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Singapore: "NextGen MD Initiative" for Next Generation Medical Device Registrations (w.e.f 1 July 2024)

NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of next-generation medical devices by leveraging the submitted data to HSA for registered devices.


It is well-known that medical devices frequently undergo multiple iterations for enhancements based on real-world experience and feedback. These improved devices are then rebranded to distinguish them while retaining most of their original characteristics and data. Hence, to support the registration of these next-generation medical devices, which cannot be registered under the Change Notification (CN) pathway, the Health Sciences Authority (HSA) launched this new opt-in initiative, effectively enrolled starting 1 July 2024.


Applicants must submit the documentary submission as per GN-15 and the NextGen MD form via MEDICS. Please ensure all the documents are complete before submission as no further amendments will be entertained. Any incomplete information related to the NextGen MD form; the application will be reviewed per the standard Full Evaluation Route.


Below are the eligibility criteria for the Next-Generation Medical Devices:

  • Applicable to Class B, C, and D medical devices submitted under Full Route (except for MD-drug combination).


While, for the registered devices, must meet the following requirements:

  • Same product owner & registrant as the next-generation device

  • Registered with HSA via Abridged or Full Route

    • If the changes made to the registered device were leveraged, the changes must be registered via Review or Technical Change Notification (CN).

    • Registered on the Singapore Medical Device Register (SMDR) at the point of submission of the next-generation medical device.

 


Contact us at info@arqon.com for more information.


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