E-newsletter focusing on regulatory issues of medical devices with links to the sources of information
“International Medical Devices Regulatory NEWS-IN-BRIEF” is published monthly (11 issues per year)
LEGIPHARM International publishes also in French “Info Dispositifs Médicaux” and the “Brèves d’Actualités”
eHealth Tools & Services: Needs of the Member States Report of the WHO Global...Dr Lendy Spires
The document summarizes the findings of the first global survey conducted by the WHO Global Observatory for eHealth (GOe) regarding the needs of WHO Member States for eHealth tools and services. Key findings include that Member States would welcome WHO's involvement in developing generic eHealth tools and guidance for creating and implementing eHealth services. Non-OECD countries expressed a need for guidance across a broad range of eHealth areas. The report recommends actions WHO could take to address Member States' needs, such as facilitating the development of commonly requested tools, providing access to existing tools and services, and supporting knowledge exchange and eHealth information resources.
This document outlines the agenda for a workshop on managing app development under FDA regulation. The agenda includes:
- An introduction and welcome session
- A presentation on EU regulatory updates and strategies for global regulatory compliance, covering recent EU developments around software medical devices, accessories, wellness apps, and data protection
- A panel discussion featuring a case study on regulatory leadership and business strategies for bringing new apps to market
- A session analyzing the new FDA guidance on the scope of FDA regulation
- Audience case studies and a question and answer period
Presentation at the 29-30 January 2014 Informa Medical Devices Revision conference in Brussels regarding developments in relation to the Eudamed database and its rule in the new EU medical devices system
OBJECTIVES OF SITE INVESTIGATION BASED ON BS 5930 (1981) 5006
The document outlines the objectives of site investigations based on BS 5930 (1981) for civil engineering projects. The main objectives are to determine site suitability, enable adequate and economic design, plan the best construction method, determine how the site may change over time, and provide guidance when multiple site options exist. Additional objectives are to report on site conditions, design additional works, and investigate cases of past failures.
This document summarizes recent EU developments related to mHealth. It discusses:
1) The proposed new definition of "medical device" under EU regulations that would expand the scope and impact mobile health apps.
2) Accessories are increasingly being regulated as medical devices themselves, even if they are not medical devices.
3) There is no clear EU position yet on regulating health and wellness apps versus medical apps. A Green Paper from the European Commission is expected.
4) Enforcement of medical device regulations for software is increasing and being interpreted differently across EU member states.
Site-investigation before construction of structure.Pirpasha Ujede
This document discusses stress intensity and depth of exploration for friction piles. It examines the depth of exploration needed for friction piles and the lateral extent of explorations required.
THE STUDY OF EFFECTIVENESS OF MUNICIPAL SOLID WASTE MANAGEMENT SYSTEM AT RESI...Firdaurs Abdullah
THIS IS MY BDP TECHNICAL REPORT SUBMITTED FOR ORAL EXAMINATION IN PARTIAL FULLFILLMENT OF THE REQUIREMENT FOR THE AWARD OF THE DEGREE OF BACHELOR OF CIVIL ENGINEERING
eHealth Tools & Services: Needs of the Member States Report of the WHO Global...Dr Lendy Spires
The document summarizes the findings of the first global survey conducted by the WHO Global Observatory for eHealth (GOe) regarding the needs of WHO Member States for eHealth tools and services. Key findings include that Member States would welcome WHO's involvement in developing generic eHealth tools and guidance for creating and implementing eHealth services. Non-OECD countries expressed a need for guidance across a broad range of eHealth areas. The report recommends actions WHO could take to address Member States' needs, such as facilitating the development of commonly requested tools, providing access to existing tools and services, and supporting knowledge exchange and eHealth information resources.
This document outlines the agenda for a workshop on managing app development under FDA regulation. The agenda includes:
- An introduction and welcome session
- A presentation on EU regulatory updates and strategies for global regulatory compliance, covering recent EU developments around software medical devices, accessories, wellness apps, and data protection
- A panel discussion featuring a case study on regulatory leadership and business strategies for bringing new apps to market
- A session analyzing the new FDA guidance on the scope of FDA regulation
- Audience case studies and a question and answer period
Presentation at the 29-30 January 2014 Informa Medical Devices Revision conference in Brussels regarding developments in relation to the Eudamed database and its rule in the new EU medical devices system
OBJECTIVES OF SITE INVESTIGATION BASED ON BS 5930 (1981) 5006
The document outlines the objectives of site investigations based on BS 5930 (1981) for civil engineering projects. The main objectives are to determine site suitability, enable adequate and economic design, plan the best construction method, determine how the site may change over time, and provide guidance when multiple site options exist. Additional objectives are to report on site conditions, design additional works, and investigate cases of past failures.
