AMS Endorsement For Unregistered Medical Devices under HSA SAR Initiative

In support of the Health Sciences Authority (HSA), the Academy of Medicine, Singapore (AMS) will manage the application process for endorsing unregistered medical devices under the Special Access Route (SAR) Registration Support Initiative.

AMS will deliver clinical expertise to assess the ongoing necessity of legacy and established medical devices. This ensures that professional medical judgment remains the foundational guide for all device selection.

HSA retains final approval through its independent review process. An AMS endorsement serves only as clinical justification and does not guarantee HSA approval.

If you have any queries, please email: ams.opa(@)ams.edu.sg

SCOPE OF SERVICE
BEFORE YOU APPLY
APPLICABLE FEES

Scope of Review and Services Provided by AMS

AMS will assist with the assessment and evaluation of the clinical judgment put forth by the following applicants first:

Item

Criteria

Reference

(1)

Applicants who had previously applied through Special Access Route (SAR);

(2)

Devices under HSA Criteria A: Essential Life-Saving Medical Devices for Rare Clinical Situations

Medical devices that are higher risk (i.e. Class C or Class D); and
Medical devices that are essential or life-saving in nature and are used in rare clinical situations (i.e. limited use circumstances); and
Medical devices that are not novel, are not based on new technology and have an established history of use for at least 5 years; and
Medical devices supplied at low prices or in small quantities, where the company declares that the cost of registration is not justified by the commercial value of the device in the Singapore market.

(3)

Devices under HSA Criteria B: Legacy MDs with no registered alternatives

Medical devices with at least three years of local clinical use in Singapore through SAR (with at least 2 consecutive GN-26 or GN-27 applications); and
Medical devices with an established history of use for more than 10 years; and
Medical devices that are legacy devices with no registered alternatives available in Singapore

AMS Roles and Limitations

Item				Criteria
(1)				AMS’ endorsement does not determine the outcome of an application under the Registration Support Initiative.
(2)				All submissions remain subject to HSA’s independent review and assessment.
(3)				The endorsement serves to indicate AMS’ support for the clinical justification provided by the Healthcare Practitioner (HCP) and its agreement with the HCP’s assessment of the clinical need for the identified medical device.
(4)				For Devices under HSA Criteria A: Legacy MDs with no registered alternatives AMS will provide professional assessment of essential and life-saving criteria, ensuring devices proposed for consideration demonstrate genuine clinical necessity rather than convenience or preference; and Validation of low-volume usage to confirm that proposed devices serve specialised patient populations with limited alternative treatment options Ensure that device selection is guided by professional medical judgement rather than purely administrative or economic considerations
(5)				Devices under HSA Criteria B: Legacy MDs with no registered alternatives AMS will provide clinical expertise for evaluating legacy device necessity, ensuring there are no existing alternatives and assessing whether established devices continue to serve essential clinical functions; and Ensure that device selection is guided by professional medical judgement rather than purely administrative or economic considerations

Download the following documents below and ensure that you have read through and understand all the terms and conditions thoroughly and carefully.

Item

Document / Forms

File

(1)

HSA's Clinical Justification & Endorsement (CJE) Form
Please ensure that you have downloaded this from HSA's SAR website.

(2)

AMS Request for Endorsement (RE) Form
Do note that the document is in fillable pdf format. Please download and save to your files.

Item				Steps to Apply
(1)				Applicant should download and complete the AMS Request for Endorsement Form & HSA's CJE Form
(2)				*Applicant would need to submit payment of the SGD $300 (+ prevailing GST)* Application Fee and attach the proof of payment together with the application.** Please refer to the Applicable Fees tab for more details. To be paid via PAYNOW* at point of application to:* *UEN No: 197702012E* (Academy of Medicine, Singapore) Reference Number: “Specify name of Qualified Practitioner”
(3)				Send an email to ams.opa(@)ams.edu.sg with subject header: "Seeking AMS Endorsement for Unregistered Medical Device under HSA SAR Support Initiative" together with the three items below AMS Request for Endorsement(RE) Form HSA Clinical Judgement and Endorsement (CJE) Form Proof of payment of Application Fee - Screenshot of transaction via PayNow

Application & Evaluation Fees

Application Fee [Non-Refundable]

Amount	Please attach proof of payment together with application upon submission.
$300 + prevailing GST	To be paid via PAYNOW at point of application to: UEN No: 197702012E (Academy of Medicine, Singapore) Reference Number: “Specify name of Qualified Practitioner”

Evaluation Fee [Will be determined by AMS depending on complexity]

Category of Devices (for unregistered medical devices previously accessed through the SAR)	Simple	Complex	Very Complex	Turnaround Time (TAT)
Category A - Essential/life-saving devices Essential/life-saving devices with low-volume usage where manufacturers cite economic constraints that do not justify the applicable evaluation fees required for HSA registration	$6,000	$10,500	$15,000	90 Days
Urgent Request Charges for Cat A Medical Devices (50% surcharge)	$9,000	$15,750	$22,500	45 Days
Category B - Legacy Devices Legacy devices with established clinical history facing disproportionate administrative burden relative to Singapore's market size	$2,000	$3,500	$5,000	90 Days
Urgent Request Charges for Cat B Medical Devices (50% surcharge)	$3,000	$5,250	$7,500	45 Days