2026 submission window
HSA announced that the submission window for the Registration Support Initiative has been implemented to 31 December 2026. This applies exclusively to the inaugural year of the Initiative and provides stakeholders with additional time to prepare the necessary submissions and obtain relevant endorsements.
Registration Support Initiative
The Initiative was introduced to encourage the registration of unregistered medical devices that are currently accessed through SAR. It supports the transition of eligible devices towards formal product registration in Singapore.
Under the Initiative, potentially eligible devices may be proposed by medical or dental practitioners based on the applicable eligibility criteria. Relevant parties are required to prepare the necessary information and obtain the required endorsements before submission to HSA.
Submission cycle from 2027
From 2027 onwards, submissions under the Initiative will follow the standard annual cycle, with the submission window running from 1 October to 31 December each year.
HSA encourages stakeholders to submit applications early and to review the applicable eligibility criteria and submission requirements before proceeding.
Implications and Significance
The implementation during the inaugural year to identify potentially eligible unregistered medical devices, coordinate with relevant parties and obtain the necessary endorsements. Companies supplying devices through SAR should assess whether their devices may qualify under the Initiative and plan submissions according to the revised 2026 deadline. HSA will waive evaluation fees for eligible devices to reduce the regulatory cost of registration. Unregistered medical devices that meet all the qualification criteria will be eligible for the SAR Registration Support Initiative. HSA will review all submissions and notify companies of their fee waiver eligibility by April of the following year. Companies found eligible will be required to submit their product registration application within one year of receiving notification to qualify for the fee waiver.
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