Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization?

Question

Is it allowed to combine and add more than a medical device or products in one medical device marketing authorization?


Answer

Yes, based on bundling/grouping criteria on guidance MDS-G7: https://sfda.gov.sa/sites/default/files/2021-01/%28MDS-G7%29ar_1.pdf


Medical Devices