Indian Medical Device Rule, 2017 Overview

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Questions and Answers

What is the main purpose of the Medical Devices Rules, 2017 in India?

To introduce a separate regulatory framework for medical devices (correct)

To streamline the regulations for food products under the Drugs Act

To redefine the classification of drugs under the Drugs Act

To regulate the import of medicinal products under the Drugs Act

How will regulators determine whether a product falls under the drug or medical device category?

By considering if the product contains any pharmaceutical ingredients

By examining if the product is used for clinical trials

By assessing the primary mode of action of the product on the human body (correct)

By evaluating if the product is imported or manufactured domestically

What distinguishes a medical device from a drug, as per the Devices Rules?

Medical devices are always imported while drugs are manufactured domestically

Medical devices achieve their primary intended action without pharmacological, immunological, or metabolic means (correct)

Medical devices act on the human body through pharmacological means

Medical devices are used for clinical trials, while drugs are not

What impact does a higher-risk classification have on the regulatory procedures for medical devices?

It leads to more regulations and a stringent conformity assessment process Signup and view all the answers

Which chapter of the Medical Devices Rules, 2017 is likely to cover guidelines related to Clinical Investigation of Medical Device and Clinical Performance Evaluation of new In Vitro Diagnostic?

Chapter VII - Clinical Investigation of Medical Device and Clinical Performance Evaluation of new In Vitro Diagnostic Signup and view all the answers

What is the purpose of the Devices Rules in India?

To harmonize Indian norms with international medical device regulations Signup and view all the answers

Which organization's guidelines serve as a basis for the Devices Rules in India?

International Medical Device Regulators Forum Signup and view all the answers

How many categories are medical devices classified into under the Devices Rules?

4 Signup and view all the answers

Which of the following is an example of a Class A medical device based on the risk classification?

Examination gloves Signup and view all the answers

When is it expected that a new set of medical devices would be notified under the Devices Rules?

Before 1 January 2018 Signup and view all the answers

Which type of medical devices are classified under Class C according to the text?

Moderate-to high-risk devices Signup and view all the answers

Who has the authority to categorize medical devices under the Devices Rules?

Central Licensing Authority Signup and view all the answers

What is the term used in the text to describe the permanence of licenses issued to manufacturers and importers?

In perpetuity Signup and view all the answers

Where should applications for the manufacture of Class D medical devices be presented according to the Devices Rules?

Central Licensing Authority Signup and view all the answers

What is the primary difference highlighted between the GHTF Guidelines and Devices Rules in terms of categorizing medical devices?

Manufacturers categorize devices Signup and view all the answers

Study Notes

Indian Medical Device Industry

India is one of the largest markets for medical devices in the world.
There are over 800 medical devices manufacturers in India.

Characteristics of Indian Medical Device Manufacturers

Close to 65% of companies have a turnover of over INR 10 crore (USD 1.5 million).
2% of companies have a turnover of more than INR 500 crore (USD 73 million).

Dependence on Imported Products

Imported products comprise around 70% of total sales in the medical device market.
Domestic companies are largely involved in manufacturing consumables and low-end products for local and international consumption.

Government Initiatives

The Government has permitted 100% FDI in the medical devices sector.
The Government has corrected the inverted duty structure for certain medical devices.
Inverted duty structure impacts the domestic industry adversely as inputs and raw materials are taxed at a higher rate than import duty on finished products.

Establishment of Med Tech Parks

Three Med Tech Parks are being set up in Andhra Pradesh, Maharashtra, and Gujarat.
The major purpose of these Med Tech Parks is to reduce the cost of production or manufacturing.
These parks will have in-house common manufacturing facilities and consolidate raw material procurement.

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Description

Learn about the Indian Medical Device Rule, 2017 and the landscape of medical device manufacturing and consumption in India. Discover key statistics, market dynamics, and the dominance of imported products in the Indian medical device market.