Pandemic Special Access Route (PSAR) for Supply of Emergency Medical Devices

This interim authorization enables regulatory agility in responding to an emergency that may pose serious threat to the public, such as in the situation of a pandemic.

1.     Introduction

The Pandemic Special Access Route (PSAR) is an interim authorization to supply an "emergency medical device" under regulation 13C of the Health Products (Medical Devices) Regulations.

During an emergency that may pose serious threats to the public, such as in the situation of a pandemic, PSAR provides the Government of Singapore to direct and facilitate the early access of such emergency medical devices during the pandemic, taking into consideration the following:

a) there is reasonable evidence suggesting that the potential benefits outweigh the risks for their use in treating or preventing a disease in an emergency that may pose serious threats to the public; and

b) there is on-going quality, safety and efficacy data generated to support the eventual transition of the interim authorisation to product registration

 

2.     Emergency medical device

A medical device may be designated by the Health Minister as an "emergency medical device" where:

a) The medical device is needed -
       i.     to treat or diagnose any medical condition resulting from a civil defence emergency
       ii.    to prevent the spread or possible outbreak of an infectious disease
       iii.   to treat or diagnose an infectious disease or any medical condition associated with an infectious disease, where the medical condition or infectious disease is potentially serious or life-threatening

b) in the opinion of the Health Sciences Authority, there is -
       i.     preliminary scientific evidence that the medical device has the potential -
                    - to treat or diagnose the medical condition resulting from the civil defence emergency
                    - to prevent the spread or possible outbreak of the infectious disease
                    - to treat or diagnose the infectious disease or any medical condition associated with the infectious disease,

       and

        ii.    ongoing scientific evidence that the potential benefits of the medical device outweigh the known risks of the medical device, to a person on whom the medical device is used

 

3.     Application for an Emergency Medical Device

(a) Prerequisite criteria

Before making an application under the interim authorisation, the applicant must ensure that it fulfils the prerequisite criteria below:

       (i) applicant is a supplier directed by the Government of Singapore to supply for or on behalf of the Government, thereafter, referred to as the company; and

       (ii) The medical device has been assessed by the Government of Singapore to have fulfilled one of more of the conditions specified in paragraph 2(a).

(b) How to submit an application

       (1) For application submission, please click here.

       - Upon successful submission of PSAR Application Form, you will receive the PSAR Application reference number sent to your email.

       (2) Email the following documents to hsa_md_sa@hsa.gov.sg with the Subject quoting the 'PSAR Application reference number'.
     - Device Description
     - Proposed Device Labels and Instructions for Use (IFU)
     - Reference agency's approval(s) - (e.g. US FDA, Australia TGA, Health Canada, EU, Japan MHLW)
     - SG or EC Declaration of Conformity
     - Design verification and validation data
          = Sterilisation validation (if supplied sterile)
          = Evidence demonstrating conformity to relevant product specific standards
     - Proof of QMS - E.g. ISO13485 certificate, conformity to US FDA Quality System Regulations or Japan MHLW Ordinance 169
     - Clinical evidence

Please note that further input request will be issued to the applicant if clarification or additional information is required.