Indian Medical Device Rule, 2017 Overview

15 Questions

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

To introduce a separate regulatory framework for medical devices

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

By assessing the primary mode of action of the product on the human body

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

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

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

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

What is the purpose of the Devices Rules in India?

To harmonize Indian norms with international medical device regulations

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

International Medical Device Regulators Forum

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

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

Examination gloves

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

Before 1 January 2018

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

Moderate-to high-risk devices

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

Central Licensing Authority

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

In perpetuity

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

Central Licensing Authority

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

Manufacturers categorize devices

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.

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.

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