Medical Regulatory Affairs Overview

<p>They are exempt from Premarket Notification and Premarket Approval. (D)</p> Signup and view all the answers

<p>47% (D)</p> Signup and view all the answers

<p>FDA General Controls. (D)</p> Signup and view all the answers

<p>They are typically fast and easy to bring to market. (B)</p> Signup and view all the answers

<p>A quality management system. (A)</p> Signup and view all the answers

<p>They present a higher risk due to sustained patient contact. (C)</p> Signup and view all the answers

<p>Pacemakers (B)</p> Signup and view all the answers

<p>Post-market surveillance (B)</p> Signup and view all the answers

<p>They are subject to the PMA process due to high risk. (C)</p> Signup and view all the answers

<p>10% (A)</p> Signup and view all the answers

<p>They may need special labeling requirements. (A)</p> Signup and view all the answers

<p>Breast implants (D)</p> Signup and view all the answers

<p>Premarket Approval (PMA). (A)</p> Signup and view all the answers

<p>Notified devices are listed in the office gazette released by the government of India. (B)</p> Signup and view all the answers

<p>Class D (B)</p> Signup and view all the answers

<p>The intended use and risk of the device. (C)</p> Signup and view all the answers

<p>A four-class system. (D)</p> Signup and view all the answers

<p>The risk level of the device. (D)</p> Signup and view all the answers

<p>Offer low risk to patients. (D)</p> Signup and view all the answers

<p>It is used in direct contact with the central nervous system. (C)</p> Signup and view all the answers

<p>Safety and effectiveness (C)</p> Signup and view all the answers

<p>The entire lifecycle of the device (B)</p> Signup and view all the answers

<p>To aid in identification and tracking of devices (D)</p> Signup and view all the answers

<p>Timely communication with healthcare professionals (A)</p> Signup and view all the answers

<p>CDSCO (A)</p> Signup and view all the answers

<p>Sales and marketing strategies (C)</p> Signup and view all the answers

<p>Establishing guidelines and standards for safety and efficacy (D)</p> Signup and view all the answers

<p>Pre-Market Approval involving rigorous testing (C)</p> Signup and view all the answers

<p>Increased patient safety and product effectiveness (B)</p> Signup and view all the answers

<p>To monitor the ongoing safety of marketed medical devices (C)</p> Signup and view all the answers

<p>Promotional Campaigns (D)</p> Signup and view all the answers

<p>By establishing and enforcing quality system regulations (B)</p> Signup and view all the answers

<p>Potential product recalls or fines (D)</p> Signup and view all the answers

<p>Post-Market Surveillance (B)</p> Signup and view all the answers

<p>Marketing strategies (D)</p> Signup and view all the answers

<p>Assessing compliance with quality standards (D)</p> Signup and view all the answers

<p>To ensure compliance with medical regulations (B)</p> Signup and view all the answers

<p>Conduct medical research directly (B)</p> Signup and view all the answers

<p>Central Drugs Standard Control Organization (C)</p> Signup and view all the answers

<p>EMA (A)</p> Signup and view all the answers

<p>Risk-based classification (A)</p> Signup and view all the answers

<p>Device classification is influenced by intended use and risk. (C)</p> Signup and view all the answers

<p>Pharmaceutical agents for disease treatment (A)</p> Signup and view all the answers

<p>Testing performed outside a living organism (B)</p> Signup and view all the answers

<p>Achieve intended action mainly by metabolic means (A)</p> Signup and view all the answers

<p>To diagnose and treat diseases (D)</p> Signup and view all the answers

Groups that set the rules and standards for making, selling, and using medical devices.

Creating the laws and guidelines that medical device companies must follow.

Checking a medical device BEFORE it goes to market to ensure safety and effectiveness.

Tracking medical devices AFTER they are being used to see if there are any problems.

Setting rules for how medical device companies must operate to guarantee quality.

Visiting medical device companies to make sure they are following the rules.

