India’s healthcare and medical technology sector is growing rapidly, creating significant opportunities for manufacturers, importers, and distributors. However, before any medical device or regulated healthcare product can be marketed in India, it must comply with the requirements of the Central Drugs Standard Control Organisation (CDSCO). Understanding and completing the cdsco registration process correctly is therefore essential for market entry and regulatory compliance.
This guide explains the CDSCO registration framework, the process involved, and how businesses can navigate it efficiently.
What Is CDSCO?
CDSCO is India’s national regulatory authority for pharmaceuticals, medical devices, diagnostics, and certain healthcare products. It operates under the Ministry of Health and Family Welfare and is responsible for ensuring that medical products sold in India are safe, effective, and of good quality.
Under the Medical Devices Rules, 2017 (as amended), many devices that were previously unregulated are now subject to formal registration and licensing.
Understanding Medical Device Registration in India
Medical device registration is mandatory for manufacturers and importers of notified medical devices before they can be sold or distributed in India. Devices are classified into four risk-based categories:
Class A (Low Risk)
Class B (Low to Moderate Risk)
Class C (Moderate to High Risk)
Class D (High Risk)
The level of regulatory scrutiny and documentation increases with the risk class of the device.
Key Elements of the CDSCO Registration Process
The registration process involves multiple steps:
1. Device Classification
The first step is identifying the correct risk class of the device and whether it falls under the notified list.
2. Appointment of Authorised Indian Agent
Foreign manufacturers must appoint an authorised Indian representative responsible for regulatory compliance.
3. Preparation of Documentation
This includes technical files, device master files, plant master files, quality certifications, and clinical or performance data where required.
4. Online Submission
Applications are filed through the CDSCO online portal along with prescribed fees.
5. Regulatory Review and Approval
CDSCO reviews the submission, may raise queries, and grants approval in the form of a cdsco license once requirements are met.
Medical Device Product Registration Explained
Medical device registration focuses on registering each specific device model or product for sale in India. Even if a manufacturer is licensed, each product must be properly listed and approved before it can be marketed.
This ensures traceability, safety monitoring, and post-market surveillance.
Common Challenges in the Process
Companies often face difficulties such as:
Incorrect device classification
Incomplete technical documentation
Delays in responding to CDSCO queries
Lack of clarity on evolving regulatory changes
Coordination issues between global headquarters and Indian agents
These challenges can delay approvals and affect business timelines.
The Role of Professional Support
Engaging experienced regulatory professionals can significantly simplify the process. They help interpret regulations, prepare compliant documentation, manage timelines, and communicate effectively with regulators.
How ASC Group Supports CDSCO Compliance
ASC Group provides end-to-end regulatory advisory services for companies seeking CDSCO registration and licensing in India.
ASC Group supports clients by:
Assessing product classification and regulatory applicability
Preparing and reviewing technical and compliance documentation
Managing online submissions and regulatory follow-ups
Coordinating with Indian agents and manufacturers
Supporting post-approval compliance and renewals
Their structured approach ensures accuracy, efficiency, and regulatory alignment throughout the process.
Importance of Ongoing Compliance
Approval is not the end of regulatory responsibility. Companies must comply with:
Post-market surveillance and reporting
Adverse event reporting obligations
Periodic renewals and updates
Labelling and packaging standards
Quality system maintenance
Non-compliance can result in suspension or cancellation of registration.
Conclusion
The CDSCO registration process is a vital gateway for accessing the Indian healthcare market. While the regulatory framework is designed to ensure safety and quality, it can be complex for businesses unfamiliar with Indian regulations.
By understanding the requirements, preparing thoroughly, and working with experienced advisors like ASC Group, companies can complete cdsco registration, obtain the required cdsco license, and successfully complete medical device registration and medical device product registration with confidence and clarity.