MEDICAL DEVICE BRANCH
HEALTH PRODUCTS REGULATIONS GROUP
Form No.: MDSA-NP1
Date of Revision: April 2011
SUBJECT: GUIDE TO APPLICATION FOR EXEMPTION FROM PRODUCT
REGISTRATION FOR THE IMPORT OF AN UNREGISTERED MEDICAL DEVICE FOR
SUPPLY ON NAMED-PATIENT BASIS
1.
Please 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 for more information on this authorisation route.
2.
The completed application form and requisite documents shall be submitted to
HSA via email (hsa_md_sa@hsa.gov.sg) (i.e. section A, B, C and D) of the medical
device by the qualified practitioner. This is to ensure any information related to
the patient is kept confidential. Other modes of submission may affect the turnaround time of the application,.
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 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, and
 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.
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 (for category A or non-category A patients), must be filled by the
requesting qualified practitioner and submitted by the qualified practitioner. The
qualified practitioner is also to certify in Section D that he/she will take full
responsibility for the safety and performance of this medical device related to its
use on the named-patient, as the medical device has not been registered with the
Health Sciences Authority.
7.
Category A patients are defined as “persons who are seriously ill with a condition
from which death is reasonably likely to occur within a matter of months, or from
which premature death is reasonably likely to occur in the absence of early
treatment.
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MEDICAL DEVICE BRANCH
HEALTH PRODUCTS REGULATIONS GROUP
Form No.: MDSA-NP1
Date of Revision: April 2011
SUBJECT: GUIDE TO APPLICATION FOR EXEMPTION FROM PRODUCT
REGISTRATION FOR THE IMPORT OF AN UNREGISTERED MEDICAL DEVICE FOR
SUPPLY ON NAMED-PATIENT BASIS
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
8.
The fee applicable to this authorisation route is specified in the fee schedule.
9.
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 6
Form No.: MDSA-NP1
Date of Revision: April 2011
REPUBLIC OF SINGAPORE
HEALTH SCIENCES AUTHORITY
HEALTH PRODUCTS ACT (No 15 of 2007)
APPLICATION FOR EXEMPTION FROM PRODUCT
REGISTRATION FOR THE IMPORT OF AN
UNREGISTERED MEDICAL DEVICE FOR SUPPLY ON
NAMED-PATIENT BASIS
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 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 quantity will last if applicable)
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-NP1
Date of Revision: April 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:
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 the HSA 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
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-NP1
Date of Revision: April 2011
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.
NRIC/Passport Number:
Designation:
Email:
I undertake to maintain proper records on the import and
supply of the medical device and to adhere to the conditions
of approval.
I undertake to ensure that upon completion of the treatment,
all remaining supplies of the medical device would be
shipped back 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 5 of 6
Form No.: MDSA-NP1
Date of Revision: April 2011
SECTION D - FOR NAMED-PATIENT BASIS
(To be completed by Qualified Practitioner)
With reference to the information listed in section A of this form,
Patient’s particulars
Category A patient:
Yes
No
Name:
IC no./Passport no.:
Nationality:
Address:
Sex:
Male
Female
Age:
years
Diagnosis
Clinical justification for
not using medical
devices registered on the
SMDR
Qualified Practitioner’s
particulars
(all fields are to be
completed)
Full name:
MCR or DCR Number:
Designation:
Department:
Name of Hospital/Clinic:
Address:
Tel no:
Fax no:
Email:
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, <name of qualified
practitioner>, undertake full responsibility for the use of this medical device on the named patient listed above
and shall adhere to the conditions of approval.
2. I will also maintain records on the particulars of my patient 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.
Date
Signature and Stamp of Qualified Practitioner
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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