A Practical Guide to Medical Device Registration in India Through CDSCO Registration and CDSCO License

India’s medical device market is growing rapidly, driven by innovation, healthcare expansion, and regulatory clarity. To legally manufacture, import, or sell medical devices in India, businesses must comply with the regulations issued by the Central Drugs Standard Control Organization (CDSCO). This makes cdsco registration, medical device registration, and obtaining a valid cdsco license essential steps for market entry and long-term compliance.

Understanding CDSCO and Its Role

CDSCO is the national regulatory authority responsible for regulating drugs and medical devices in India under the Drugs and Cosmetics Act and the Medical Devices Rules, 2017. It ensures that medical devices available in the Indian market meet safety, quality, and performance standards.

Any manufacturer or importer of notified medical devices must complete cdsco registration before commercial distribution. Without proper approval, products cannot be legally marketed or sold.

What is Medical Device Registration?

Medical device registration refers to the process of notifying and registering your medical device with CDSCO through the official online portal. Devices are classified into four risk categories:

• Class A (low risk)

• Class B (low to moderate risk)

• Class C (moderate to high risk)

• Class D (high risk)
  

The classification determines the level of regulatory scrutiny and the approving authority. Lower-risk devices are regulated by State Licensing Authorities, while higher-risk devices are regulated directly by CDSCO.

CDSCO License: Why It Matters

A cdsco license is the formal approval that authorises a company to manufacture or import a medical device in India. There are different types of licences, such as:

• Manufacturing licence (Form MD-5 or MD-9)

• Import licence (Form MD-15)
  

Holding a valid CDSCO licence ensures your products meet Indian regulatory standards and protects your business from penalties, product recalls, or legal action.

Step-by-Step Overview of the Process

1. Device Classification – Identify the correct risk class of your medical device.

2. Entity Registration – Register the company on the CDSCO online portal.

3. Document Preparation – Prepare technical files, device master file, plant master file, and quality certifications.

4. Application Submission – Submit the application for cdsco registration or licence through the portal.

5. Review & Approval – The authority reviews documents and may ask for clarifications. Once approved, the cdsco license is issued.
   

How ASC Group Supports Your Compliance Journey

ASC Group provides structured advisory and execution support for cdsco registration and medical device registration in India. From identifying the correct device classification to preparing regulatory documentation and coordinating with authorities, ASC Group helps businesses navigate compliance efficiently and accurately.

Whether you are an Indian manufacturer, a foreign exporter, or a healthcare startup, ASC Group ensures that your application process is aligned with regulatory requirements, reducing delays and compliance risks.

Final Thoughts

Medical device compliance is not just a regulatory formality — it is a critical step toward building credibility, market trust, and long-term business sustainability in India. Proper medical device registration, timely cdsco registration, and maintaining a valid cdsco license enable companies to operate legally and confidently in the healthcare ecosystem.

With professional guidance from ASC Group, businesses can simplify regulatory complexity and focus on delivering safe, innovative medical solutions to the Indian market.