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Questions and Answers
What is the main purpose of the Medical Devices Rules, 2017 in India?
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?
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?
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?
What impact does a higher-risk classification have on the regulatory procedures for medical devices?
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?
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?
What is the purpose of the Devices Rules in India?
What is the purpose of the Devices Rules in India?
Which organization's guidelines serve as a basis for the Devices Rules in India?
Which organization's guidelines serve as a basis for the Devices Rules in India?
How many categories are medical devices classified into under the Devices Rules?
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?
Which of the following is an example of a Class A medical device based on the risk classification?
When is it expected that a new set of medical devices would be notified under the Devices Rules?
When is it expected that a new set of medical devices would be notified under the Devices Rules?
Which type of medical devices are classified under Class C according to the text?
Which type of medical devices are classified under Class C according to the text?
Who has the authority to categorize medical devices under the Devices Rules?
Who has the authority to categorize medical devices under the Devices Rules?
What is the term used in the text to describe the permanence of licenses issued to manufacturers and importers?
What is the term used in the text to describe the permanence of licenses issued to manufacturers and importers?
Where should applications for the manufacture of Class D medical devices be presented according to the Devices Rules?
Where should applications for the manufacture of Class D medical devices be presented according to the Devices Rules?
What is the primary difference highlighted between the GHTF Guidelines and Devices Rules in terms of categorizing medical devices?
What is the primary difference highlighted between the GHTF Guidelines and Devices Rules in terms of categorizing medical devices?
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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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