We facilitates the process of obtaining regulatory licenses,
approvals and permissions for medical devices and
diagnostics
Test License from CDSCO/DCGI
Wholesale License (Form MD42) from CDSCO/DCGI
Manufacturing License from CDSCO/DCGI
Loan License from CDSCO/DCGI
Import License from CDSCO/DCGI
Authorized Representative (AR) Services
CE Certificate for European Union
US FDA (510k, PMA, IDE, Q-Sub & Pre-sub meetings)
International CLIA
KPME Registration
EPR Registration from CPCB (NOC from MoEFCC)
PC-PNDT Registration
AERB License (e-Licensing of Radiation
Applications)
Legal Metrology License
NPPA/DPCO Communication and Resolution
Biodiversity Act Compliance Registration
Government e-Marketplace (GeM) Registration
IVD – Performance Evaluation Testing in NIB
COFEPRIS (Mexico) Registration
Health Canada Registration
UKCA (UK) Registration
Singapore & Malaysia Registration
Indonesia & Sri Lanka Registration
WPC – Equipment Type Approval (ETA)
Telecommunication and Engineering Center
(TEC) Approval
Refurbished Medical Device Statutory Guidance
STP/Non-STP Unit registration with STPI
(Software Technology Parks of India) for IT/ITES
companies
EOU (Export Oriented Units) Registration
Established in 2018 (Previously Elite QARA Consulting), D2R is a turnkey medical device advisory services and solutions firm with access to global markets. Our team of 30 cross-functional domain experts specializes in Devices, Diagnostics, and Digital Health, enabling the business success of medical device manufacturers.
+1 (512) 761-0662
+91 63602 99044
info@d2rgc.com
No. 213, GF, Mallappa Layout, Babusapalya, Kalyan Nagar, Bengaluru, Karnataka, India - 560 043.