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|'''Department/ Agency'''

|'''Department/ Agency'''

|Machine Learning Enabled Medical Device (MLMD)  Sandbox Development

|Machine Learning Enabled Medical Device (MLMD)  Sandbox Development

|Health Canada is developing a sandbox to test new  regulatory approach for MLMDs. Currently, MLMD can be marketed in Canada if  the device algorithm behaviour is locked to remain the same overtime as what  was presented in the product’s market authorization application. Any change  to the algorithm behaviour requires the submission of an amendment to the  licence. Health Canada wants to test a new regulatory approach that would use  a different method of risk management than requiring a licence amendment so that  the device can change its behaviour over time as it learns from new data it  acquires over time. The current project scope is limited to accessing the  legislative authorities to establish the sandbox and developing the sandbox  application scheme.

|Health Canada is developing a sandbox to test new  regulatory approach for MLMDs. Currently, MLMD can be marketed in Canada if  the device algorithm behaviour is locked to remain the same overtime as what  was presented in the product’s market authorization application. Any change  to the algorithm behaviour requires the submission of an amendment to the  licence. Health Canada wants to test a new regulatory approach that would use  a different method of risk management than requiring a licence amendment so that  the device can change its behaviour over time as it learns from new data it  acquires over time. The current project scope is limited to accessing the  legislative authorities to establish the sandbox and developing the sandbox  application scheme.

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