Apply For Medical Device Registration In India

CDSCO is known as the Central Drugs Standard Control Organisation. Under the provisions of the Drugs & Cosmetics Rules CDSCO is a regulatory body for the Indian medical devices industry.

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About ELT Corporate

ELT Corporate Private Limited is a legal consultant company trusted by many clients around many countries. Among the multiple services we are also specialized in providing the medical device registration consultant provider. The services are related to Medical Law, Medical Device Rules 2017 newly emerged in society. We are medical consultant providing all the services that required to register medical devices to our client. Services like documentation preparing, legal, brief laws to our clients, technical parameters of medical rules 2017. 

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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.

Medical devices include a wide range of products such as diagnostic equipment, surgical instruments, implantable devices, in vitro diagnostic devices, and more.

The medical device registration is necessary because medical devices on the market need certain safety, efficacy, quality standards, and they are approximately labelled and manufactured. The medical device registration process varies from country to country and is governed by national and international regulations.

Process Of Medical Device Registration

Process of CDSCO certificate registration is not a very easy task. But here ELT Corporate team will help you in:-

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Process Of Medical Device Registration

Frequently Asked Questions

If you are still thinking about CDSCO registration medical device certification or licensing then we are here to find out better solution for you. Our team makes all efforts to solve any kind of query on time.

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. 

Can I Stay With My Loved Ones On Holidays?

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

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