|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. |