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Medical device

An Overview of Regulations on Ultrasound Equipment Import in India

dateOct 18, 2022
timeReading Time: 4 Minutes

The Ministry of Health & Family Welfare has recently come up with a release of notification on 21 October 2020...

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Medical device

Licensing Authorities for Medical Device Product Registration in India

dateSep 27, 2022
timeReading Time: 5 Minutes

In older times, manufacturing devices were sold without any law guiding them in India. In the year 2016, a rule was...

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Medical device

Voluntary Registration of Medical Device – An Overview

dateSep 27, 2022
timeReading Time: 4 Minutes

As per the Ministry of Health & Family Welfare, there has been a recent amendment in the Medical Device Rules,...

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Medical device

Rules Relating to Predicate Device under MDR, 2017

dateSep 10, 2022
timeReading Time: 5 Minutes

A predicate device is a device that most closely resembles the medical device in terms of indications of use and te...

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Music License
Medical device

How to Obtain CDSCO Medical Devices Registration for Dialysis Machine?

dateAug 31, 2022
timeReading Time: 4 Minutes

The Dialysis or Haemodialysis machine comprises a series of osmosis membranes that act as microscopic filters and a...

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Medical device

Grant of Test License for Manufacture under MDR, 2017

dateAug 25, 2022
timeReading Time: 4 Minutes

According to the Medical Device Rules (MDR) 2017[1], a small quantity of Class A, B, C, and D medical devices can b...

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Medical device

Grant of Test License for Import under MDR, 2017

dateAug 25, 2022
timeReading Time: 5 Minutes

According to section 40 of the Medical Device Rules 2017[1], any kind of medical device or in-vitro diagnostic medi...

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Medical device

Medical Device Loan License: Conditions, Documents and Procedure

dateAug 24, 2022
timeReading Time: 5 Minutes

The Medical Devices and Rules, 2017 maintains the guidelines to provide a framework of the rules and regulations of...

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Medical device

Medical Device Classes as per Amended Rules of 2020

dateAug 24, 2022
timeReading Time: 5 Minutes

With the prevalence of Covid, on 11th February 2020, the Ministry of Health and Family Welfare issued two notificat...

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Medical device

Classification of Rehabilitation Medical Devices under the MDR, 2017

dateAug 24, 2022
timeReading Time: 2 Minutes

Recently, DCGI (Drug Controller General of India)[1] issued a notice regarding the classification of Rehabilitation...

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Medical device

When is Import of Medical Devices for Personal Use Allowed?

dateAug 23, 2022
timeReading Time: 4 Minutes

Chapter V of the Medical Device Rules 2017[1] covers rules and regulations for importing Medical Devices into India...

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Medical device

Registration of Software as Medical Device in India

dateAug 17, 2022
timeReading Time: 6 Minutes

Software as Medical Device is a very fresh topic in the medical industry in India. This outcome is triggered by the...

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Medical device

What is Form MD-14 and MD-15?

dateAug 12, 2022
timeReading Time: 4 Minutes

The Central Drugs Standard Control Organisation (CDSCO) operates under the Directorate General of Health Services,...

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Medical device

What is FORM MD-7 and FORM MD-9?

dateAug 12, 2022
timeReading Time: 3 Minutes

The Central Drugs Standard Control Organisation is the highest Indian regulatory body that oversees the production...

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