This document summarizes recent EU developments related to mHealth. It discusses:
1) The proposed new definition of "medical device" under EU regulations that would expand the scope and impact mobile health apps.
2) Accessories are increasingly being regulated as medical devices themselves, even if they are not medical devices.
3) There is no clear EU position yet on regulating health and wellness apps versus medical apps. A Green Paper from the European Commission is expected.
4) Enforcement of medical device regulations for software is increasing and being interpreted differently across EU member states.
Site-investigation before construction of structure.Pirpasha Ujede
This document discusses stress intensity and depth of exploration for friction piles. It examines the depth of exploration needed for friction piles and the lateral extent of explorations required.
THE STUDY OF EFFECTIVENESS OF MUNICIPAL SOLID WASTE MANAGEMENT SYSTEM AT RESI...Firdaurs Abdullah
THIS IS MY BDP TECHNICAL REPORT SUBMITTED FOR ORAL EXAMINATION IN PARTIAL FULLFILLMENT OF THE REQUIREMENT FOR THE AWARD OF THE DEGREE OF BACHELOR OF CIVIL ENGINEERING
Update on software as a medical device (SaMD)TGA Australia
This presentation will explore the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software will be discussed in relation to their likely classification as a medical device.
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.
The regulatory framework for medical devices in India is based on drug regulations under the Drugs and Cosmetics Act of 1940 and Drugs and Cosmetics Rules of 1945. The Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO) regulates medical devices and IVDs. Currently only a limited number of medical device and IVD products require registration in India, including ablation devices, dental implants, and hernia mesh. The registration process for notified devices can take 9-12 months and involves appointing an authorized agent, compiling an application, and obtaining CDSCO approval.
This document discusses subsoil exploration, which involves collecting soil data through field and laboratory investigations to assess soil properties at a site. The main objectives are to determine the nature, depth, thickness, and extent of soil strata, as well as groundwater depth and properties. Exploration methods include direct techniques like test pits and borings, and indirect techniques like sounding tests and geophysical methods. Standard penetration tests are commonly used to determine properties of cohesionless soils by counting blows required to penetrate the soil. Corrections are applied to penetration values to account for overburden pressure and sample dilatancy.
1. A site investigation determines the suitability of a site for construction by examining physical aspects like soil composition and legal aspects like planning permissions.
2. The investigation assesses the site suitability, helps with design and construction planning, and predicts potential issues. Information is needed on soil properties, groundwater, and excavated materials.
3. The investigation process involves a desk study of existing information, a site walkover, detailed tests and sampling which may include trial pits and boreholes to examine soil and groundwater conditions.
The document summarizes the stages of a site investigation which includes a desk study, site reconnaissance, detailed exploration and sampling, field/in-situ testing, and laboratory testing. The objectives are to assess suitability, enable adequate design, plan construction, determine ground changes, and document the investigation in a report. Site investigations involve exploring ground conditions through methods like boreholes, trial pits, and geophysical surveys to inform engineering design decisions.
Site investigation involves determining the soil layers and properties beneath a proposed structure. It helps select the foundation type and depth, evaluate load capacity, estimate settlement, and identify potential issues. The exploration program uses methods like test pits, auger and wash borings, probing, and geophysics to obtain samples and measure properties. A site investigation includes planning borings and tests, executing fieldwork, and reporting the findings and recommendations.
The document discusses soil investigation methods used to characterize soil properties for engineering projects. It describes different soil horizons defined by composition and depth. Key soil characteristics discussed include color, texture, aggregation, porosity, ion content, and pH. Common soil investigation techniques are also summarized, such as trial pitting, dynamic probe testing, cable percussive boreholes, and rotary drilled boreholes. The purposes of soil investigations are to determine suitability for construction and adequate foundation design while anticipating difficulties.
This document provides an introduction to pharmacovigilance. It defines pharmacovigilance as the science relating to detecting, assessing, understanding, and preventing adverse drug reactions. The document outlines the need for pharmacovigilance due to limitations of clinical trials, medication errors, and adverse drug reactions being a leading cause of death. It describes Egypt's pharmacovigilance center and important terms like adverse drug reactions, adverse events, and serious reports. Healthcare professionals, patients, and marketing authorization holders should report valid adverse events containing identifiable information to the pharmacovigilance center.
