SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
As a whole, the procedure to vary a therapeutic prod- uct registration is largely similar to the registration procedure. • At the pre-submission stage, applicants may submit a pre-submission enquiry to the HSA for any clarification, and may also request a pre-sub- mission meeting with the HSA where necessary to address specific submission issues. • Only MAV applications will be screened, to ensure the correctness of the application type and the completeness of the technical dossier. • During the evaluation stage, applicants who have incorrectly selected an application type or evalua- tion route will be requested to make the appropri- ate changes. In such cases, the applicant will be required to withdraw and resubmit the application if they intend to pursue the application. Transfer procedure A registrant for a registered therapeutic product may be changed from one company to another. Before the submission of a transfer application, the existing registrant should conclude all pending vari- ation applications and pay the annual retention fee. To make a transfer application, the existing registrant first initiates the application via the HSA’s portal. The new registrant will receive an email notice with a PRISM transaction number. The new registrant is then required to retrieve the draft application on the same website, using the transaction number, and submit the completed application in PRISM within 30 calendar days of receiving the email notice. Medical Devices Registration procedure The registration requirements and evaluation route for medical devices depend on their risk classification, whether they have received reference agency approv- als, and their prior safe marketing history. Generally, medical devices that have not received prior reference agency approvals will have to undergo the full evalu- ation route. Please see 4.1 Fast-Track Registration Routes for more details. Medical device registration applications are submit- ted online via the HSA’s portal, SHARE. Applications
under the full or abridged evaluation routes will first be verified for eligibility and completeness before they are accepted for evaluation. If the application does not qualify for the selected evaluation route, it will be re- routed accordingly. A regulatory decision is made after the HSA’s evaluation of the application. Only applica- tions that satisfy the registration requirements will be registered and listed on the Singapore Medical Device Register (SMDR). For applications under the immedi- ate evaluation route, the medical device is registered immediately and listed on the SMDR within an hour. Variation procedure Registrants may be required to submit a “Change Notification” application to the HSA upon changes to the medical device registrations. A Change Notifica- tion to the HSA can be categorised into Notification, Administrative, Technical and Review changes. Some changes may not qualify for a Change Notifica- tion and will require the submission of a new registra- tion. These include: • a change to the intended purpose of the registered medical device; • a change to the risk classification of a registered medical device; • a change to the medicinal substance in a device that incorporates a medicinal product in an ancil- lary role; • any addition of a model or models that do not fulfil the grouping criteria, including permissible vari- ants, as per the GN-12 guidance documents on Grouping of Medical Devices for Product Registra- tion; and • any addition of medical devices with device propri- etary names that are different from the registered devices into a device listing, unless permitted to be listed together under one SMDR listing based on the GN-12 guidance documents on Grouping of Medical Devices for Product Registration. A Change Notification application is submitted to the HSA via SHARE. The following changes must be evaluated by the HSA first, prior to implementation:
• all Technical changes; • all Review changes; and
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