Medical Device Registration in India (CDSCO)
CDSCO Regulations Guide for Seamless Medical Device Registration in India
Planning to Launch Your Medical Device in India? Navigate CDSCO Regulations with Confidence.
Getting your medical device approved in India requires strict compliance with regulations set by the Central Drugs Standard Control Organization (CDSCO). With evolving rules and complex documentation requirements, expert guidance can make all the difference. Operon Strategist offers end-to-end regulatory consulting to streamline your medical device registration in India—whether you’re a manufacturer, importer, or distributor.
What is CDSCO and Why Is It Important?
CDSCO, under the Ministry of Health and Family Welfare, is the national authority overseeing the safety, quality, and efficacy of medical devices in India. Since the implementation of the Medical Device Rules (MDR) 2017, the registration process has become more stringent, requiring formal approvals, documentation, and sometimes inspections before devices can be marketed in India.
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Medical Device Classification as per CDSCO
Under MDR 2017, medical devices are categorized based on risk:
- Class A – Low risk (e.g., bandages, examination gloves)
- Class B – Low to moderate risk (e.g., blood pressure monitors, thermometers)
- Class C – Moderate to high risk (e.g., catheters, implants)
- Class D – High risk (e.g., heart valves, life-supporting devices)
Each classification determines the level of scrutiny and documentation required for approval.
Step-by-Step Process to Register Your Medical Device in India
- Identify Your Device Classification
Use MDR 2017 to determine the class of your device. This helps define the regulatory pathway and documentation requirements. - Prepare Technical Documentation
This includes device specifications, design details, risk analysis, labeling, manufacturing process, and performance testing data. All documents must comply with CDSCO guidelines. - Appoint an Indian Authorized Agent
Foreign manufacturers must appoint a licensed Indian agent to represent them. This agent handles communication with CDSCO and submits your application on your behalf. - Submit the Application
The application should be submitted in the prescribed format along with all required documentation and proof of fee payment. - Undergo Review & CDSCO Evaluation
CDSCO will examine your application. For higher-risk devices (Class C & D), an inspection of the manufacturing facility may be required. - Receive CDSCO Approval
Once your application is approved, you will receive a registration certificate. This certificate allows legal manufacturing, import, and distribution of the device in India.
7. Ensure Ongoing Compliance
Even after approval, you must comply with CDSCO’s post-market surveillance requirements, including adverse event reporting, labeling updates, and product recalls if necessary.
Need to Import Medical Devices into India?
Foreign manufacturers looking to enter the Indian market must obtain a CDSCO import license. This involves:
- Appointing an authorized Indian agent licensed to sell or distribute in India
- Submitting joint documentation from the foreign and Indian companies
- Undergoing CDSCO review and, if required, a facility inspection
- Receiving the import license in Form MD-15 or MD-26
Note: The US FDA also issues export certificates that may support your CDSCO application.
Why Choose Operon Strategist for CDSCO Medical Device Registration?
Navigating India’s regulatory framework can be time-consuming and challenging. Operon Strategist brings deep expertise and proven experience to ensure a smooth registration process. We provide:
- Accurate classification of your device
- End-to-end preparation of technical documents
- Application submission and regulatory correspondence
- Import/export license assistance
- Ongoing compliance support
We make your CDSCO journey faster, smoother, and fully compliant—so you can focus on getting your product to market.
Contact Us Today for Expert CDSCO Registration Support
Ready to register or import your medical device in India?
Talk to our regulatory experts at Operon Strategist and simplify your CDSCO process.
📧 enquiry@operonstrategist.com
FAQs
What is the difference between voluntary and mandatory registration for medical devices in India?
Previously, only notified devices required registration, making it voluntary for others. However, CDSCO now mandates registration for all classes of medical devices, phasing it in with specific deadlines. Failing to comply may lead to import/export restrictions and legal penalties.
Can foreign manufacturers register medical devices in India without a physical presence?
Yes, but foreign manufacturers must appoint an India-based Authorized Representative (AR) or Indian Agent, who will interface with CDSCO on their behalf, hold responsibility for post-market surveillance, and assist with legal compliance.