This document provides an introduction to pharmacovigilance, which is the study of the safety of marketed drugs. It discusses the importance of pharmacovigilance due to past drug safety issues like the thalidomide tragedy. Key terms related to pharmacovigilance are defined, such as adverse events, adverse reactions, and signals. Methods of pharmacovigilance like passive surveillance, data mining, and active surveillance are described. Important organizations involved in pharmacovigilance include the FDA, EMEA, MHLW, and CDSCO.
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
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to improve patient safety by understanding drug risks. Clinical trials cannot detect all risks due to limited size and duration. Spontaneous reporting allows healthcare providers to report suspected adverse drug reactions. Limitations of clinical data and withdrawals like thalidomide led to pharmacovigilance programs worldwide including the WHO program and national programs in India, UK, and US. Pharmacovigilance involves collecting, analyzing, and communicating safety information to improve patient therapy and public health.
EU regulatory frameworks - Legal challenges and opportunities for digital hea...DayOne
Presentation by Karin Schulze, Head of Medical Devices at SFL at the DayOne Expert Event Legal challenges and opportunities for digital health innovation
Regulation
Regarding the new MDR, the big question that arises is not only whether a piece of software falls under the definition of a medical device, but also who decides whether it does. At least in this regard the new regulation is clear: it is the regulator. Which means, according to Karin Shulze from SFL, that If a company offers an app which they do not consider a medical device themselves, but the regulator does, the distribution of this app will be stopped.
The global vital signs monitoring devices market size reached US$ 5.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 9.5 Billion by 2032, exhibiting a growth rate (CAGR) of 5.6% during 2024-2032.
More Info:- https://www.imarcgroup.com/vital-signs-monitoring-devices-market
Tele Intensive Care Unit Market PPT: Growth, Outlook, Demand, Keyplayer Analy...IMARC Group
The global tele intensive care unit market size reached US$ 5.8 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 18.0 Billion by 2032, exhibiting a CAGR of 13.1% during 2024-2032.
More Info:- https://www.imarcgroup.com/tele-intensive-care-unit-market
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...TGA Australia
The document summarizes the results of a consultation on proposed reforms to the regulation of software as a medical device in Australia. It discusses key points from international approaches to classifying and regulating software, proposed new classification rules and essential principles for software in Australia, and the results of the consultation which found general agreement with the proposals among respondents.
Durable Medical Equipment (DME) Market PPT: Growth, Outlook, Demand, Keyplaye...IMARC Group
The global durable medical equipment (DME) market size reached US$ 204.2 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 294.4 Billion by 2028, exhibiting a growth rate (CAGR) of 6.2% during 2023-2028.
More Info:- https://www.imarcgroup.com/durable-medical-equipment-market
The document proposes an Android-based mobile application called the E-Nursing System. The application allows registered users to call the nearest ambulance by pressing a help button on their phone. It will also notify the user's favorite emergency contacts and the closest hospital. When help is requested, the app uses the user's location data from GPS to notify the nearest ambulance. It also sends an alert message to the hospital to prepare for arrival. The proposed system aims to provide fast emergency assistance to users by streamlining communication between patients, ambulances, and hospitals.
Aerosol Delivery Devices Market by Product Type, Distribution Channel, End Us...IMARC Group
The global aerosol delivery devices market size reached US$ 44.4 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 63.3 Billion by 2028, exhibiting a growth rate (CAGR) of 5.4% during 2023-2028.
More Info:- https://www.imarcgroup.com/aerosol-delivery-devices-market
Update on software as a medical device (SaMD)TGA Australia
This presentation will explore the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software will be discussed in relation to their likely classification as a medical device.
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.
The regulatory framework for medical devices in India is based on drug regulations under the Drugs and Cosmetics Act of 1940 and Drugs and Cosmetics Rules of 1945. The Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO) regulates medical devices and IVDs. Currently only a limited number of medical device and IVD products require registration in India, including ablation devices, dental implants, and hernia mesh. The registration process for notified devices can take 9-12 months and involves appointing an authorized agent, compiling an application, and obtaining CDSCO approval.
This document discusses subsoil exploration, which involves collecting soil data through field and laboratory investigations to assess soil properties at a site. The main objectives are to determine the nature, depth, thickness, and extent of soil strata, as well as groundwater depth and properties. Exploration methods include direct techniques like test pits and borings, and indirect techniques like sounding tests and geophysical methods. Standard penetration tests are commonly used to determine properties of cohesionless soils by counting blows required to penetrate the soil. Corrections are applied to penetration values to account for overburden pressure and sample dilatancy.
