Kalam Institute of Health Technology (KIHT), Vizag is organising the 2nd edition of World Health Innovation Forum 2024 at Vizag from December 12th to 14th 2024.
Key Highlights of the Program
a. To Explore Innovation in Healthcare. b. To Create Public Private Partnerships Platform. c. To Support Policy-Making in Healthcare d. To Impact Global Health.
To explore the transformative learning, unparalleled networking opportunities and collaborative initiatives please click the link https://www.whif.kiht.in/registration/ and register for the program.
For additional details on the program, please contact: Email : whif@kiht.in Phone: +91 8341622261
Smart Hospitals Conference 2024 @ Mumbai on 15th March 2024
Smart Hospitals Platform is created to help Business Owners of Small and Midsized Hospitals, Daycare Centers, Clinics etc. LEARN to MANAGE their businesses, in alignment with changing market needs and business scenarios.
Conference this year is designed to create conversations on Growth Opportunities for Healthcare Businesses and Investments the sector is attracting over last few years.
Conference Theme :
Indian Healthcare Services – A Decade Of GROWTH 🡅 Forecast – SMART GROWTH Enablers
𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗢𝗯𝗷𝗲𝗰𝘁𝗶𝘃𝗲 :
A Decade Of Growth Forecast For Healthcare
Indian Healthcare Space has been witnessing a strong GROWTH surge over the last 2-3 years, especially in Tier 1 and 2 Cities in the country. Demand for Quality Healthcare is on the rise and this market need is driving heavy flow of Private Equity Investments into the sector over the last 2-3 years.
Industry Reports say in Indian metros total bed density remains largely uncapitalised and for Quality beds there is a demand-supply gap of 20-30 per cent.
Tier 1 and 2 cities are where a large part of India’s GDP growth is going to happen and they will become a very important growth engine of this healthcare market. Providers of Services prefer to be in the markets where the market needs are not met.
Indian Healthcare Services – 5 Strong Pillars of Growth
Services Growth will be driven by the Convergence of following sub domains providing care delivery through multiple channels :
– Hospitals – Home Care – Diagnostics – Health Insurance – Digital Health
ENABLERS for GROWTH for each sub domain may vary . SMART Hospitals Conference will have speakers discussing about the much needed ENABLERS to Drive the Growth.
Opportunity for Healthcare Service Providers across the spectrum from Tier 1,2,3,4 and 5 cities to join the session and Listen to Experts Opinions, Views on the SMART Growth Enablers that will drive the Sectoral Growth over the next decade.
𝗪𝗵𝗲𝗻 ?
📅 Date: 15th March 2024 – Friday ⏲ Time: 10 00 am – 5 00 pm 🌆 Venue: Bombay Exhibition Centre, Mumbai
𝗪𝗵𝗼 𝗦𝗵𝗼𝘂𝗹𝗱 𝗔𝘁𝘁𝗲𝗻𝗱 ?
Promoters of Hospitals / Other Healthcare Service Organizations (Micro, Small, Medium and Large Organizations) , Medical Professionals / Practitioners , Administrators, Management / Operations Teams, Marketing Teams, Managerial Teams, Technology Teams , Startups, Innovators, HealthTech, MedTech, Digital Health Companies , Investors , Academic Institutions , Innovators, Nursing Professionals, Paramedical Teams, Health Insurers, TPAs, Management Consultants, Finance Professionals and other stakeholders
Addendum to NABL 112 document in respect of ISO 15189:2022 version
ISO 15189:2022 is an international standard that specifies the requirements for quality and competence in medical lab environments. It is a standard that requires labs to develop a robust, reliable quality management system (QMS) to establish their competence.
This standard promotes the welfare of patients and satisfaction of laboratory users.
