Product licensing with CDSCO India
What's included in
Product Licensing with CDSCO India
The size of the Indian medical devices market is expected to grow to $50 Bn by 2030. Our in-depth expertise will ensure compliance with medical device regulations in India and obtain applicable approvals such as Manufacturing/ Import licenses from the regulatory body CDSCO.
Preparation and Assessment
Conduct a comprehensive assessment of your medical device. Prepare the necessary documentation, including Device Master File, Plant Master File and Submission Dossier aligning with CDSCO requirements.
Application Submission
Submit the product license application to CDSCO. Ensure accuracy and completeness of documentation to facilitate a smooth review process.
Review and Evaluation
CDSCO reviews the application, assessing technical and clinical data. Collaborate with regulatory authorities to address queries and provide additional information as needed.
Revolutionize Your MedTech Venture with MedQ Compliance!
Unlock regulatory mastery, ensure quality compliance, and expedite market entry. Elevate your MedTech success story with our tailored solutions and expert guidance.
Frequently Asked
Get quick answers to common questions about MedQ Compliance’s services and Medtech regulatory consulting.
You can connect with us through our website, LinkedIn, Google search, or referrals to schedule an initial consultation.
MedQ Compliance specializes in preparing a tailored regulatory strategy for your medical device solution, support in building technical documentation and completing regulatory submissions in global markets such as US FDA, EU MDR/ IVDR, CDSCO India, Singapore HSA, and other countries.
MedQ Compliance prioritizes confidentiality, implementing secure processes for information protection.
Timelines for regulatory approvals depend on multiple factors such as completeness of the technical dossier, meeting applicable requirements and timely communication with the regulatory bodies. MedQ Compliance optimizes all these key areas that ensure high efficiency and minimal timelines for regulatory clearances.