Request for Consideration : Ease of doing Business : MedTech Regulatory Operational challenges in retention of import license and subsequent endorsements

Medical Device Committee Regulatory Team met with Mr Aseem Sahu on 28th July at CDSCO and addressed the Operational Challenges in retention of Import Licese and subsequnet endorsements and other major concerns. As advised by Mr Sahu, AMCHAM submitted the recommedations for consideration and shared Issues/Recommendations and Rationals to improve
1. Pdf copy Original/Retained IL and originally submitted documents
2. Lack of Visibility of Model numbers in Retained IL
3. Generation of challan (post payment) at BharatKosh portal is not consistent
4. Removal of model numbers -no option available to remove the model numbers at the time of retention application submission or via post approval change.
5. Post Approval Changes – reflected in MD-14 but not in MD-15 license