NABL 112 is a Specific Criteria for Accreditation of Medical Laboratories, prepared by a Technical Committee, which is aligned as per ISO 15189: Medical laboratories- Requirements for Quality & Competence
NABl has released the addendum document to NABL 112. Table specifying the applicability of this document to different clauses of ISO 15189:2022 are given below
ISO 15189: 2022 Requirement
Refer NABL 112 Issue No. 4 Requirements
5.1 Legal entity 5.2 Laboratory Director
Page No. 10 – Organization and management responsibility
6.7 Service agreements Agreement with laboratory users Agreement with POCT operators
Page No. 11 – Service Agreements
6.8.2 Referral laboratories and consultants 6.8.3 Review and approval of externally provided products and services
Page No. 11 – 4 Examination by referral laboratories
5.3.3 Advisory activities
Page No. 12 – Advisory services
8.4 Control of records Creation of records Amendment of records Retention of records
Page No. 13 – Control of records
8.8 Evaluations
Page No. 14 – Evaluation and audits
6.2 Personnel
5.1 Personnel
6.3 Facilities and environmental conditions
5.2 Accommodation and environmental conditions
6.4 Equipment Equipment requirements Equipment acceptance procedure Equipment instructions for use Equipment adverse incident reporting Equipment records
6.5 Equipment calibration and Metrological traceability
6.5.2 Equipment Calibration
6.6 Reagents and consumables Receipt and storage Acceptance testing Inventory Management Instructions for use Adverse Incident Reporting
5.3 Laboratory equipment, reagents and consumables
7.2 Pre-examination processes Primary Sample collection and handling Sample transportation Sample receipt Pre-examination handling, preparation and storage
5.4 Pre-examination processes
7.2 Examination processes Verification of examination methods Validation of examination methods Evaluation of Measurement Uncertainty Biological reference interval and clinical decision limits Documentation of examination procedures
5.5 Examination processes
7.3.7 Ensuring the validity of examination results Internal quality Control External quality assessment Comparability of examination results
5.6 Ensuring quality of examination results
7.3 Post examination processes Reporting of results Post-examination handling of samples
5.7 Post examination processes
7.4.1 Reporting of results Critical result reports Special considerations for results Automated selection, review, release and reporting of results Requirements of reports Amendments to reported results
5.8 Reporting of results
7.4.1.2 Result review and release
5.9 Release of results
7.6 Control of data and information management Authorities and responsibilities for Information management Information Systems management Downtime plans Off site management
International Fellowship on Health technology assessment by KIHT,Visakhapatnam
The 9th International Fellowship on Health technology assessment is being launched by Kalam Institute of Health Technology, Visakhapatnam, to promote the advancement of knowledge and expertise in health technology assessments.
KIHT aims to equip participants with the latest methodologies, best practices, and insights in HTA, empowering them to become leaders in the field.
The 9th International Fellowship on Health Technology is scheduled on 18th to 24th March 2024 at Kalam Convention Center,AMTZ Campus, Visakhapatnam
Program Details are given below:
Date : 18 – 24 March 2024 Time : 9.30 am to 5.30 pm Venue: Kalam Convention Center C/o AMTZ Campus, Visakhapatnam,Andhra Pradesh- 530031
Program Benefits :
– Conceptual Mastery in HEOR – Exclusive Insights into Emerging Trends in HEOR – Proficiency in cutting edge HEOR software – Access to exclusive Research and Training materials – Practical knowledge in Study design, Evidence synthesis and Economic modelling – Exposure to Real world evidence, case studies and applications – Open discussion with Academicians and Industrial Leaders – Benefits of mentorship from World renowned Professionals in the field – Global Networking Precision
Who should attend?
– Healthcare Policy makers and Regulators – Medical Professionals and Practitioners – Health Economist and Researchers – Healthcare Industry and Innovators – Academicians and Students – Hospital Administrators
Assistance to Medical Device Clusters for Common Facilities (AMD-CF)
The Ministry of Chemicals & Fertilizers Department of Pharmaceuticals has issued the Guidelines for the Scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)” on May 9 ,2023 with a proposed financial outlay of Rs. 300 crore
About AMD-CF Scheme
AMD-CF Scheme aims to strengthen the existing and new medical device clusters by providing financial assistance for setting up new testing laboratories for medical devices ensuring quality and sustainable growth for the sector
The Scheme further intends to support Central or State Government/s or Institutions or Organization to establish or strengthen the Testing Laboratories for Medical Devices to meet the needs arising due to roll out of the licensing regime of the MDR, 2017 and ensuring availability of more testing facilities for evaluation of Medical Devices on behalf of the manufacturers, as mandated under MDR, 2017 or as per the amendment thereon, from time to time
The Scheme would be implemented in a Public Private Partnership (PPP) mode through one time grant-in-aid for creation of infrastructure and common facilities. A Special Purpose Vehicles (SPVs) will be set up for this purpose. The SPVs will have a minimum of 3 pharma units (including Bulk Drug and Medical Device Units) as its shareholders. There shall be a minimum of five medical device manufacturing units as members of SPV.
