Regulatory Services
CDSCO and DCGI Approvals
CDSCO and DGCI regulatory submissions approvals
CDSCO Registration & Licensing of Class A, B, C&D Devices
(Manufacturing, Import, Sale, Distribution & Clinical Investigation).
Medical Devices and In-vitro Diagnostic Kits pertaining
We provide consultancy in regulatory affairs in the areas of Medical Devices and In-vitro Diagnostic Kits pertaining to the following segments.
The 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 a Quality Management System (ISO 13485:2016) as per IMDR 2017
Bio-compatibility / Bio-equivalence/ Bio-Availability Studies
Dossier development & Technical Files as per IMDR 2017
(Plant Master File & Device Master Files)