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CDSCO Registration for Medical Devices/ IVD
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Overview of -CDSCO Registration for Medical Device/IVD
CDSCO Registration is the process of getting approval from the Central Drugs Standard Control Organization (CDSCO) to import, manufacture, and sell medical devices, including in-vitro diagnostics (IVDs) in India. It is also known as Medical Device Registration. CDSCO Registration is also needed for cosmetics, drug manufacturing, and import as well. 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 is the best CDSCO License Consultant in India. We help business meet all regulatory requirements so they can import, manufacture & Sell medical device in India.
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What is Medical Device Registration?
Medical Device Registration is a regulatory process that includes the submission of information and documents to a government agency and regulatory authority (like the FDA in the U.S. or the European Medicines Agency in the EU). The process is done to obtain approval or authorization to market and distribute medical devices in a particular jurisdiction. It is necessary to ensure safety, efficacy, and quality standards.
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Classification of Medical Devices
Medical devices in India are classified into four categories based on the risk they pose to the patient:
Benefits Of Medical Device Registration
Legal Compliance
It ensure that your products meets the health regulations. This helps you to avoid the legal troubles and fines. Allows you to sell your devices legally.
Market Access
Expand the market with the registered devices. You can easily sell your products in more countries to reach a wider audience. This results in more business and sales opportunities.
Credibility and Competitive Advantage
Registration of the medical devices shows that product is safe and reliable. This builds trust with doctors, patients, and consumers, making your products more attractive compared to unregistered competitors.
What is the Purpose of Medical Device Registration
Here’s a brief overview of the purpose of Medical Device Certificate:
- 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 Registration?
- 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
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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
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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
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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 Medical Device License In India?
Yes, you need a Medical Device License in India if you want to import, manufacture, or sell medical devices or in-vitro diagnostics (IVDs). Medical Device Certificate is issued by the CDSCO (Central Drugs Standard Control Organization). It make sure your products meet the safety, quality, and regulatory standards required under Indian law.
Who Can Submit A Form For Medical Device Certificate?
A Manufacturers, importers, and authorized representatives (for foreign manufacturers) can submit a form for a Medical Device License in India.
How Much Time Does It Take To CDSCO Registration??
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
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