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 () (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 turn-around 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.

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:

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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 / Product Code / Maximum Quantity (UOM)
Name and Address of Importing Company:
MD Importer Licence Number: / ES
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
Duration Indicate how long the quantity will last if applicable)
Has an application for Product Registration been submitted to Medical Device Branch (MDB)? / Yes No
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)? / Yes No
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 the HSA Medical Device Branch (MDB)? / Yes No
If Yes, please fill in the following:
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:
Licence Number: ES / Name of applicant
(Importing Company):
NRIC/Passport Number:
Designation:
Email:
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.
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.
Date / Signature/company stamp of applicant / Tel: / Fax:

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.

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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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