1. A site investigation determines the suitability of a site for construction by examining physical aspects like soil composition and legal aspects like planning permissions.
2. The investigation assesses the site suitability, helps with design and construction planning, and predicts potential issues. Information is needed on soil properties, groundwater, and excavated materials.
3. The investigation process involves a desk study of existing information, a site walkover, detailed tests and sampling which may include trial pits and boreholes to examine soil and groundwater conditions.
The document summarizes the stages of a site investigation which includes a desk study, site reconnaissance, detailed exploration and sampling, field/in-situ testing, and laboratory testing. The objectives are to assess suitability, enable adequate design, plan construction, determine ground changes, and document the investigation in a report. Site investigations involve exploring ground conditions through methods like boreholes, trial pits, and geophysical surveys to inform engineering design decisions.
Site investigation involves determining the soil layers and properties beneath a proposed structure. It helps select the foundation type and depth, evaluate load capacity, estimate settlement, and identify potential issues. The exploration program uses methods like test pits, auger and wash borings, probing, and geophysics to obtain samples and measure properties. A site investigation includes planning borings and tests, executing fieldwork, and reporting the findings and recommendations.
The document discusses soil investigation methods used to characterize soil properties for engineering projects. It describes different soil horizons defined by composition and depth. Key soil characteristics discussed include color, texture, aggregation, porosity, ion content, and pH. Common soil investigation techniques are also summarized, such as trial pitting, dynamic probe testing, cable percussive boreholes, and rotary drilled boreholes. The purposes of soil investigations are to determine suitability for construction and adequate foundation design while anticipating difficulties.
This document provides an introduction to pharmacovigilance. It defines pharmacovigilance as the science relating to detecting, assessing, understanding, and preventing adverse drug reactions. The document outlines the need for pharmacovigilance due to limitations of clinical trials, medication errors, and adverse drug reactions being a leading cause of death. It describes Egypt's pharmacovigilance center and important terms like adverse drug reactions, adverse events, and serious reports. Healthcare professionals, patients, and marketing authorization holders should report valid adverse events containing identifiable information to the pharmacovigilance center.
This document provides an introduction to pharmacovigilance, which is the study of the safety of marketed drugs. It discusses the importance of pharmacovigilance due to past drug safety issues like the thalidomide tragedy. Key terms related to pharmacovigilance are defined, such as adverse events, adverse reactions, and signals. Methods of pharmacovigilance like passive surveillance, data mining, and active surveillance are described. Important organizations involved in pharmacovigilance include the FDA, EMEA, MHLW, and CDSCO.
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
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to improve patient safety by understanding drug risks. Clinical trials cannot detect all risks due to limited size and duration. Spontaneous reporting allows healthcare providers to report suspected adverse drug reactions. Limitations of clinical data and withdrawals like thalidomide led to pharmacovigilance programs worldwide including the WHO program and national programs in India, UK, and US. Pharmacovigilance involves collecting, analyzing, and communicating safety information to improve patient therapy and public health.
EU regulatory frameworks - Legal challenges and opportunities for digital hea...DayOne
Presentation by Karin Schulze, Head of Medical Devices at SFL at the DayOne Expert Event Legal challenges and opportunities for digital health innovation
Regulation
Regarding the new MDR, the big question that arises is not only whether a piece of software falls under the definition of a medical device, but also who decides whether it does. At least in this regard the new regulation is clear: it is the regulator. Which means, according to Karin Shulze from SFL, that If a company offers an app which they do not consider a medical device themselves, but the regulator does, the distribution of this app will be stopped.
The global vital signs monitoring devices market size reached US$ 5.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 9.5 Billion by 2032, exhibiting a growth rate (CAGR) of 5.6% during 2024-2032.
More Info:- https://www.imarcgroup.com/vital-signs-monitoring-devices-market
Tele Intensive Care Unit Market PPT: Growth, Outlook, Demand, Keyplayer Analy...IMARC Group
The global tele intensive care unit market size reached US$ 5.8 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 18.0 Billion by 2032, exhibiting a CAGR of 13.1% during 2024-2032.
More Info:- https://www.imarcgroup.com/tele-intensive-care-unit-market
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...TGA Australia
The document summarizes the results of a consultation on proposed reforms to the regulation of software as a medical device in Australia. It discusses key points from international approaches to classifying and regulating software, proposed new classification rules and essential principles for software in Australia, and the results of the consultation which found general agreement with the proposals among respondents.