Medical devices categorized by the FDA based on their risks and the regulatory controls required to ensure safety and effectiveness.

Medical devices that pose the lowest risk to patients and users.

Class I devices, like electric toothbrushes, do not require premarket notification or approval.

FDA regulations that apply to all classes of medical devices.

Class I medical devices have these general controls, such as quality management standards and good manufacturing practices.

Medical devices that pose a higher risk than Class I, but less than Class III.

Medical devices that pose the highest risk to patients and users.

Class III devices require a rigorous approval process, involving premarket approval (PMA) and extensive testing.

Regulatory Affairs ensures that medical devices meet all legal and safety standards.

The FDA is the US agency responsible for overseeing the safety and efficacy of medical devices.

The EMA is the European Medicines Agency. It's responsible for evaluating the safety and effectiveness of medicines and some medical devices.

The CDSCO is the Central Drugs Standard Control Organization in India. It plays a vital role in regulating the quality and safety of medical devices.

The CDSCO is responsible for ensuring that medical devices are safe, effective, and of good quality. This includes setting and enforcing standards, issuing licenses, and monitoring devices after they are in use.

The classification system categorizes medical devices based on their potential risk to the patient. Higher risk devices require more stringent regulations.

Medical devices are grouped into different classes according to their intended use and associated risks.

Different classes of medical devices have specific regulatory requirements. These requirements ensure that devices meet appropriate safety and performance standards.

The GHTF (Global Harmonization Task Force) is a group of international bodies aiming to simplify the regulation of medical devices.

A medical device designed to treat or prevent diseases, help with injury recovery, modify the body's function or structure, and support life.

Medical devices that require more stringent controls due to potential for prolonged patient contact and higher risk of complications.

Devices that are considered to be the safest and least complex. They typically have minimal contact with the patient and pose lower risks.

Medical devices that are considered the most complex and risky, requiring the most stringent regulations. They often sustain or support life, are implanted, or pose a high risk of illness or injury.

Regulations that apply to all medical devices regardless of their classification. These are basic requirements for safety and effectiveness.

Specific regulations that apply to Class II devices, depending on the specific device. These may include special labeling, performance standards, and patient registries.

The process by which Class III medical devices are rigorously evaluated for safety and effectiveness before they can be marketed.

A type of post-market surveillance that involves collecting and analyzing data from patients who use the device.

Medical devices categorized based on their intended usage and associated risks. They are classified into four classes (A, B, C, and D) with increasing risk levels.

Medical devices regulated by the CDSCO in India and listed in the office gazette.

Medical devices that are not mentioned in the CDSCO's list of notified medical devices.

The level of regulatory control and premarket submission required for a medical device depends on its risk level.

The regulatory authority's assessment of a device's potential harm to patients based on intended usage and attributes.

The process by which medical devices are categorized based on their risk levels.

Gathering and analyzing evidence to show that a medical device is both safe and effective for its intended use. This includes extensive clinical trials and testing.

A comprehensive system that ensures all aspects of a medical device's life cycle are managed and controlled, from design to distribution. This involves documenting processes and continuously seeking improvements.

A unique identification code assigned to each medical device. This code helps track the device throughout its journey, from manufacturing to use in a hospital, aiding in identifying problems and recalling devices if needed.

A system that proactively monitors medical devices after they are on the market to detect and address any potential safety concerns or adverse events. It involves analyzing data, managing risks, and quickly communicating with relevant parties.

The official organization responsible for regulating medical devices within a specific country or region. They set the rules and standards that device manufacturers must follow.

Categorizing a medical device based on its potential risk to patients. Devices with higher risks require more stringent regulations and review before being allowed on the market.

The process through which a manufacturer makes a medical device available for sale in a specific market. This often involves submitting applications, providing documentation, and obtaining approval from the regulatory body.

Controlled studies conducted to evaluate the safety and effectiveness of a medical device before it is released to the market. These studies are often required by regulatory bodies.