“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.
Presentation: MMDR reform - Patient Implant Cards and Information LeafletsTGA Australia
The TGA has introduced a new regulatory requirement for manufacturers of implantable medical devices to provide patient implant cards and patient information leaflets with their devices. The implementation period starts from December 2018 for some devices and will apply to all implantable devices by December 2021. The TGA is engaging with health care systems to determine the best method of delivery of these resources to patients.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Last week ERS' Nisha Garg joined Schoolzilla, a data analytics company, to discuss how districts can use data strategically to find out if their resources align to their priorities. Garg shared two case studies where district leaders measured class size, instructional time, and student load per teacher to determine how to reallocate people, time, and money to better meet students’ needs.
“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.
Presentation: MMDR reform - Patient Implant Cards and Information LeafletsTGA Australia
The TGA has introduced a new regulatory requirement for manufacturers of implantable medical devices to provide patient implant cards and patient information leaflets with their devices. The implementation period starts from December 2018 for some devices and will apply to all implantable devices by December 2021. The TGA is engaging with health care systems to determine the best method of delivery of these resources to patients.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Last week ERS' Nisha Garg joined Schoolzilla, a data analytics company, to discuss how districts can use data strategically to find out if their resources align to their priorities. Garg shared two case studies where district leaders measured class size, instructional time, and student load per teacher to determine how to reallocate people, time, and money to better meet students’ needs.
Survei Persepsi Publik Terhadap Kemacetan di DKI JakartaRakyat Memilih
Survei jajak pendapat secara online ini bertujuan untuk mengetahui persepsi publik tentang masalah kemacetan di DKI Jakarta. Jajak pendapat dilakukan secara online dan diikuti oleh 440 responden. Periode survei Minggu pertama Maret 2017. Survei ini dibuat oleh Rame.id sebuah aplikasi jajak pendapat dan media analisis.
IOS: http://apple.co/2luaU03
Android : bit.ly/rameandroid
Medical Devices Law 2015 (Addition by DRAP)Bilal Mumtaz
The addition of the medical device law by the Drug Regulatory of Pakistan to register medical devices in Pakistan, as per national requirements (equivalence of FDA, CE, and ISO)
Presentation from the 3rd Joint Meeting of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Networks, organised by the European Centre of Disease Prevention and Control - Stockholm, 11-13 February 2015
We have successful terminologies for medicines but medical devices have much greater variety and are inherently harder to describe. We need international standards for device terminology and identification on both the clinical side and for the supply chain.
Health Datapalooza IV: June 3rd-4th, 2013
The State of the Art: Enterprise Data Use at the Point of Care
Moderator:
Janet Marchibroda, Director, Health Innovation Initiative, Bipartisan Policy Center
The new delivery models have made it clear- they need health information technology (IT) and data in order to succeed in providing high value health care. Many decision-makers and clinical staff are overwhelmed by or are looking for the evidence to support using the increasing amount and divergent types of data that can be leveraged at the enterprise level and point of care. Patient-generated data, open data streams, cost and quality information – how will it fit into the clinical workflow, and does it make a difference in operations and clinical outcomes? Join us for demos and a discussion of the state of the art.
Panel A (3:30-4:15pm): Enterprise-Level Data Analytics
Speakers:
Jack Challis, Chief Executive Officer & Co-Founder, CliniCast
Allen Kamer, Vice President Corporate Development and Marketing, Humedica
Jonathan Porter, Vice President Product Strategy, athenahealth
Eric Page, Chief Executive Officer, Amplify Health
Graham Gardner, Chief Executive Officer, Kyru.us
Panel B (4:15-5:00 pm): Data at the Point of Care
Speakers:
Jason Bhan, Executive Vice President & Co-founder, Medivo
Madhu Nutakki, Vice President of Digital Presence Technologies, Kaiser Permanente
Noah Craft, Chief Medical Officer, VisualDx
Michael Long, Chief Executive Officer, Lumeris
Omri Gottesman, CLIPMERGE, Mount Sinai School of Medicine
These sessions are eligible for continuing education credit.
Similar to دليل المستهلكات و المستلزمات الطبية (20)
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.
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.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
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.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
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.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
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.
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.
1. واﻟﻣﺳﺗﻠزﻣﺎت ﻟﻠﻣﺳﺗﮭﻠﻛﺎت واﻟﺗرﻣﯾز اﻟﺗﺻﻧﯾف دﻟﯾل
اﻟطﺑﯾﺔ/اﻟﺻﺣﺔ وزارة
Classification and Coding Manual for Disposables
Consumables and Medical Supplies
Ministry of Health
ﻋﻣﺎن/اﻻردن
٢٠١٤
واﻟﻣﺳﺗﻠزﻣﺎت ﻟﻠﻣﺳﺗﮭﻠﻛﺎت واﻟﺗرﻣﯾز اﻟﺗﺻﻧﯾف دﻟﯾل
اﻟطﺑﯾﺔ/اﻟﺻﺣﺔ وزارة
Classification and Coding Manual for Disposables
Consumables and Medical Supplies
Ministry of Health
ﻋﻣﺎن/اﻻردن
٢٠١٤
واﻟﻣﺳﺗﻠزﻣﺎت ﻟﻠﻣﺳﺗﮭﻠﻛﺎت واﻟﺗرﻣﯾز اﻟﺗﺻﻧﯾف دﻟﯾل
اﻟطﺑﯾﺔ/اﻟﺻﺣﺔ وزارة
Classification and Coding Manual for Disposables
Consumables and Medical Supplies
Ministry of Health
ﻋﻣﺎن/اﻻردن
٢٠١٤
22. ٢٢
(90)واﻵﻻت اﻟﺣﺎﺳوب أﺟﮭزةاﻟﻣﻛﺗﺑﯾﺔواﻟﻣﻘﺎﺳم
90-01 : Computer Equipment and Accessories
90-02 : Data Voice or Multimedia Network Equipment or Platforms and
Accessories
90-03 : Datacom and network connectivity installation devices and equipment
90-04 : Communications Devices and Accessories
90-05 : Components for information technology or broadcasting or
telecommunications