Durable Medical Equipment (DME) Market PPT: Growth, Outlook, Demand, Keyplaye...IMARC Group
The global durable medical equipment (DME) market size reached US$ 204.2 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 294.4 Billion by 2028, exhibiting a growth rate (CAGR) of 6.2% during 2023-2028.
More Info:- https://www.imarcgroup.com/durable-medical-equipment-market
The document proposes an Android-based mobile application called the E-Nursing System. The application allows registered users to call the nearest ambulance by pressing a help button on their phone. It will also notify the user's favorite emergency contacts and the closest hospital. When help is requested, the app uses the user's location data from GPS to notify the nearest ambulance. It also sends an alert message to the hospital to prepare for arrival. The proposed system aims to provide fast emergency assistance to users by streamlining communication between patients, ambulances, and hospitals.
Aerosol Delivery Devices Market by Product Type, Distribution Channel, End Us...IMARC Group
The global aerosol delivery devices market size reached US$ 44.4 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 63.3 Billion by 2028, exhibiting a growth rate (CAGR) of 5.4% during 2023-2028.
More Info:- https://www.imarcgroup.com/aerosol-delivery-devices-market
Remote Patient Monitoring Market PPT: Trends and Dynamics, Drivers, Competiti...IMARC Group
The global remote patient monitoring market size reached US$ 1.3 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 3.0 Billion by 2028, exhibiting a growth rate (CAGR) of 15.4% during 2023-2028.
More Info:- https://www.imarcgroup.com/remote-patient-monitorning-market
The document describes MedRPM, an open source framework that uses the iPhone as a central device for remote patient monitoring. It allows collection of health data from sensors and patients, and sharing of data with care providers. The goal is to lower costs and accelerate adoption of remote patient monitoring solutions to address issues like rising healthcare costs and physician shortages. The framework includes software on the iPhone and web, as well as smart motes that can monitor patients' homes and environments.
Remote Patient Monitoring Market PPT 2022: Size, Growth, Demand and Forecast ...IMARC Group
Looking forward, the remote patient monitoring market value is projected to reach a strong growth during the forecast period (2022-2027).
More info:- https://www.imarcgroup.com/remote-patient-monitorning-market
Cyber Insurance Market Growth, Demand and Challenges of the Key Industry Play...IMARC Group
The global cyber insurance market size reached US$ 9.8 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 31.7 Billion by 2028, exhibiting a growth rate (CAGR) of 22.39% during 2023-2028.
More Info:- https://www.imarcgroup.com/cyber-insurance-market
Digital Dose Inhaler Market PPT 2022: Industry Trends, Share, Size, Demand an...IMARC Group
Looking forward, the digital dose inhaler market value is projected to reach a strong growth during the forecast period (2022-2027).
More info:- https://www.imarcgroup.com/digital-dose-inhaler-market
IRJET- A Review Paper on Android based Personal Healthcare CompanionIRJET Journal
This document summarizes a proposed Android-based mobile application called Baymax that aims to improve communication between patients and doctors. The application would allow patients to conveniently record health measurements and access medical records, and allow doctors to view patient records and provide instructions. It describes the need for electronic health records to replace manual paper records. The proposed system would use an Android app for both patients and doctors, connected to a real-time database, to securely share health information and improve healthcare management.
Cyber Insurance Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and O...IMARC Group
The global cyber insurance market size reached US$ 11.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 58.9 Billion by 2032, exhibiting a growth rate (CAGR) of 18.8% during 2024-2032.
More Info:- https://www.imarcgroup.com/cyber-insurance-market
Personal Protective Equipment Market PPT 2022: Size, Growth, Demand and Forec...IMARC Group
According to the latest report by IMARC Group, the global personal protective equipment market reached a value of US$ 63.0 Billion in 2021.Personal protective equipment (PPE) refers to a gear that is generally utilized in medical settings to aid in minimizing the chances of contracting infections. It acts as a barrier between the body and infectious materials, including bacterial and viral contaminants. PPE mainly includes various wearable gears, such as glasses, gloves, shoes, muffs or earplugs, respirators, helmets, vests or full bodysuits.
The IDMP Challenge - Whitepaper on ISO IDMP by CunesoftV E R A
The updated whitepaper on ISO IDMP - learn what you need to know during this transition. And how Cunesoft's cune-IDMP can help your organization: https://cunesoft.com/en/products/idmp/
eDiscovery Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Opport...IMARC Group
The global eDiscovery market size reached US$ 12.4 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 20.0 Billion by 2028, exhibiting a growth rate (CAGR) of 8.39% during 2023-2028.
More Info:- https://www.imarcgroup.com/ediscovery-market
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