CDSCO Registration for Medical Devices
If you are a medical device manufacturer or exporter based in the Netherlands and planning to supply your products to India, obtaining CDSCO registration is a mandatory regulatory requirement. The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices for the Indian market. Operon Strategist assists manufacturers and their Indian importers in navigating the complete CDSCO licensing process, from documentation to submission, ensuring full regulatory compliance for smooth market entry and legal distribution in India.
What is CDSCO Registration?
CDSCO registration is the mandatory regulatory approval granted by India’s Central Drugs Standard Control Organization for medical devices intended for import, manufacture, or sale in the Indian market. CDSCO ensures that all medical devices meet India’s required safety, quality, and performance standards. Manufacturers must classify their devices correctly, prepare comprehensive technical documentation, and comply with CDSCO’s regulatory framework.
For medical device manufacturers and exporters in the Netherlands, securing CDSCO registration is essential for legal distribution and smooth market access in one of the world’s fastest-growing healthcare markets.
What are the Objectives of CDSCO?
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority responsible for medical device oversight. Its primary objective is to ensure that all medical devices marketed in India are safe, effective, and compliant with quality standards.
Key Objectives of CDSCO:
- Ensure the safety, efficacy, and quality of medical devices sold in India
- Regulate the import, manufacture, and distribution of devices through proper licensing
- Enforce Good Manufacturing Practices (GMP) and other quality standards
- Conduct post-market surveillance to monitor device safety and performance
- Oversee clinical trials and investigations for medical devices
- Facilitate compliant import/export procedures for global trade
- Promote alignment with international regulatory standards
- Educate stakeholders on safe and compliant device usage
- Collaborate with global regulators for harmonized best practices
- Improve approval processes and reduce regulatory timelines
For manufacturers and exporters in the Netherlands, understanding CDSCO’s role is essential to achieving smooth, legal market entry into India’s growing healthcare sector.
What is Classification of Medical Devices as per CDSCO:
MDR 2017 has categorized the devices as Class A, Class B, Class C and Class D. Below table will spread some light on classification of medical devices.
Type | Risk | Example |
Class A | Low Risk | Bandage, examination loves etc. |
Class B | Low-Medium Risk | B.P. monitoring device, thermometer |
Class C | Moderate to High Risk | Implants, catheter |
Class D | High Risk | Heart valve. |
CDSCO Import License – A Must for Supplying Medical Devices to India
If you are a medical device manufacturer or exporter in the Netherlands aiming to enter the Indian market, obtaining a CDSCO Import License is a mandatory regulatory requirement. Issued by the Central Drugs Standard Control Organization (CDSCO), this license ensures that your imported devices meet the safety, quality, and performance standards set under the Drugs and Cosmetics Act, 1940.
CDSCO Import License Requirements
Effective from 1st October 2022:
- Mandatory for all Class A and B medical devices
- Mandatory for all notified Class C and D medical devices
Effective from 1st October 2023:
- Mandatory for all non-notified Class C and D devices
- Previously, these devices were subject to voluntary registration until 30th September 2023
Step-by-Step Process to Register Medical Devices in India
Operon Strategist supports medical device manufacturers and exporters in the Netherlands through the complete CDSCO registration process, ensuring fully compliant and efficient market access to India’s growing healthcare sector.
1. Classify Your Medical Device
Determine the risk class (A, B, C, or D) based on intended use and CDSCO’s classification rules under Indian medical device regulations.
2. Prepare Technical Documentation
Compile required files such as:
- Device Master File (DMF)
- Plant Master File (PMF)
- Test reports and clinical data
- ISO 13485 certificate
3. Appoint an Indian Authorized Agent
Designate a licensed Authorized Representative (AR) in India to manage communications and submissions with CDSCO on your behalf.
4. Submit Application via SUGAM Portal
Create an account and file your application through CDSCO’s SUGAM online portal, attaching all required documentation and proof of fee payment.
5. CDSCO Review & Query Handling
Respond promptly to any CDSCO queries or requests for clarification to avoid delays.
6. Facility Inspection (for Class C & D Devices)
Higher-risk devices may undergo CDSCO facility inspection to verify compliance with Indian GMP and ISO 13485 standards.
7. Grant of License
Upon approval, CDSCO issues the Import License or Manufacturing License, authorizing you to legally enter the Indian market.
8. Post-Market Surveillance
Ensure ongoing compliance through adverse event reporting, device recalls (if needed), and regulatory updates.
Why CDSCO Registration is Important
CDSCO registration is a legal requirement for placing medical devices on the Indian market. Without it, manufacturers and exporters cannot import, distribute, or sell their products in India. The process ensures that all devices meet India’s safety, quality, and performance standards under the Drugs and Cosmetics Act, 1940.
Key Reasons CDSCO Registration Matters:
- Mandatory for Market Access in India
- Ensures Compliance with Indian regulatory requirements
- Builds Trust with healthcare providers and buyers
- Prevents Regulatory Penalties and import restrictions
- Aligns with Global Quality Systems like ISO 13485
- Enables Long-Term Growth in one of the world’s fastest-growing healthcare markets
Whether you’re a manufacturer in the Netherlands or a global exporter, CDSCO approval is essential for legal, safe, and successful business in India.
Operon Strategist Helps Netherlands-Based Manufacturers Enter the Indian Market via CDSCO
At Operon Strategist, we simplify CDSCO registration for Netherlands-based medical device manufacturers and exporters looking to enter the Indian market. From accurate device classification and documentation to seamless SUGAM portal submissions and post-approval compliance, we manage the entire process with precision.
Our strategic approach reduces delays and ensures your devices meet India’s regulatory standards. But our support doesn’t stop at CDSCO we’re your global regulatory partner. Whether it’s CE Marking under EU MDR, US FDA 510(k), or registrations with SFDA, SAHPRA, or EDA, we deliver fast, compliant market access.
We also specialize in turnkey project consulting, plant layout design, validation, and feasibility analysis helping you expand with confidence and regulatory peace of mind.
Ready to Export Medical Devices to India? Let Operon Strategist Guide Your CDSCO Compliance.
FAQs
What is CDSCO registration and why is it important for Dutch manufacturers?
CDSCO registration is a mandatory approval process by India's Central Drugs Standard Control Organization. It ensures that imported medical devices meet Indian safety, quality, and performance standards. Netherlands-based manufacturers need this license to legally distribute or sell medical devices in India.
Which classes of devices require CDSCO import licensing?
As of October 2023, CDSCO import licenses are required for all Class A, B, C, and D medical devices—both notified and non-notified. Earlier voluntary registration has now been replaced with mandatory licensing.
What documents are needed for CDSCO registration?
Key documents include the Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificate, test reports, clinical evaluation data, Free Sale Certificate (FSC), and details of the Authorized Indian Agent.
Can Operon Strategist help with the CDSCO registration process?
Yes, Operon Strategist offers complete CDSCO support—device classification, documentation, SUGAM portal submissions, query handling, and post-approval compliance for Netherlands-based exporters.
How long does the CDSCO registration process take?
The timeline can vary by device class and documentation quality. On average, Class A/B devices may take 3–6 months, while Class C/D may take 6–9 months due to additional inspections and evaluations.