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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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Rational fixed dose combinations (FDCs), also known as combination products, are the integration of two or more drugs in a single dosage form. The Food and Drug Administration (FDA), USA defines a...

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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 The Cosmetic Regulations in India for Cosmetic License Approval

According to the Drugs and Cosmetics Act, 1940, and New Cosmetics Rules 2020 and the Rules enacted thereunder, the State Drug Control Department inspects and grant cosmetic license approval for importers and...

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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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How To Get Wholesale Drug Licenses In India?

Wholesale Drug License In India - Overview The pharmacy business in India is booming. To ensure consumer safety, the Government keeps changing guidelines that aid streamlining of the processes as well. To...

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