The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals, medical devices, and diagnostics. To introduce healthcare products in the Indian market, companies must comply with CDSCO regulations and obtain the required approvals and licenses.
At Regulant, we specialize in providing complete regulatory solutions that simplify this process. Our team ensures your products meet CDSCO requirements while avoiding unnecessary delays and compliance risks.
Let's Simplify it
Step 1 – We Screen
Initial evaluation of client requirements.
Identify Class
Checking availability and validity of essential documents.
Identifying gaps to avoid rejections and delays.
Step 2 – We Collect
Regulant receives documents from the client.
Detailed review of manufacturer’s technical files, certifications, and supporting records.
Secure handling of client data and documentation
Step 3 – We Prepare
Formatting and compiling docs as per CDSCO guidelines.
Preparation of dossiers, Plant Master File (PMF), and Device Master File (DMF).
Ensuring compliance with MDR, 2017 requirements.
Step 4 – We Obtain
Active submission of applications on the CDSCO portal.
Responding to queries raised by regulators.
Guiding clients through the approval journey until the license is successfully granted.
Our CDSCO Services
Our CDSCO Services cover:
End-to-end support for Import & Manufacturing Licenses for medical devices.
Registration and approval of medical devices under the Medical Device Rules (MDR), 2017.
Preparation and submission of technical dossiers (Form MD-14, MD-15, etc.).
Assistance in obtaining Test Licenses, Wholesale Licenses, and Form 41 approvals.
Post-approval compliance management, renewals, and regulatory reporting.
Direct liaison with CDSCO authorities to ensure smooth communication and timely approvals.
Have any questions?
If you have any questions about the therapies, feel free to contact us.