Medical Device Regulations – Materiovigilance Program of India – News Letter from IPC
News Letter from IPC on Materiovigilance Program is shared below for information.
Since Medical Devices are brought under Full Regulations in the country, one of the mandatory Regulatory Requirement is Market Surveillance by Regulator .
Read the news letter shared below for more information
Invitation to All to join WSD 2023 Celebrations
Oct 14th is Celebrated World over as World Standards Day.🎊
CCC(Consultants Consortium of Chennai) and MSCC(Management Systems Consultants Consortium) are organising a webinar on Oct 14th 2023 from 4 pm–5 pm.🗓️
WSD Theme this year : Shared Vision for a better World – Incorporating SDG 3
SDG 3 is all about Good Health and Wellbeing 👩🏻⚕️
In alignment with Global Theme,we have scheduled a webinar on the following topic:
Healthcare Quality Assurance – Standards ✅
ISO has released a Healthcare QMS Std – ISO 7101, for the first time globally.🏥
Pharma Sector is witnessing Global MS Standards in Pharma Manufacturing as well💊
Medical Devices Sector is racing towards implementing MDQMS 🩺
Session on Healthcare Quality Assurance is designed to Educate Healthcare Sector – be it Services or Products , and various other stakeholders, about various Healthcare Quality Assurance Standards which are introduced globally to improve the Healthcare Quality Focus across the globe.
Healthcare Services can’t offer Assurance on its Quality when its Supply Chain, Value Chain Quality is not in alignment with its Quality Assurance Framework.
Time to LEARN, UNLEARN and RELEARN 🧑🎓
Prog Info :
Date : Oct 14, 2023
Time : 4 pm – 5 pm
Meeting Mode : Zoom Meeting
Fee – No Fee. Free for all 🆓
Registration Link :https://us02web.zoom.us/meeting/register/tZwsd-uhrD8rHdXTn3awk0eCxcSxAzqqSg20
Prior registration is a must. All registered delegates will receive direct mail from ZOOM, CCC Secretariat and also a SMS.
For Prog info, updates, visit – https://ccc-consultants.org/world-standards-day-2023/
For queries , pls mail :
CCC – contact@ccc-consultants.org
MSCC – info@msccglobal.com
World Standards Day (WSD) -14 October 2023 – Session by QAI
World Standards Day is celebrated globally on Oct 14 every year.
Global Theme for this year is on: Shared vision for better world: Incorporating SDG 3 (Good Health and Well Being)
Quality and Accreditation Institute (QAI) is Celebrating WSD 2023 by organising a one Hour Session based on the Global Theme on 14 October 2023 between 11 AM to 12 PM.
The session will be held in Virtual Mode (Webinar).
Registration Link: https://us02web.zoom.us/meeting/register/tZ0vceGhrzwqHdRVwoCTgdFgh559fLKH8pVN
After registering, you will receive a confirmation email containing information about joining the meeting.
Join hands to celebrate the day.
IBSC (Indian Biomedical Skill Consortium) is conducting Internal Auditor Training Program on ISO 13485:2016 – Medical Device Quality Management System
COURSE OUTCOMES:
a. Use of ISO13485:2016 as the basis for a QMS for medical device manufacturers
b. Ways to increase effective manufacturing of medical devices and cost savings through quality management
c. Supply chain monitoring to achieve continuous improvement·
d. Understanding how to meet regulatory requirements leading to increased patient safety
Duration: 3 Days (12th, 13th & 14th October 2023)
Mode: Online (Hybrid mode)
Eligibility: Any (Working Professionals & Interested Student
Discount: 25% to AMTZ Manufactures; AiMeD Members, IBSC Partners
For quotation send email to n.nareshkumar@ibsc-amtz.in
Program Details: https://www.ibsc-amtz.in/coursedetails/30
Last Date for Registration: 7th October 2023
For more information, please contact :
Mr. Nitturi Naresh Kumar
WhatsApp: 918897330990
n.nareshkumar@ibsc-amtz.in
Regulatory Awareness & Experiential Learning Workshop for Medical Device / Diagnostic Innovators / Start-ups in India
Indian Council of Medical Research (ICMR)is conducting a Regulatory Awareness & Experiential Learning Workshop for Medical Device/Diagnostic Innovators/Start-ups in India jointly with Central Drugs Standard Control Organisation (CDSCO) on 12th Oct 2023 at ICMR Hqrs, New Delhi.
