India’s healthcare industry is growing rapidly, and with it, the demand for quality medical devices is also on the rise. Whether you are a domestic manufacturer or an international supplier, if you want to launch a medical device in India, the first and most important step is getting approval from CDSCO—the Central Drugs Standard Control Organization.

In this blog, we’ll break down everything you need to know about CDSCO approval, the process of Medical Device Registration in India, and how Corpbiz can guide you every step of the way.

What is CDSCO?

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory body for pharmaceuticals and medical devices. It functions under the Ministry of Health and Family Welfare and ensures that drugs and medical devices sold in India are safe, effective, and meet quality standards.

If you're planning to launch a medical device in India, you must obtain approval or registration from CDSCO. Without it, you cannot legally manufacture, import, or sell your product in the country.

 Why CDSCO Approval is Important for Medical Devices?

1. Legal Compliance: CDSCO approval is mandatory under the Drugs and Cosmetics Act, 1940.
   
   

2. Consumer Safety: It ensures that your device meets health and safety standards.
   
   

3. Market Access: Without CDSCO registration, you can’t sell your device in the Indian market.
   
   

4. Credibility: It increases brand trust and opens doors to hospitals, clinics, and government tenders.
   
   

5. Export Opportunities: CDSCO approval can also strengthen your case when exporting from India.
   
   

Who Needs CDSCO Approval?

You need CDSCO approval if you fall under any of the following categories:

• Indian medical device manufacturers
  
  

• Importers of foreign medical devices
  
  

• Distributors acting on behalf of international brands
  
  

• Anyone involved in the sale or marketing of medical devices
  
  

Classification of Medical Devices

CDSCO has classified medical devices into four categories based on risk:

• Class A: Low risk (e.g., thermometers)
  
  

• Class B: Low to moderate risk (e.g., surgical gloves)
  
  

• Class C: Moderate to high risk (e.g., infusion pumps)
  
  

• Class D: High risk (e.g., heart valves)
  
  

Note: The higher the class, the more rigorous the approval process.

Documents Required for CDSCO Registration Online

To apply for CDSCO Registration Online, you’ll need:

• Manufacturing license (for Indian manufacturers)
  
  

• Free Sale Certificate (for importers)
  
  

• Device Master File (DMF)
  
  

• ISO 13485 certificate
  
  

• Undertaking from the manufacturer
  
  

• Power of Attorney (if applicable)
  
  

• Test reports and clinical evaluation reports
  
  

• Labels and package inserts
  
  

• Technical documents and risk analysis
  
  

Step-by-Step CDSCO Medical Device Registration Process in India

Here’s how to register your medical device with CDSCO:

1. Device Classification

Identify your device category (Class A to D).

2. Appoint an Authorized Indian Agent (for foreign manufacturers)

An Indian agent is mandatory for all foreign companies importing into India.

3. Prepare Technical Documents

Gather necessary files like ISO certification, test reports, and DMF.

4. Apply Online

Submit your application on the CDSCO SUGAM portal.

5. Review and Queries

CDSCO may ask for clarifications. Respond promptly.

6. Inspection and Evaluation

For higher-class devices, CDSCO may inspect the manufacturing facility.

7. Grant of Registration

Once all is verified, the device will be registered, and you’ll receive a registration certificate.

CDSCO Registration Online with Corpbiz

At Corpbiz, we help businesses simplify regulatory hurdles. Whether you are applying for CDSCO registration online, a Cosmetic Manufacturing License Registration, or a Drug License Registration, our experts handle everything for you—from documentation to follow-ups.

Why Choose Corpbiz?

• 1000+ successful CDSCO registrations
  
  

• Dedicated legal and technical teams
  
  

• End-to-end support from application to approval
  
  

• Transparent pricing and timely service
  
  

Related Licensing Services We Offer

While working with medical devices, you may also need other licenses:

1. Cosmetic Manufacturing License Registration

If your business involves cosmetic items like creams, lotions, or personal care products, a cosmetic manufacturing license under CDSCO is required.

2. Drug License Registration

If your business deals with drugs, medicines, or APIs (active pharmaceutical ingredients), obtaining a drug license is mandatory.

FAQs

Q1. Is CDSCO registration mandatory for all medical devices?
Yes, registration is mandatory for all notified medical devices before they are manufactured or sold in India.

Q2. Can I apply for CDSCO registration online?
Yes, applications must be submitted through the CDSCO SUGAM online portal.

Q3. What is the validity of CDSCO medical device registration?
Typically, the registration is valid for 3 years unless otherwise mentioned.

Q4. How long does the CDSCO approval process take?
Depending on the class of the device, it may take between 2 to 6 months.

Q5. Can Corpbiz help with cosmetic or drug license registration too?
Absolutely! Corpbiz offers expert services for Cosmetic Manufacturing License Registration and Drug License Registration.

Final Thoughts

Getting CDSCO approval is not just a formality—it’s a crucial step that proves your medical device is safe, reliable, and compliant with Indian regulations. The approval opens doors to India’s fast-growing healthcare market and builds trust with consumers.

With a trusted partner like Corpbiz, your journey to launching a medical device in India becomes smooth, fast, and stress-free. From CDSCO Registration Online to Drug and Cosmetic Licenses, we are your one-stop solution for regulatory compliance.

Author:
Atul Shukla
Regulatory Expert, Corpbiz
Helping businesses comply, grow, and innovate in India’s regulated markets.