The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV
The outcomes of the Scheme will be reviewed after 2 years from the date of its initiation.
SIDBI has been appointed as Project Management Agency (PMA) for implementation of Scheme.
Components / Sub schemes of AMD – CF Scheme
There are two components / sub schemes to this AMD – CF scheme :
1. Assistance for Common Facilities (CF) : To strengthen the medical device clusters’ capacity for their sustained growth by creating Common Infrastructure Facilities. 2. Assistance for Testing Facilities (TF) : To strengthen availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices
Financial outlay of the Schemes :
The sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore for the common facilities and Rs. 60 crore for the testing facilities
Tenure of the Scheme :
The tenure of the Scheme is from Financial Year 2023-24 to Financial Year 2026-27.
Incentives Under this Scheme :
For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters: the limit of support will be 70% of the approved project cost or Rs. 20 cr., whichever is less, as per the approval of SSC (Scheme Steering Committee). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the CIF, whichever is less
For Testing Facilities (TF) of Medical Device (MD) products,the limit of support will be 70% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, as per the approval of SSC.
In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 5 Crore per Cluster or 90% of the project cost of the CIF, whichever is less.
Any expenditure above the prescribed limit shall be borne by the elected applicant
Benefits of the Sub Schemes are :
i. Improvement in quality standards of medical devices ii. Improvement in regulatory compliance specified for medical device iii.Increased availability of trained personnel for Medical Devices clusters iv.Increased competitiveness of Medical Devices units in cluster v. Reduction in the manufacturing cost of Medical Devices
Notice for Invitation of Applications:
The Department has now invited applications from eligible applicants under the Scheme AMDCF.
Central Government has launched a ‘one-stop-shop’ portal NSWS, designed by Invest India through Tata Consultancy Services (TCS) to streamline the import of medical devices in the country. This will be independent of the existing portals – the SUGAM portal or cdscomdonline portal. The existing portals will be disabled by January 15, 2024
The portal facilitates applications for the certificate of registration and licences to manufacture or import medical devices for various purposes such as clinical investigations, tests, evaluations, demonstrations, or training.
From January 1, 2024, the following three activities under the Medical Devices Rules, 2017 will be made live on the NSWS Portal:
i. application for grant of certificate of registration of a notified body- Form MD -01 ii.application for licence to manufacture medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -12 iii.application for licence to import medical device for clinical investigations, test, evaluation, examination, demonstration or training- Form MD -16
All the stakeholders should submit the application for the above 3 activities, through NSWS portal only
Click the link below to read the detailed guide book on How to apply for CDSCO approval
National Single Window System (NSWS) is a one-stop-shop portal, and a medium of convenient and efficient online Government-to-Business (G2B) services to the business community, which reduces the complexity in obtaining information and services related to starting businesses in India and deals with various approvals, registrations and permits.
NSWS is a portal wherein investors/ entrepreneurs can identify, apply and obtain regulatory approvals and compliances as under applicable laws in India, for setting up and starting a business unit anywhere in India. However, the final authority of giving approvals lies with the Ministry/ Department/ State authorities and the internal process followed by the respective Ministries/ Departments/ States remains the same.
The Know Your Approvals (KYA) module supports information across 32 Central Departments and 17 States. However, there may be other approvals required that the investors may like to check at their own discretion. Currently, the portal hosts applications for approvals from 21 Central Departments and 14 State Governments
Objectives of NSW:
To establish a single-window mechanism by integrating the services provided by various Central Ministries, Departments, and State Governments
To provide a one-stop-shop for procuring pre-establishment and pre-operation approvals and permits required to establish a business in India
To provide efficient, convenient, transparent, and integrated electronic service to investors, industries, and businesses
To provide a uniform and seamless experience to the business user
Benefits of NSW Portal:
All approvals in one place
Transparency
Cost saving
Secure Document repository
Fast query management
Real time status tracking
Easy renewal
Integration with Other systems
NSW contribute to economic growth by reducing trade barriers and improving the overall efficiency of trade processes
Services that can be availed through the NSWS :
Identification of requisite pre-establishment and pre-operation approval for setting up of a business unit in India
Application of suggested approvals
Digital repository for storing documents related to approvals
Payment of processing fees to issue any approvals
Post application, tracking and status update on applications submitted
Easy Renewal
Information about approvals such as timelines, fees, documents required etc.
