http://MedicalDevicesGroup.net Sydney-based regulatory affairs expert Arthur Brandwood discusses the recent changes made by the Australian Therapeutic Goods Administration (TGA).
He also covers:
• Australia’s aggressive deregulatory agenda
• The Australian tax incentive (43.5% for R&D expenditure)
• The simple process for regulation of clinical trials in Australia
• TGA’s web based submission process for device approvals
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
The regulation of medical devices in AustraliaTGA Australia
View this presentation for information on:
* what are medical devices, and how they compare to medicines in terms of regulation
* the process for a device to get to market and how they are classified according to risk
* the essential principles and conformity assessment
* safety and performance of devices.
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
Device Sponsor Information Day: Session 4B: Medical Devices (IVDs) - applicat...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic 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
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
Medical device management in china and latest regulatory updates_EdwinCIRS China
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
Medical device classification following MDR 2017/745Monir EL AZZOUZI
MDR 2017/745 Medical Device Classification. What are the regulatory changes for the new Medical Device Regulation. What is new on the classification of the products. Annex VIII contains 22 rules with 4 new rules. Receive a free form to download and some infographic. This slidedeck is provided by Easy Medical Device. #medtech #medicaldevice #medicaldevices
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
Device Sponsor Information Day: Session 4B: Medical Devices (IVDs) - applicat...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic 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
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
Medical device management in china and latest regulatory updates_EdwinCIRS China
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Devices Sponsor Information Day: 0 - Developments in medical device regulationTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
Presentation given at SMI's Biosimilar and Biobetter Conference 2015 in London. The presentation discusses challenges and opportunities for developers of biosimilar products and how medical device components can provide a competitive advantage.
AzCI presents: Medical Device Regulations through the FDAAnitaBell
Arizona Center for Innovation (AzCI) presents: Working with Your Demographic Market (in orphan drug development)
This presentation is part of a series developed for a workshop on "How to Navigate the Biotech Regulatory Process"
The Arizona Center for Innovation is an incubator and innovation center and provides resources in support of startups getting to the next level and become successful enterprises.
How to survive the Perfect Storm – International Harmonization and Lessons fr...brandwoodbiomedicalcom
This month we look at global regulatory strategy in times of uncertainty. Remember just yesterday when CE was a smooth and quick process and CE mark gave a passport to so many other markets. Suddenly everything changed. We look at what the implications of changes in Europe (MDR Brexit), the US (New 5410k pathways, SaMD) and other markets such as Australia (leveraging Canada, Japan as well as US and CE) and of course, MDSAP. And amongst all of this we have to keep in sight the commercial and marketing objectives. Join Arthur Brandwood and Grant Bennett who ask: “how do I build a global regulatory strategy that is fit for today, and for whatever tomorrow may bring?”
Presented by: Arthur Brandwood and Grant Bennett, Brandwood Biomedical
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
PECB Webinar: Proposed changes for medical device quality management systems ...PECB
We will cover:
• Overview of proposed changes to ISO 13485:201X, MDSAP
• New EU regulations and unannounced audits
• New directions for QMS and regulatory audits
Presenter:
This webinar will be presented by Danny Kroo, the founder and principal consultant at Docusys Corporation.
Devices Sponsor Information Day: 1 - Conformity AssessmentTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
How to get your COVID-19 Related Medical Device to Market Under FDA Emergency...Greenlight Guru
What quality and regulatory steps are needed to get your COVID-19 related device on the market under FDA Emergency Use Authorization. The FDA has been very active in publishing new guidances and updates for COVID-19 related devices that are in high demand. RookQS has worked with many manufacturers and distributors around the world to address the COVID-19 related shortages on devices, diagnostics, and PPE.
• Overview of the requirements for the COVID related devices and supplies under high demand during the current COVID pandemic
• Overview on diagnostic and at home testing kits
• Overview on hand sanitizer registration and testing for manufacturers and distributors
• Overview on respirator regulations and testing for manufacturers and distributors
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
http://MedicalDeviceEvents.com At the 10x Medical Device Conference in 2014, presenters Carrie Kuehn, Jorge Ochoa, and Robert Packard explained why, according to data from FDA, more than 58% of 510(k) submissions were refused under FDA’s Refuse to Accept (RTA) policy during its first year of implementation.
