To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
IMPLANTS
MEDICAL DEVICES
REGULATIONS IN INDIA
CLASSIFICATION OF MEDICAL DEVICES{CDSCO, FDA}
IMPLANTS
CLASSIFICATION OF IMPLANTS
IMPLANTABLE MEDICAL DEVICES
RISKS RELATED TO IMPLANTS
ADVANTAGES & DISADVANTAGES
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
A regulatory strategy is critical to the commercialization of biomedical technologies. In particular, technologies such as new drugs and medical devices have more regulatory needs, and the strategy should be considered simultaneous to a commercialization pathway.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
1. UNIT -1 (MRA 201T)
MEDICAL DEVICES AND IVD’S
Presented by:
Ms.Bhanu Mounika
Reg. No.: 222310
I. M. Pharmacy
Shri Vishnu College of Pharmacy
Under the Guidance of:
Dr. Lakshmi Prasanthi Nori
Professor
Department of Regulatory Affairs
2. DEFINITION:
As per CDSCO,
A medical device is an apparatus, appliance,
software material, or other article whether
used alone or in combination, including the
software intended by its manufacturer to be
used specifically for diagnostic or
therapeutic purposes and necessary for its
proper application.
Medical Devices
3. As Per US FDA
1. An instrument, apparatus, implement, machine, implant, reagent, or
other similar or related article, including a component part or
accessory which is recognized in the official National Formulary, or
the United States Pharmacopoeia, or any supplement .
2. Intended for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of disease, in man or
other animals.
4. Risk Based Classification In Accordance To CDSCO
CLASS RISK LEVEL EXAMPLES
A Low Bandages , Tongue depressors
B Low - Moderate Hypodermic Needles , suction equipment
C Moderate - High Lung ventilator , Bone fixation plate
D High Heart valves , Implantable defibrillator
5. CLASS RISK LEVEL EXAMPLE
I Low Bandages , tongue depressors
II Moderate Nebulizers
III High Pacemakers , Intra ocular lenses
Risk Based Classification in Accordance to
USFDA
6. Risk Based Classification in Accordance to EU
CLASS RISK LEVEL EXAMPLE
I Low Surgical Guaze, Wheelchairs
IIa Moderate Hearing aids, Ultrasound equipment
IIb Potential high risk Infusion pumps, Surgical Lasers
III High risk Stunt-grafts, Prosthetic joints
7. IN VITRO DIAGNOSTIC DEVICES
DEFINITION:
As per CDSCO,
1. A device intended by the manufacturer
for the In-vitro examination of specimens
derived from the human body solely or
principally to provide information for
diagnosis, monitoring or compatibility
purposes.
2. This includes reagents, calibrators,
control materials, specimen receptacles,
software, and related instruments
8. In simple words, IVDs are medical devices used to perform
tests on samples, such as blood, urine, tissue is taken away
from the human body to help detect infection, diagnose a
medical condition, prevent disease.
Some examples of IVDs include systems to test the
1)level of coagulation,
2) urine test strips,
3)Home use pregnancy tests,
4)HIV or Hepatitis tests,
5)Blood glucose monitoring, etc.
9. Risk Based Classification In Accordance To CDSCO
CLASS RISK LEVEL IVD’s Examples
A Low Clinical Chemistry Analyzer, Prepared
selective culture media
B Low – Moderate Pregnancy self testing, Urine test strips
C Moderate – High Blood glucose self testing, Rubella
testing equipment
D High HIV blood donor screening, HIV Blood
test
10. USFDA
Class Risk level
Regulatory
requirements
Examples
I Low risk General controls
Stethoscopes
II Moderate risk
General controls ,
special controls
Syringe , MRI scanner
III High risk
General controls ,
PMA
Neuromuscular
stimulator
11. CLASS RISK LEVEL IVD’s Examples
A Low Individual Risk and
Low Public Health Risk
Clinical Chemistry Analyzers,
Specimen receptacles
B Moderate Individual Risk
and Low Public Health
Risk
Vitamin B12,Pregnancy Self Testing,
Urine test strips
C High Individual Risk and
Moderate Public Health
Risk
Blood Glucose Self Testing, PSA
Screening
D High Individual Risk and
High Public Health Risk
HIV Blood Diagnostic, HIV blood
donor
EU
12. Essential Principles of
Medical Devices and Ivd’s
The device when used for specified conditions, by experienced persons,
it should perform as intended without compromising the health and
safety of the patients.
Manufacturers should adopt solutions to identify and reduce risks as far
as possible during designing and manufacturing the devices.
