On 25th February 2021, the Medical Devices Branch (MDB) has introduced a new self-help tool to guide in grouping of medical devices for purposes of premarket registration. This medical device grouping tool will help determine the grouping category that is most appropriate for your medical devices when submitting a product registration application. This grouping tool is an addition to the existing compendium of medical device registration and licensing self-help tools which have been developed to assist stakeholders and facilitate the registration process for medical devices.
Key features:
- Interactive Q&A format
- Provides guides and info if unsure
- Final answer card provides info on next steps, future amendments and alternative grouping options for consideration
- Users are able to print the outcome with their device’s name
More details are found on the Singapore HSA website:
https://www.hsa.gov.sg/medical-devices/registration/identifying-md-grouping/