This presentation examined some of the reasons why industry got such a bad “grade.” We discussed the RTA requirements and some of the challenges from industry’s perspective on meeting the requirements of the RTA checklist and ended with recommendations on how industry can improve its odds of getting past the RTA hurdle on the first try.
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
How Medical Device Sites are Evolving 2015Joe Hage
http://medgroup.biz/device-sites for the accompanying video.
Joe Hage, leader of the Medical Devices Group, reviews how 33 life science company websites evolved over the past two years.
The presentation contains before-and-after screen captures of 33 life science company websites along with recommended references and free online tools to use in your website development and user interface testing.
WHO WILL VALUE THE PRESENTATION:
• Marketers at every level in the organization
• Business Development Executives
• VPs and Directors of Sales
• Regional Sales Managers
• Inside Sales Managers
• Medical Device Distributors
CEO of Infinitum Humanitarian Systems Eric Rasmussen, MD, MDM, FACP helped the Medical Devices Group understand the depth of the challenges to global health.
You really have to watch his talk (some of the images will take your breath away) for the full impact of the presentation and please share it on social media and with your colleagues.
Visit http://medgroup.biz/future-global-health for the video recap and transcript and consider the 10x Medical Device Conference to meet speakers like Eric.
For 10x information, see http://medgroup.biz/About-10x
Selling Medical Devices in this Difficult Healthcare EnvironmentJoe Hage
http://medgroup.biz/meddevsales Medical Devices Group member Mike Sperduti shares the medical device selling strategies he effectively uses for GE Healthcare, Becton Dickinson, and his other medical device clients.
Mike, himself a medical device manufacturer, covers winning strategies for product launches, implementing contracts, and turning around under-performing territories.
Very well received on the live presentation. You're welcome to listen to the replay at http://medgroup.biz/meddevsales.
Global unique device identification database (gudid) and udiJoe Hage
Medical device companies are affected by the Unique Device Identification ruling from FDA. UDI experts Reed Tech help members of the Medical Devices Group understand the complexities.
You can find the audio replay and transcript at http://medgroup.biz/unique-device-identification
Roadmap to sustainable innovation for medical device manufacturersJoe Hage
How nearly 100 Medical Device Manufacturers assessed their current innovation management capabilities and how they can improve productivity, time-to-market, and commercial success.
Unique Device Identification UDI Requirements and Timelines Joe Hage
http://MedicalDevicesGroup.net Reed Technology, in collaboration with the Medical Devices Group, present information regarding the FDA's Unique Device Identifier (UDI) and discuss strategies to implement your UDI submissions solution.
An overview of the U.S. healthcare industry hiring outlook for device, medtech, and diagnostic companies grappling with increased regulation, the 2.3% device tax, ACA provisions, and a candidate-driven market.
Contemporary Medical Device Marketing for the Digital AgeJoe Hage
Medical Device Marketing can be far more robust than many in the medical device industry presently practice. For the video replay and transcript which accompany these slides, see http://MedicalDevicesGroup.net/webinar/medical-device-marketing/
FDA Audit Process Training using turtle diagrams presented by Rob Packard, founder of http://MedicalDeviceAcademy.com and Brigid Glass, CEO of Brigid Glass & Associates.
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdf
TGA changes for Medical Devices in Australia
1. BRANDWOOD
BIOMEDICAL
securing your compliance
www.brandwoodbiomedical.com
The Big Changes in Australia in Medical Devices Product Development and Market Access Down Under
Dr Arthur Brandwood
•Previous Director Devices Registration and Assessment at TGA and Director, TGA Biomaterials and Engineering Laboratories
•Past National Chair and Chair Regulatory Expert Panel AusMedtech
•Member of AHWP SG1 and Leader of Combination Products Task group
•Adviser and trainer to multiple Asia Pacific regional regulators
•Australian Delegation Leader to ISO TC 194 – Biocompatibility and Clinical Trials and ISO TC 150 – Implantable Devices
•Past President Australian Society for Biomaterials
•Visiting Professor in Biomedical Engineering, University of Sydney
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BRANDWOOD:BIOMEDICAL securing your compliance
Medical Devices and IVDs
Asia Pacific Focus
Global Perspective
Highly Networked
Highly Engaged
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The Single Largest Manufacturing Sector Exporting from Australia to China is Therapeutics (Medical Devices and Pharmaceuticals)
Australian Bureau of Statistics
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Limited Resources: <100 in Devices
Acts as both Competent Authority and Conformity Assessment Body
Strong scientific culture – this was once a laboratory building!
