Medical Device Registration In India – Apply Online

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Reach out to ELT Corporate for expert support and get assured Medical Devices compliance for both domestic and international markets.
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  • Over 2500 regulatory licenses obtained quickly.
  • Credible memberships with major industry associations.
  • Transparent and proactive communication.

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Medical Device Manufacturer License

Ensure your devices meet compliance standards. Apply now for Manufacturer Registration!

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Medical Devices Import License

Start importing with confidence. Secure your Medical Device Importer Registration today!

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Free Sale Certificate

Expand your reach into new markets. Get your Free Sale Certificate now!

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Non Conviction Certificate

Build trust with regulatory bodies. Secure your Non Conviction Certificate today!

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Market Standing Certificate

Demonstrate your business's reliability. Apply for a Market Standing Certificate today!

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CDSCO Registration

Navigate the regulatory landscape smoothly. Apply for CDSCO Registration now!

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About ELT Corporate

At ELT Corporate Pvt Ltd, we are experts in medical device registration in India, ensuring compliance with CDSCO standards under the Ministry of Health & Welfare.

Our team comprises skilled attorneys, scientists, engineers, and regulatory professionals who have facilitated over 2500+ regulatory licenses with expedited efficiency.

As trusted members of AIMED, ASSOCHAM, FICCI, and ICC, we emphasize transparent communication and a proactive approach. Trust us to guide your medical device compliance every step of the way.

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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. 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.

Classification of Medical Devices

Medical devices in India are classified into four categories based on the risk they pose to the patient:

Surgical Dressings, Tongue Depressors

Hypodermic Needles, Suction Equipment

Lung Ventilators, Bone Fixation Plates

Heart Valves, Implantable Defibrillators

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.

Documents For Medical Device Registration

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Who Can Apply for CDSCO Registration in India?

  • Domestic Manufacturers of Medical Devices/IVDs

  • Importer of Medical Devices/IVDs/Cosmetics

  • Foreign Manufacturer of Medical Devices/IVDs/Cosmetics

  • Indian Subsidiary of Medical Devices/IVDs/Cosmetics

  • Authorised Agent of Medical Devices/IVDs/Cosmetics

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Process Of Medical Device Registration

Step 1

Contact us via call or form

Step 2

Provide Documents

Step 3

Get your certificate

Trusted By People Like You

At ELT Corporate PVT Ltd, we are dedicated to ensuring compliance and excellence. Our commitment drives positive outcomes and superior results for our clients.

MDR Review Testimonial

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.

Ahana Review

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.

Pankaj Gupta

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

Frequently Asked Questions

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.

The manufacturer of medical devices, authorized agent or authorized representative, and importers can submit the form for the registration of CDSCO.

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.

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

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