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complete procedure to meet

Complete Procedure to Meet the CDSCO License Mandate of Class C & D Non-Notified Medical Devices

Overview of the CDSCO License Mandate The Central Drugs Standard Control Organisation (CDSCO) is the regulatory body that manages medical device registration in India under the Ministry of Health & Family Welfare. The main aim of CDSCO is to ensure that medical devices are...

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Manufacturing And Product Development Support For Class A Medical Devices/IVD’s

Class A Medical Devices / IVDs – Class A medical devices / IVDs are medical equipment that has low risk to the patients and public health risks. Class A medical devices /...

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medical device grouping regulations

In the year 2017, the government of India announced that all the medical devices in India would be regulated as per Medical Device Rules-2017 (MDR-17), which gives a clear idea about the...

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All About Medical Device Authorized Agent / Representative

What Is A Medical Device Authorized Agent / Representative? To register/sell a medical device in India, a Foreign Manufacturer must grant a Power of Attorney to a person/company in India who is...

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What are CDSCO Form MD 26 and 27 and the benefits of having the import license for new medical devices?

An import license for new medical devices (Form MD 26 & MD 27) is a prerequisite for starting a business to sell or distribute medical devices. Having an import license gives a...

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Medical Devices Pertaining To Rehabilitation

The Drugs and Cosmetics Act of 1940, as well as the rules promulgated under it, govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules,...

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DCGI enlists new regulation for the classification of medical devices pertaining to Cardiovascular

The Drugs and Cosmetics Act of 1940, as well as the rules promulgated under it, govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules,...

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Why do we need import licenses for In-Vitro Diagnostics kits?

The medical devices market is growing at a fast pace along with the drug market despite all the challenges created by insufficient quality standards and other inconveniences. In India, medical devices are...

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