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Therapeutic Goods Act 1989 http://www.tga.gov.au/industry/legislation.htm
Chapter 1—Preliminary
Chapter 2—Australian Register of Therapeutic Goods
Chapter 3—Medicines and other therapeutic goods that are not medical devices
Part 3-1—Standards
Part 3-2—Registration and listing of therapeutic goods
Part 3-3—Manufacturing of therapeutic goods
Chapter 4—Medical devices
Part 4-1—Introduction
Part 4-2—Essential principles and medical device standards
Part 4-3—Conformity assessment procedures
Part 4-4—Conformity assessment certificates
Part 4-5—Including medical devices in the Register
Part 4-6—Suspension and cancellation from the Register
Part 4-7—Exempting medical devices from inclusion in the Register
Part 4-8—Obtaining information
Part 4-9—Public notification and recovery of medical devices
Part 4-10—Assessment fees
Part 4-11—Offences and civil penalty provisions relating to medical devices
Chapter 5—Advertising, counterfeit therapeutic goods and product tampering
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Therapeutic Goods (Medical Devices) Regulations 2002 Includes AIMDs and IVDs
5.7 Active implantable medical devices (1) An active implantable medical device is classified as Class AIMD.
Four New Rules for IVDs
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Special Access
Clinical Trials
Authorised Prescriber
Custom Made
CTN
CTX
SAS B
SAS A
ARTG Inclusion
Exempt Goods
Personal Imports
AIMD Act Implant
III
IIb
I
NO TGA assessment of safety
MUST MEET safety and performance requirements
Generally humanitarian exemptions or advance access to new technology pending completion of TGA regulatory assessment
For Investigational use only – for research or to gather clinical data to support subsequent TGA assessment
This is a unique Australian regulatory peculiarity – a person may import any device or medicine (except S8 poisons e.g. narcotics) for personal use at own risk
These are single devices individually manufactured to clinical prescription for a named patient (e.g. dental crowns, orthotic braces)
These are very low risk goods (e.g. hospital bedding, protective clothing, conventional toothpastes)
These devices and IVDs are subject to TGA regulatory assessment which increases with higher numbered risk class
These devices are NOT assessed by TGA and are EXEMPT from inclusion on ARTG – but they must still meet safety and performance regulations and are subject to postmarket monitoring
IIa
IVD 4
IVD 3
IVD 2
IVD 1
Australian Regulatory Requirements
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Sponsor – the Australian Authorized Representative
Must be Australian company
May be third party
Provides manufacturer info to TGA on demand
•Contractual arrangement with manufacturer
BRANDWOOD BIOMEDICAL securing your compliance
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TGA accepts CE certificates in lieu of Australian Certificates for most devices
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Manufacturer Sponsor TGA
Determine
AU Class
Technical
File Data
Australian
D.o.C
CE
Certification
Accepted
Manufacturer
Evidence
Sponsor
Makes ARTG
Application for
Device
Sponsor
Submits To TGA
e Assess
e Assess ARTG Entry
Application
Audit
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Exclusions to the CE Fast Track
Class III with integral medicine
•Also requires TGA medicine assessment
Class III with biological component
•Includes recombinant products, blood products
•Some low risk exceptions e.g. gelatine
All Australian manufactured devices
•Direct TGA assessment is mandatory for the locals
•TGA may abridge assessment if device is CE marked
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“As an important first step, the Government will enable Australian manufacturers of medical devices the option of using European Union certification in place of TGA certification. This will place Australian manufacturers on the same footing as overseas competitors.”