Date of the Workshop – 12th October 2023
Time – 10 am to 5 pm
Venue – Conference Hall, ICMR Hqrs, New Delhi
Mode of workshop – Hybrid mode
Last Date for Registration – 30th September 2023
Registration Link – https://docs.google.com/forms/d/e/1FAIpQLSeQZCq00-CnvqpG-tUZRHF43fc3gthxkGvVSl-3KP9FrmKyqw/viewform
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.
For more information about Expo, visit – https://hospex.in/
All Conference details are available at – https://hospex.in/hospex-2023-conference/
Contact :
T S Soumya, Hospex
+91 9080078447
Email – reach@hospex.in
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 :
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
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 :
Contact Details :
For more information about Conference, visit – https://hospex.in/hospex-2023-conference/
For more information about Expo, visit – https://hospex.in/
For support in registration, reach out to :
Ms Soumya – 9080078447
Email – reach@hospex.in
ESG for transformational affordable housing
Environment, Social and Governance are the three facets that characterise sustainable responsible investing for any organisation.
The rise of ESG standards in construction industry is expected to create a resilient and successful marketplace with long-term benefits fo stakeholders through a coordinated attempt to reduce the negative impacts on the environment.
The ESG framework for construction projects is developed in similar lines to the green building certification requirements, making green buildings a subset of it. The following are the key ESG parameters considered for any construction project:
| Environmental | Social | Governance |
| Energy savings and carbon emissions offset | Labour health, safety and environment | Enforcement of labour laws |
| Waste and Water management | Gender inclusion | Awareness of staff welfare and benefits |
| Resource efficiency through reducing, reusing, and recycling | Community engagement and buyer satisfaction | Fair payment terms and company policies |
| Occupant well-being and indoor environment comfort |
ESG provides a holistic strategy to enable a builder to gain understanding on the negative environmental and social impacts of their housing projects. For example, construction waste generated on site must be segregated and disposed of in a responsible manner.
Additionally, safety signages should be displayed in the local language of the construction workforce and mandating usage of PPE for them
It also enables the typically first-generation developers in the affordable housing segment to strengthen their corporate governance policies. For example, maintaining regularised wages and working hours for construction workers on site. Provision of a creche facility at the construction site to educate the construction worker’s children along with enforcing relevant policies to strengthen the prohibition of child & forced labour practices.
Infusing the concepts of ESG to create best practices for the construction sector will further help in achieving India’s climate target to reduce Emissions Intensity of its GDP by 45 % by 2030. This will further be a small step towards achieving India’s long-term goal of reaching net zero by 2070.2
So far India’s climate mitigation actions have been mostly financed from domestic resources. However, to address the challenge of climate change and achieve the Nationally Determined Contributions (NDC), there is a need for new and tailor-made funding required. Such funding opportunities are now coming in form of green bonds and climate finance from Development Finance Institutions to Indian banks and NonBanking Financial Companies (NBFCs).
The role of ESG is crucial to achieve the targets under India’s Panchamrit plan. To achieve this, real estate investors and lending companies should ensure that financing is aligned with positive and measurable climate, social and environmental co-benefits
Govt releases Guidelines for scheme for Assistance to Medical Devices Clusters
The Department of Pharmaceuticals (DoP) has come out with the guidelines for the scheme for Assistance to Medical Device Clusters for Common Facilities (AMD-CF) with proposed financial outlay of Rs. 300 crore to offer financial assistance to strengthen the existing and new medical device clusters through creation of common infrastructure facilities
The Scheme, with two sub-schemes, is expected to help in boosting the domestic manufacturing capacity and improving the quality of clusters for sustainable growth of the medical devices sector.
The scheme further intends to support central or state governments, institutions, or organisations to establish or strengthen the testing laboratories for medical devices to meet the needs arising due to the roll out of the licensing regime of the Medical Devices Rules (MDR), 2017.
The Scheme has two components or sub schemes – Assistance for Common Facilities (CF) and Assistance for Testing Facilities (TF) – and would be running for three years from 2023-24 to 2025-26. The tenure of the scheme is from the financial year 2023-24 to the financial year 2026-27.
