CDSCO Approvals & New Product Development
We provide the consultancy in regulatory affairs in the areas of Medical Devices and In-vitro Diagnostic Kits pertaining to the following segments:
Site and Product Registration
New Product Approval
Import registration of Medical Devices and In-vitro Diagnostic Kits
Free Sale Certificate / GMP Certificate / Market Standing Certificates etc..
Export Permissions
Establishing Quality management System (ISO 13485:2016) as per MDR 2017
Bio-compatibility / Bio-equivalence/ Bio-Availability Studies
Joint Ventures
Technology Transfers
Dossier development & Technical Files as per MDR 2017(Plant Master File & Device Master Files)