The devices should perform as intended by the manufacturer and be
designed, manufactured and packaged in a manner to enable intended
use.
The above three characteristics should not deteriorate to such a point
during the shelf life of a medical device, as specified by the
manufacturer.
13. The devices should be designed, manufactured and packaged in a
manner that their performance or characteristics are not damaged
due to regular transport and storage conditions e.g. temperature
variation, humidity, etc.
Each medical device must have clinical evidence for intended use
and classification under the ‘Medical Devices Rules, 2017’,
demonstrating compliance with essential principles.
Manufacturers of IVD medical devices follow specified procedures
during design, manufacture and marketing.
14. S.No Medical Devices In-vitro Diagnostic devices
1 Definition Medical devices are
instruments apparatus,
appliance, material or
other article and
accessories to such
items as intended by
the manufacturer to be
used on human beings
for diagnosis,
prevention,
monitoring, treatment
or alleviation of
diseases.
IVD are medical devices and
accessories used In-vitro for
performing tests on samples such
as blood, urine, tissues taken
from the human body in order to
help detect infections, prevent
diseases, diagnose a medical
condition
2 Use In-vivo and ex-vivo use In- vitro use
Difference between Medical devices and Ivd’s
15. S.No Medical Devices In-Vitro Diagnostic
Devices
3 Active
Compone
nts
mechanical, electrical materials.
Many medical devices incorporate
and are driven by software.
Biological core
reagents
4 Purpose Diagnostic or therapeutic intended
use
Diagnostic intended
use
5 Examples Pacemakers, MRI machine, X-ray
machine, Ultrasound machines, Hip
implants, Sutures, tongue
depressors, bed pans, Blood glucose
meters.
Hepatitis tests, HIV
tests, Coagulation test
systems, Pregnancy
tests, Urine test strips,
Blood sugar
monitoring systems
for diabetes patients,
etc.
16. Combination Product
Combination products are defined in 21 CFR 3.2(e). The term combination
product includes:
A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/biologic, that
are physically, chemically, or otherwise combined or mixed and produced
as a single entity.
Two or more separate products packaged together in a single package or as
a unit and comprised of drug and device products, device and biological
products, or biological and drug products.
17. Classification of Combination Products
Combination products can be generally categorized into
separate classes based on their specific components:
Novel drug delivery systems.
Conventional drug delivery systems.
Drug-enhanced devices.
Regenerative medicinal products.
18. Novel drug delivery systems :
These products are designed to improve the convenience and comfort
of administration, and drug effectiveness through enable delivery of a
drug localized administration.
It refers to the approaches, formulations, technologies, and systems
for transporting a pharmaceutical compound in the body as needed to
safely achieve its desired therapeutic effects.
These products would be primarily ownered by the Center for Drug
Evaluation and Research (CDER) .
20. Conventional drug delivery systems :
▪ These products combine or package drugs together with injection devices to
improve convenience of administration.
▪ These components can also be regulated separately using the established
regulatory regimes for drugs and devices.
▪ Conventional routes for drug delivery are oral, buccal, rectal, subcutaneous,
intranasal, intramuscular, intravenous, pulmonary and transdermal.
Examples:
Pen-based delivery systems
Drug pumps
Profiled syringes
Auto injectors
21. Drug-enhanced devices: These products combine existing devices with
existing drugs enhance the functionality, performance, or efficacy of these
devices .
Examples:
• Drug-eluting stents(DES)
• Bone cements with antimicrobial agents
• Other devices with antimicrobial coatings
• Disinfective sutures
Drug-eluting stents(DES)
22. Regenerative medicinal products:
These products that combine devices with biologically
facilitate/enhance healing and active substances to regeneration of
damaged tissues.
The device often serves as the support structure for the growth of the
biologic component with the product often being an implant.
Examples:
Absorbable meshes for bone growth
Dermagraft (human fibroblast-derived dermal substitute)
Artificial replacement organs (such as the bio-artificial pancreas)
23. 1. Define and classify medical devices as per USFDA and CDSCO?
2. What is combination product and classify them with examples?
3. What are the essential principles of medical devices and Ivd’s?
24. REFERENCES
1. FDA medical devices - Search (bing.com)
2.FDA ivds - Search (bing.com)
3.medical devices classification - Bing images
4.Principles of In Vitro Diagnostic (IVD) Medical Devices
Classification | International Medical Device Regulators Forum
(imdrf.org)
5. Overview of IVD Regulation | FDA