Request for Consideration: Streamlining Medical Device Registration process/ Regulatory Challenges

AMCHAM’s Medical Device Committee made a representation on streamlining medical device registration process/regulatory challenges to Major General Mohammad Yousuf, Director General, Directorate General of Drug Administration, Ministry of Health & Welfare, Bangladesh on August 1st, 2022. The recommendation highlighted DGDA capacity challenges, handling of administrative changes like manufacturer name change and M.R P. (Maximum Retail Price) to help industry stakeholders to obtain faster approvals thereby enabling Bangladesh patients’ access to affordable, new, innovative and novel medical technology devices.