios, Singapore 138667, by the licensed
importer (i.e. section A, B and C) of the medical device.
3.
The letter of approval would be sent to the licensed importer based on contact
details indicated in section B.
4.
Additional documentary requirements for this authorisation route are as follows:
 Intended purpose, as stated in Instructions for Use, Product Insert, or
Operations Manual by the product owner (documentary evidence to be
provided),
 A copy of the primary medical device label, and
 A copy of invoice from exporting company indicating the lot number/serial
number of the medical device to be imported.
All incomplete applications and applications with illegible entries shall be rejected.
5.
The licensed importer shall only be permitted to IMPORT the medical device
through this authorization route. In order to supply the medical device, subsequent
authorisation through the following routes shall have to be obtained first:
 GN-26: Supply on Named-Patient Basis
 GN-27: Supply to a Clinical Laboratory, Medical Clinic or Private Hospital
licensed under the PHMC Act
 GN-28: Export of Unregistered Medical Devices
 GN-29: Supply for Non-Clinical Purpose
6.
For this authorisation route, ONLY fee payment by GIRO shall be accepted. The
application is subject to a fee payment by the licensed importer.
GIRO Payment
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 submit an online application at the
following webpage:
http://www.hsa.gov.sg/publish/hsaportal/en/services/cris.html
The application form to set-up a GIRO account with HSA may be downloaded from
the following webpage:
http://www.hsa.gov.sg/publish/hsaportal/en/services.html
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MEDICAL DEVICE BRANCH
HEALTH PRODUCTS REGULATIONS GROUP
Form No.: MDSA-CUR1
Date of Revision: June 2010
SUBJECT: GUIDE TO APPLICATION FOR APPROVAL TO IMPORT MEDICAL
DEVICES ON CONSIGNMENT BASIS (CONSIGNMENT UNREGISTERED ROUTE)
7.
The fee applicable to this authorisation route is specified in the fee schedule.
8.
For enquiries, please contact the Medical Device Branch at: telephone number: +65 6866 3560 or
 fax number: +65 6478 9028.
 email: hsa_md_sa@hsa.gov.sg
Page 2 of 4
Form No.: MDSA-CUR1
Date of Revision: June 2010
REPUBLIC OF SINGAPORE
HEALTH SCIENCES AUTHORITY
THE HEALTH PRODUCTS ACT (No 15 of 2007)
APPLICATION FOR APPROVAL TO IMPORT ON
CONSIGNMENT BASIS – CONSIGNMENT UNREGISTERED
(CUR)
SECTION A - MEDICAL DEVICE AND LICENSED IMPORTER DETAILS
Device Name (including accessories): Identifier (e.g. model number)
Name of Product Owner:
Name and address of Licensed Importer:
Licence Number: ES
Name of applicant authorised by Licensed Importer:
Quantity
Tick if the medical device has
regulatory approval from the following 5
reference agencies:
Australian TGA
Health Canada
EU (CE mark)
Japan MHLW
US FDA
NRIC/Passport Number:
Tel No:
Fax No:
Is this a registered medical device?
Yes
No
SECTION B – DECLARATION BY LICENSED IMPORTER
With reference to the information listed in section A of this form,
I hereby attest that the information provided on this application form and accompanying documents and
attachments for the import on consignment basis of medical devices is accurate, correct and complete.
I am aware of my duties and obligations under Part VIII of the Health Products Act and shall ensure that they
are performed.
I shall undertake responsibility for the quality, safety and performance the medical device to be imported.
I declare that there is currently no Registrant for this medical device in Singapore.
I undertake to indemnify the government against all actions, claims or proceedings in respect of any adverse
event, injury to or death of any person whomsoever arising out of or in connection with the use of the above
unregistered medical device.
I am informed and I understand that it is a serious offence under Section 46(10) of the Health Products Act to
make any statement or furnish any document which I know to be false or do not believe to be true.
I am aware that supply of the above-listed medical devices under this import approval is prohibited and would
be an offence under Section 15 of the Health Products Act.
Date
Name & Signature of applicant / company stamp
NOTE:
Signing and submitting this form constitutes acknowledgement that the information in pages 1 and 2 of
this form have been read and understood and that unless the conditions of approval are adhered to, any
authorisation to import and supply would be invalidated.
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Form No.: MDSA-CUR1
Date of Revision: June 2010
SECTION C - FEE PAYMENT (FOR GIRO TRANSACTION) AND MODE OF CORRESPONDENCE
CRIS Client Code of Licensed Importer:
HSA GIRO Customer Reference Number:
Preferred mode of correspondence (i.e. letter of approval, input request, etc): Fax
Email
NOTE:
Signing and submitting this form constitutes acknowledgement that the information in pages 1 and 2 of
this form have been read and understood and that unless the conditions of approval are adhered to, any
authorisation to import and supply would be invalidated.
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