Your Strategic Partner For Regulatory Compliance
+91 9306468090
|
mdrconsultants.in@gmail.com
Your Strategic Partner For Regulatory Compliance
+91 9306468090
mdrconsultants.in@gmail.com
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Global Regulatory Approvals
ISO Certification (NABCB)
ISO 9001
ISO 14001
ISO 45001
ISO 13485
ISO 27001
CDSCO
Import
Class A Import Registration as per GSR 777(E)
Import License for Predicate Medical Devices (Forms MD-14, MD-15)
Import License for IVD Devices for Testing & Evaluation (Forms MD-16, MD-17)
Import Authorization for Investigational Devices in Government Hospitals (Forms MD-18, MD-19)
Personal Use Medical Device Import License (Forms MD-20, MD-21)
Import Permission for IVD Clinical Performance Evaluations (Forms MD-24, MD-25)
Import Authorization for Novel Medical Devices IVDs (Forms MD-26, MD-27)
Manufacturing
Manufacturing Registration for Class A Medical Devices as per GSR 777(E)
Manufacturing Licenses for Class A & B Medical Devices (Forms MD-3, MD-5)
Loan Licenses for Manufacturing Class A & B Medical Devices (Forms MD-4, MD-6)
Manufacturing Licenses for Class C & D Medical Devices (Forms MD-7, MD-9)
Loan Licenses for Manufacturing Class C & D Medical Devices (Forms MD-8, MD-10)
CDSCO Certificates
MD-42 Certificate
Non-Conviction Certificate
Market Standing Certificate
Neutral Code Certificate
Free Sale Certificate
USFDA
Authorized Agent in India
MDSAP
Medical Device Product Testing
Clinical Evaluation Report
ONDLS
NSWS
EU MDR
BIS
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Approved Medical Devices
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Medical Devices
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