Who can use this Portal?
The users of a National Single Window (NSW) portal typically include a wide range of stakeholders involved in international trade and logistics. The National Single Window System is designed and built for both foreign and domestic investors/ entrepreneurs of any sector, scale and size.
Traders – Importers, exporters, and other businesses engaged in international trade
Government Agencies
Customs Brokers and Agents
Transport and Logistics Providers
Financial Institutions
Certifying Bodies
Trade Associations and Chambers of Commerce
Information providers
How to use the NSWS portal?
An investor/ Business user is required to register on the National Single Window System (NSWS) by clicking on “Sign Up Now” before applying for any service from the portal. The user requires an email ID and mobile number to register. Once they complete the registration process, they can apply for pre-establishment and pre-operation approvals given by the Ministries/ Departments/ States that are part of the NSWS.
The NSWS does not charge any fee for user registration. However, any fee/ charges required by the Ministry/ Department/ State to process the applications for approvals can be paid through the NSWS portal
On the whole, The National Single Window portal benefits a broad spectrum of stakeholders by promoting efficiency, transparency, compliance, and collaboration in trade processes.
By addressing the diverse needs and interests of traders, government agencies, service providers, consumers, and society at large, an effective NSW system contributes to fostering a more resilient, inclusive, and sustainable trade ecosystem.
HOSPEX Healthcare Expo cum Conferences 2023 – SEP 15-17,2023 at Zamra International Convention Centre, Kochi, Kerala
The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.
Experience the Next Generation of Healthcare at HOSPEX Healthcare Expo in Kerala! Join us as we bring together leading manufacturers and suppliers from the medical industry to showcase cutting-edge medical equipment and innovations. From state-of-the-art imaging technology to advanced surgical instruments, explore the latest advancements that are shaping the future of healthcare.
2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi, Kerala.
HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.
Expo cum Conference Theme this year is on :
Future of Healthcare – Device | Digital | Diagnostics
Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.
HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry.
HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.
The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.
SMART Hospitals Conference
Date : Sep 16, 2023
Time : 10 00 am to 6 00 pm
Fee : Rs 500 per delegate
SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.
Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.
Conference Outline :
SMART Medical Technologies help Practitioners to improve service standards
SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
SMART Prescription for Prescribers – EHR Solution
SMART Technologies to enable Small Hospitals – Technology Session
SMART HealthTech Ecosystem
Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
Smart Healthy Aging Tech Solutions
Target Audience :
Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc
HOSPEX PURCHASE MANAGERS WORKSHOP – FOR BIOMEDICAL TEAMS, PROCUREMENTS TEAMS IN HOSPITALS AND OTHER HEALTHCARE SETTINGS
Venue: Zamra Convention Centre, Kochi, Kerala
Date : September 15, 2023
Time : 2 30 pm – 5 30 pm
Fee – Rs 250 + GST
Target Audience :
Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings
Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .
Workshop shall cover following items that Hospitals Procure with special reference to:
– Biomedical Equipments
– Consumables and Disposables
– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose
Program Objective :
Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)
Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :
Understanding Medical Device Regulations- Laws of the Land
Medical Device Regulations – Role of Bureau of Indian Standards
Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
Claims of Voluntary Certifications – How Authentic these claims are ?
Materiovigilance Program of India – Regulatory Requirement
FDA requires medical devices be secured against cyberattacks
Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. These same features also increase potential cybersecurity risks. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.
Under FDAguidance issued this week, all new medical device applicants must now submit a plan on how to “monitor, identify, and address” cybersecurity issues, as well as create a process that provides “reasonable assurance” that the device in question is protected.
Applicants will also need to make security updates and patches available on a regular schedule and in critical situations, and provide the FDA with “a software bill of materials,” including any open-source or other software their devices use.
As part of the new law, the FDA must also update its medical device cybersecurity guidance at least every two years.