Both 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 (Rs. 48 crore in the first year, Rs. 128 crore in the second and Rs 64 crore in the third year) for the common facilities and Rs. 60 crore (Rs. 18 crore for the first, Rs. 30 crore for the second and Rs. 12 crore for the third year) for the testing facilities.
Assistance for Common Facilities is planned to strengthen the medical devices clusters’ capacity for their sustained growth by creating common infrastructure facilities.
Medical devices manufacturing units in a cluster who have come together to form a Special Purpose Vehicle (SPV) to execute the project of developing common facilities and the clusters promoted by the State governments, are expected to benefit from the sub-scheme.
There shall be a minimum of five medical device manufacturing units as members of SPV. Clusters promoted by state governments may not need to form an 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.
For Common Infrastructure Facilities for medical device clusters, the limit of support will be 70 per cent of the approved project cost or Rs. 20 crore, whichever is less, as per the approval of the Scheme Steering Committee (SSC).
The sub scheme is expected to have benefits including improvement in quality of medical devices, regulatory compliance specified for medical devices, increased availability of trained personnel for the clusters, increased competitiveness of units in the cluster and reduction in the manufacturing cost of the devices.
The sub scheme on assistance for Testing Facilities is aimed at strengthening availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices, and national or state level government of private institutions interested to establish or strengthen testing facilities for medical devices to test Class A, B, C and D medical devices including in vitro diagnostic medical devices under MDR, 2017 can apply for the assistance.
The guideline proposes a Technical Committee constituted by the DoP to assist the SSC, which will have one representative each from the Central Drugs Standard Control Organisation (CDSCO), industry and academia, and ICMR, and two representative experts having knowledge and experience in the process development, R&D, product design, testing of medical devices or medical devices manufacturing from relevant institutes such as NIPER, IISc, IITs, Sree Chitra Thirunal Institute of Medical Sciences and Technology, and CSIR, among others.
The DoP will provide overall policy, coordination and management support for the implementation of the Scheme, while the proposals under the scheme will be considered for approval by the SSC, which will be headed by the Secretary of DoP as the Chairperson, and will have members including the Drugs Controller General of India, Financial Advisor of DoP, Joint Secretary (Schemes and Medical Devices), DoP, representatives of the Ministry of Micro, Small and Medium Enterprises (MSME), the Ministry of Electronics and Information Technology (MeitY), the Department for Promotion of Industry and Internal Trade (DPIIT), and the director or the deputy secretary (Schemes) of the DoP.
Certified Digital Health Professional (CDHP) course
The CDHP™ is jointly offered by the leading institutions across Digital Health and Management – Digital Health Academy and Indian Institute of Management (IIM) Raipur
Certified Digital Health Professional’ (CDHP) course blending the fields of Health, Technology and Management, will equip clinicians, paramedics, healthcare professionals, and managers to understand the Digital Health domain and the deployment of digital health tools.
Ideated in 2020 by Digital Health Academy, CDHP is the result of two years of research, brainstorming, and extensive consultation with around 60 global leaders across the healthcare domain working in hospitals, the pharmaceutical industry. research & development, med-tech, information technology, regulators, and policy makers across the countries. The course is a unique blend of the world’s best faculty and use cases in digital health. This Course jointly offered by Digital Health Academy and Indian Institute of Management, Raipur.
The year-long course will be completely online specifically designed for healthcare and management professionals. The CDHP course has three levels; Basic, Advanced and Professional. This course aims to provide knowledge on theoretical, technological, management and application aspects of digital health acorss the continuum of care.
The course certificate will be awarded by IIM Raipur and Digital Health Academy
ISO 13485:2016 – Lead Auditor Training Program (Medical Device Quality Management Systems )
Indian Biomedical Skill Consortium (IBSC) is conducting Lead Auditor Training Program on ISO 13485:2016 standard.
Program Details are given below:
Program: ISO 13485:2016 – Lead Auditor Training (Medical Device Quality Management Systems )
Certificate: CQI & IRCA Certified Course
Duration: 5 Days (23rd – 27th January 2023)
Last date for Registration : 12th January 2023
Location: Kalam Convention Center, AMTZ Campus, Vizag
Program Details: https://ibsc-amtz.in/coursedetails/23
For quotation send email to n.nareshkumar@ibsc_amtz.in
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For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in
