MEDICAL DEVICE BRANCH
HEALTH PRODUCTS REGULATIONS GROUP
Form No.: MDSA-HL1
Date of Revision: April 2011
SUBJECT: GUIDE TO APPLICATION FOR EXEMPTION FROM PRODUCT
REGISTRATION FOR THE IMPORT OF UNREGISTERED MEDICAL DEVICES FOR
SUPPLY TO A CLINICAL LABORATORY, MEDICAL CLINIC OR PRIVATE HOSPITAL
LICENSED UNDER THE PHMC ACT
1.
Please refer to GN-27: Guidance on the Requirements for Exemption from Product
Registration for the Import of Unregistered Medical Devices for Supply to a Clinical
Laboratory, Medical Clinic or Private Hospital licensed under the PHMC Act for
information on this authorisation route.
2.
The completed application form and requisite documents shall be submitted to
HSA via email ([email protected]) (i.e. section A, B, C and D) of the medical
device. Other modes of submission may affect the turn-around time of the
application.
3.
On approval, the licence shall be emailed to the licensed importer based on contact
details indicated in section B.
4.
Additional documentary requirements for this permit application:
 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,
 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.
All incomplete applications and applications with illegible entries shall be rejected.
5.
Sections A, B and C must be completed and duly signed by the licensed importer.
For the purpose of Customs Declaration, the HS Code of the device must be
indicated in the space provided in Section A – Medical Device Details or
Annex hereto.
The information must be typed or neatly written in the application form. The
application will be deemed incomplete if any of the sections are not filled and
incomplete applications will be rejected.
6.
Section D must be completed by a person authorised by the Clinical Laboratory,
Medical Clinic or Private Hospital (i.e. head of department or its equivalent). The
said person is also to attest in Section D that he/she will take full responsibility for
the safety and performance of this medical device related to its use in their Clinical
Laboratory, Medical Clinic or Private Hospital, as the medical device has not been
registered with the Health Sciences Authority.
7.
For this authorisation route, ONLY fee payment by GIRO shall be accepted. The
application is subject to a fee payment by the licensed importer.
Page 1 of 6
MEDICAL DEVICE BRANCH
HEALTH PRODUCTS REGULATIONS GROUP
Form No.: MDSA-HL1
Date of Revision: April 2011
SUBJECT: GUIDE TO APPLICATION FOR EXEMPTION FROM PRODUCT
REGISTRATION FOR THE IMPORT OF UNREGISTERED MEDICAL DEVICES FOR
SUPPLY TO A CLINICAL LABORATORY, MEDICAL CLINIC OR PRIVATE HOSPITAL
LICENSED UNDER THE PHMC ACT
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.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/cris.html
The fee applicable to this authorisation route is specified in the fee schedule.
For enquiries, please contact the Medical Device Branch at: telephone number: +65 6866 3560 or
 fax number: +65 6478 9028.
 email: [email protected]
Page 2 of 6
Form No.: MDSA-HL1
Date of Revision: Apr 2011
REPUBLIC OF SINGAPORE
HEALTH SCIENCES AUTHORITY
HEALTH PRODUCTS ACT (No 15 of 2007)
APPLICATION FOR EXEMPTION FROM PRODUCT
REGISTRATION FOR THE IMPORT OF UNREGISTERED
MEDICAL DEVICES FOR SUPPLY TO A CLINICAL
LABORATORY, MEDICAL CLINIC OR PRIVATE HOSPITAL
LICENSED UNDER THE PHMC ACT
To be completed by HSA Medical Device Branch:
Approved:
Yes
No
Authorisation Licence No:
SECTION A - MEDICAL DEVICE DETAILS ((To be completed by licensed importer- Please Replicate Section
A or use Annex hereto if there are multiple devices on this application)
Device Name (including accessories):
Identifier (e.g. model number)
HS
Code
Produ
ct
Code
Maximum
Quantity
(UOM)
Name and Address of Importing Company:
MD Importer
Licence Number:
ES
100
80
60
East
West
40
North
20
0
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
Name and address of product owner:
Duration (Indicate how long the applied quantity is for)
Has an application for Product Registration been submitted to Medical Device Branch
(MDB)?
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
Yes
No
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.
Page 3 of 6
Form No.: MDSA-HL1
Date of Revision: Apr 2011
If Yes, please fill in the following:
MEDICS Job Reference No.:
Date of submission:
Name and address of product owner:
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
Has an application for Product Registration been submitted to Medical Device Branch
(MDB)?
If Yes, please fill in the following:
Yes
No
MEDICS Job Reference No.:
Date of submission:
SECTION B - PARTICULARS OF LICENSED IMPORTER (To be completed by licensed importer)
Name and Address of Importing Company:
Name of applicant
(Importing Company):
Licence Number: ES
NRIC/Passport Number:
With reference to the information listed in section A of this form,
I confirm that I am a duly authorised representative of the
Company to make this undertaking on behalf of the Company. The
Company undertakes to maintain proper records on the import and
supply of the medical device.
Designation:
Email:
I undertake to maintain proper records on the import and supply of
the medical device.
I undertake to ensure that upon completion of the treatment, all
remaining supplies of the medical device would be returned to the
product owner.
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.
Tel:
Date
Fax:
Signature/Company stamp of applicant
SECTION C - FEE PAYMENT (FOR GIRO TRANSACTION) AND MODE OF CORRESPONDENCE
(To be completed by licensed importer)
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.
Page 4 of 6
Form No.: MDSA-HL1
Date of Revision: Apr 2011
SECTION D (To be completed by Head of Department (or equivalent) of Clinical Laboratory, Medical Clinic or
Private Hospital)
With reference to the information listed in section A of this form,
Clinical justification for
not using registered
medical devices
Particulars of Head of
Department (or
equivalent) in Clinical
Laboratory, Medical
Clinic or Private Hospital
Full name:
MCR or DCR Number (if applicable):
Designation:
Department:
Tel no:
Fax No:
Email:
Clinical Laboratory,
Medical Clinic or Private
Hospital Details
(all fields are to be
completed)
Name of Hospital/Laboratory:
PHMC Licence Number:
Address:
Tel no:
Fax no:
With reference to the information listed in section A of this form,
1. As the medical device has not been registered with the Health Sciences Authority, I, <head of
department>, undertake full responsibility for the use of this medical device and shall adhere to the conditions
of approval.
2. I will also maintain records on the particulars of my patient(s) treated with the medical device.
3. I will ensure that this medical device will be used or administered in accordance to its intended purpose
and indications for use as stated in the product owner’s instructions for use.
4. 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.
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.
Page 5 of 6
Form No.: MDSA-HL1
Date of Revision: Apr 2011
Date
Signature and Stamp of Head of Department
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.
Page 6 of 6