CDSCO Registration in India for Medical Devices/ IVD
Welcome to ELT Corporate – Your Trusted Partner for CDSCO Registration and Medical Device Certification.
- Quick Response
- Easy Registration Process
- Complete Online Process
- Free Documentation Review
Book Free Consultation
Overview of CDSCO Registration for Medical Device/IVD
CDSCO registration is a approval from the side of the Central Drugs Standard and Control Organization. The CDSCO is the national regulatory authority responsible for ensuring the safety, efficacy, and quality of medical devices and in vitro diagnostic (IVD) products in India. Under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, medical devices and IVDs are regulated to safeguard public health.
ELT Corporate makes getting CDSCO registration in India easy and straightforward. We help companies meet all regulatory requirements so they can enter the Indian market smoothly.
Types of CDSCO Registration We Provides
Medical Device Registration
Cosmetics Registration
What is the Purpose of CDSCO Registration
- Ensure Product Safety
- Maintain Quality Standards
- Protect Public Health
- Support Ethical Practices
- Streamlined Regulatory Compliance
- Facilitate Market Access
- Enhance Consumer Confidence
- Promote Regulatory Compliance
- Enable Post-Market Surveillance
Who Can Apply For CDSCO License In India?
- Medical Device, Drug & Cosmetic Manufacturers
- Medical Device, Drug & Cosmetic Importers
- Foreign Enterprise Holding Indian Subsidiary
- Distributors, Wholesalers, and Retailers of Drugs & Medical Devices
- Authorized Agents for Foreign Manufacturers
- Research and Development (R&D) Units
- Entities Holding the Rights to Market Products
- Third-Party & Contract Manufacturers
Process Of CDSCO Registration
Follow the process to apply for the CDSCO Registration In India:
- Determine if the product is under notified or not..
- In the case of a foreign entity, appoint an authorized representative.
- Fill out the form for medical device registration.
- Obtain a Certificate of Registration as prescribed.
Our Testimonials
- List Item #1
- List Item #1
- List Item #1
- List Item #1
- List Item #1
ELT Corporate’s team secured our CDSCO import licence despite the document challenges required to obtain this licence. Their efficient team guided us throughout the entire process and made it smooth for us.
Pankaj Gupta
- List Item #1
- List Item #1
- List Item #1
- List Item #1
- List Item #1
ELT Corporate helped us get our CDSCO import license even though we had a lot of complicated paperwork to handle. Their team was super efficient and guided us every step of the way, making the whole process easy.
Ahana
- List Item #1
- List Item #1
- List Item #1
- List Item #1
- List Item #1
Getting our CDSCO import license seemed impossible until we found ELT Corporate. Their knowledgeable and professional team handled all the tricky documentation for us. They made the entire process stress-free and quick.
Kiran
Frequently Asked Question
Do I Need To Register My Medical Device In India?
Yes, After October 1, 2021 every medical device need to registered. Before importing devices in India medical device import license with the CDSCO is mandatory.
Who Can Submit A Form For Medical Device License?
The manufacturer of medical devices, authorized agent or authorized representative, and importers can submit the form for the registration of CDSCO.
How Much Time Does It Take To Register MD In India?
To register Medical devices in India every product category have different time duration such as:-
- Non Notified Class C & D medical devices cab be register currently through the e-portal.
- All A & B Medical devices will typically takes 6 to 9 months for the device approval.
- Product with reference country approval takes less time and quicker review response.
How Are Medical Products Classified In India?
Medical Devices are classified into 4 categories in India accordance:-
It is devices according from low risk Class A to high risk Class D.
- Class A
- Class B
- Class C
- Class D
Address
- +91 9891-9980-02
- info@medicaldeviceregistration.com
- ELT House No. 271, Pocket D-15, Sec-3, Rohini, New Delhi-110085
Book Free Consultation
© 2024 – ELT Corporate Pvt Ltd. | All rights reserved.