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The Knowledge Corner
Application Procedure for Class A and B Medical Devices
Ganesh Nair
| Updated: Sep 10, 2022 | Category: CDSCO

Application Procedure for Class A and B Medical Devices

The Central Drug Standard Control Organisation (CDSCO) released the medical device rules in the year 2017. The rules came into force in the year 2018. These rules cover all the...

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Medical Device Loan License
Ganesh Nair
| Updated: Sep 08, 2022 | Category: CDSCO

CDSCO Medical Device Loan License

The Ministry of health and family welfare (MoHFW) and the CDSCO have enacted the rules of the Medical device, 2017. The rules have been created to make sure that only...

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FORM MD-14 and MD-15
Ganesh Nair
| Updated: Sep 07, 2022 | Category: CDSCO

What is Forms MD-14 and MD-15

Central Drugs Standard Control Organisation (CDSCO) is the authority that works under the Directorate General of Health Services. CDSCO is responsible for permitting new medicines, creating rules/ regulations, monitoring the...

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FORMs COS-1 and COS-2
Ganesh Nair
| Updated: Sep 07, 2022 | Category: CDSCO

What are FORMs COS-1 and COS-2

The Directorate General of Health Services authorises the Central Drugs Standard Control Organisation to issue cosmetic goods and product licenses. The drugs and cosmetics act 1940 and cosmetics rules 2020...

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Medical Device Product Registration
Ganesh Nair
| Updated: Sep 06, 2022 | Category: CDSCO

Licensing Authorities for Medical Device Product Registration in India

The medical device industry in India is growing rapidly, and it is expected that it shall continue to do so in the coming few years. As the Indian consumer is...

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Free Sale Certificate
Ganesh Nair
| Updated: Sep 05, 2022 | Category: CDSCO

What is a Free Sale Certificate?

A free sale certificate is a document issued for the export of medical equipment/devices, cosmetics and food items. These materials are not governed under the Drugs and Cosmetics act. The...

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Medical Device
Ganesh Nair
| Updated: Sep 03, 2022 | Category: CDSCO

Registration of Software as Medical Device in India

With a view to expanding the scope of the regulations related to 'medical devices,' the government released a notification in the year 2020. This comes after the government introduced the...

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Notified & Non-Notified Medical Devices
Ganesh Nair
| Updated: Sep 02, 2022 | Category: CDSCO

Difference between Notified & Non-Notified Medical Devices

CDSCO stands for Central Drugs Standard Control organisation. This entity is responsible for the regulation of drugs in India. CDSCO works under the ambit of the Directorate General of health...

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CDSCO Approval
Ganesh Nair
| Updated: Sep 01, 2022 | Category: CDSCO

CDSCO Approval for Voluntary Registration of Medical Devices

In India, the regulation of medical devices is carried out by the Central Drugs Standard Control Organisation (CDSCO). The government authority has enlisted around 37 medical devices as per the...

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CDSCO Medical Devices
Ganesh Nair
| Updated: Aug 27, 2022 | Category: CDSCO

Manufacturing Registration for CDSCO Medical Devices

India is one of the biggest exporters of medical devices in the world. Earlier, there were laws to regulate medical devices in India. After 2006, The medical devices circulating in...

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