CDSCO Registration Complexity
Medical device and pharmaceutical registration under CDSCO involves complex technical dossiers, clinical data requirements, and multi-stage review processes.
Regulatory Compliance
Medical Device and Pharmaceutical
CDSCO regulatory compliance for medical devices and pharmaceutical products covering registration, licensing, and ongoing post-market obligations.
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What is Medical Device and Pharmaceutical?
Medical devices and pharmaceutical products are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act and Medical Devices Rules. Core Compliance provides regulatory affairs support for medical device and pharmaceutical companies — covering CDSCO product registration, import/manufacturing licensing, clinical protocol compliance, and post-market surveillance obligations required under Indian regulations.
Challenges
Key Challenges We Address
Organizations in this space commonly face these compliance hurdles — we are built to solve them.
Import & Manufacturing Licensing
Import licenses for drugs and medical devices have specific Form-specific requirements and annual renewal obligations that require careful management.
Labeling & Packaging Compliance
CDSCO mandates specific labeling requirements for medical devices and drugs — non-compliance can result in import rejection and market withdrawal.
Approach
How We Work
A structured, four-step process designed to deliver compliance outcomes with clarity and accountability.
Regulatory Classification & Applicability
Determining the correct medical device class or pharmaceutical category and identifying all applicable CDSCO licensing, registration, and compliance requirements.
Dossier & Application Preparation
Preparing complete regulatory dossiers, technical files, and CDSCO applications aligned to current guidelines and submission requirements.
CDSCO Coordination & Follow-Up
Active liaison with CDSCO, managing queries and additional information requests during the review and approval process.
Post-Approval Compliance
Managing license renewals, adverse event reporting, labeling compliance, and ongoing post-market surveillance obligations.
Benefits
What You Get
CDSCO registration and import/manufacturing license
Expert dossier preparation reducing rejection probability
Ongoing post-market compliance management
Medical device and drug labeling compliance
Annual renewal and surveillance management
Regulatory guidance on evolving CDSCO requirements
Who This Is For
This service is designed for:
Medical Device ManufacturersPharmaceutical ImportersHealthcare Product BrandsIVD & Diagnostic CompaniesMedical Technology Companies
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Ready to get started with Medical Device and Pharmaceutical?
Our compliance team will assess your specific obligations and deliver a clear action plan tailored to your business.