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Exclusions to the CE Fast Track
Class III with integral medicine
•Also requires TGA medicine assessment
Class III with biological component
•Includes recombinant products, blood products
•Some low risk exceptions e.g. gelatine
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Multiple Reviews of TGA
3 Senate enquiries
Auditor General Review
HTA Review
…
TGA
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It’s all about Confidence…
TGA is undertaking Confidence Building with EC Notified Bodies
−Shared Audits
−Document reviews
−Information Exchange
Reduced Application audits for those in which TGA has Confidence
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Special Access
Clinical Trials
Authorised Prescriber
Custom Made
CTN
CTX
SAS B
SAS A
ARTG Inclusion
Exempt Goods
Personal Imports
AIMD Act Implant
III
IIb
I
NO TGA assessment of safety
MUST MEET safety and performance requirements
Generally humanitarian exemptions or advance access to new technology pending completion of TGA regulatory assessment
For Investigational use only – for research or to gather clinical data to support subsequent TGA assessment
This is a unique Australian regulatory peculiarity – a person may import any device or medicine (except S8 poisons e.g. narcotics) for personal use at own risk
These are single devices individually manufactured to clinical prescription for a named patient (e.g. dental crowns, orthotic braces)
These are very low risk goods (e.g. hospital bedding, protective clothing, conventional toothpastes)
These devices and IVDs are subject to TGA regulatory assessment which increases with higher numbered risk class
These devices are NOT assessed by TGA and are EXEMPT from inclusion on ARTG – but they must still meet safety and performance regulations and are subject to postmarket monitoring
IIa
IVD 4
IVD 3
IVD 2
IVD 1
Australian Regulatory Requirements
Clinical Trial Notification
•Ethics Committee assessment of the protocol and oversight of trial
•TGA may audit the trial
•Nominal Fees
•Notification only to TGA
•All devices have been done this way to date
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National Controls
http://www.australianclinicaltrials.gov.au/node/30
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“…it's CASH, paid quarterly, not a tax credit”
“Note the difference between the rebate and the tax rate - effectively the rebate is a subsidy way higher than the tax deductibility of these expenses”
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Free Money – from the Tax Man The Australian R&D Tax Incentive
45% Refundable Offset
−Non refundable for firms >$20M turnover
−For small firms – paid as refund, quarterly
Eligible Entities
−Australian companies
−Foreign companies in countries with double tax agreement which have permanent establishment in Australia
https://www.ato.gov.au/Business/Research-and-development-tax-incentive/
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The R&D challenge…
Clinical Challenge
•Bowel Preps available in Australia not effective
•Require significant investment to develop data
•High patient population requires significant sample size
Clinical Trial Required
•Multicentre
•Randomised
•CRA Audited
•300 Patients
•$ 1 Million budget
ANZ operations didn’t have budget to support
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R&D Tax Incentive
Given ANZ subsidiary, local profits 3-4%
Provided potential for legitimate cost savings and capability
Needed to demonstrate that proposed trial outcomes had not already been demonstrated ie: True R&D
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Employee Share Options
July 2015 commencement
Defer tax until exercise of options
Maximum time for deferral 15 years
Standardised documentation for establishment and maintenance of ESS.
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Start-up Concession for ESS Unlisted Co. / Aggregate Turnover <$50M / Inc. < 10 Years
Tax exempt first $1,000 for employees earning <$180,000
Shares at discount of up to 15% with no tax liability for discount
−Discounted portion is exempt from CGT at time of sale
Shares must be held at least 3 years
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Why Australia?
Deregulation
Clinical Trials
R&D Tax Concessions
Employee Options Tax Concessions
Trade with Asia
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Regulatory Trends in Asia Pacific
2015
ASEAN MDD Commences
2014
ASEAN harmonizes IVD registration format
New Provisions in China
Japan PMDL
Malaysia Regulations
2013
China SFDA becomes CFDA
2011
India Medical Devices
2010
HK Medical Devices Registrations
2009
Korea High-risk IVD Tougher regs
2008
HK IVD Voluntary Product Listing
Singapore Mandatory Registration
2007
Major Regulation Change in China
2006
Malaysia Voluntary Product Listing
2005
Japan PAL
2004
Hong Kong Medical Device Registration –excludes IVDs
Singapore Voluntary Listing
2002
China Mandatory Product Registration
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Let’s talk!
TGA Submissions
Australian Sponsor Service
−and others including China
Regulatory Strategy
Risk Analysis and Standards Compliance
Quality Systems
Clinical Trials
Postmarket Compliance
Reimbursement
Regulatory Intelligence
Training
Contact us for a free no- obligation consultation and quote
+61 2 9906 2984
help@brandwoodbiomedical.com
www.brandwoodbiomedical.com
Brandwood Biomedical has offices in Sydney, Wellington and Beijing and offers specialist expertise throughout the Asia Pacific