Internal Auditor Training Program As Per Iso 13485:2016 Standard
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
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
Conference on“Industry 4.0 for MSMEs” on 23rd August 2023, Wednesday
The adoption of Industry 4.0 technologies, such as automation and IoT, is essential for the manufacturing of MSMEs in the future. These technologies provide substantial advantages, such as increased visibility, productivity, competitiveness, and efficiency, all of which are essential for MSME manufacturers to maintain their lead in the global market. MSME manufacturers can successfully adopt Industry 4.0 principles and modernize their processes to satisfy future demands.
Considering the importance of this, Andhra Chamber of Commerce in association with Friedrich Naumann Foundation for Freedom is organizing a Conference on “Industry 4.0 for MSMEs” on the 23rd August 2023 in Hotel Hyatt Regency, Anna Salai, Chennai from 10 a.m. to 4 p.m.
The learnings of the Conference will
make the MSMEs more competitive
make the MSMEs more attractive to the younger workforce
make the team stronger and more collaborative.
allow the MSMEs to address potential issues before they become big problems.
allow the MSMEs to trim costs, boost profits, and fuel growth
As the participation is only on the first come first served basis, please fill up the registration form and send it to Andhra Chamber of Commerce at the earliest.
Unlocking Opportunities: NISM XXIII – Social Auditors Certification Webinar
Discover the potential of becoming a Social Auditor with the newly launched NISM XXIII: Social Auditors Certification Examination. In her 2019 Budget Speech, Finance Minister Nirmala Seetharaman announced the launch of the Social Stock Exchange in India.
Building on that, SEBI issued ICDR, LODR & AIF regulations through gazette notifications in July 2022. NSE and BSE have already introduced dedicated social stock exchange segments on their platforms.
Under the aegis of The Institute of Chartered Accountants (ICAI), the Institute of Social Auditors of India (ISAI) has been established (https://isai.ca.in/ ) as a Self-Regulatory Organization (SRO).
ISAI will play a crucial role in enrolling, regulating, and developing Social Auditors.
To explore the opportunities and significance of this certification in shaping the future of Social Auditing, please register yourself for the Webinar.
Date and Time : Sat, Jul 22, 2:30 PM – 4:00 PM GMT+5:30
UGC paves way for university-industry partnerships for research, paid internships, funds
To encourage research through industry partnerships in universities, the University Grants Commission (UGC) has drafted guidelines on sustainable and vibrant university-industry linkage for the institutions.
The draft guidelines on Sustainable and Vibrant University-Industry Linkage System for Indian Universities recommend creation of Industry Relation Cell or IRC at the universities and University Relation Cell at companies for collaborations.
The main objective of the IRC, as per the guidelines, is to enable collaborative project creation between a university faculty group and an industry group. Its responsibility will be to identify research topics, including topics relevant to the local area, identify potential research problems for industry and the university, explore funding sources for the research among others.
It also suggests creating a “cluster of universities and industries” enabled by technology at state level led by institutions of state or central government in each region.“ Each cluster may create a technology centric mechanism to capture the local problems and then assign the same as projects to the students based on the infrastructural cum human expertise available at the host institute of a student,” the ugc guidelines state.
To facilitate this, the guidelines encourage joint development of new technologies in research labs of the universities or educational institutions to benefit technology transfer.
The guidelines further facilitate roping in professors of practice to facilitate collaboration between industry partners at the universities.
Endowment, degrees by industry partners
The industry, as per the guidelines, can provide endowments to create advanced facilities and vocational training centres as per the requirement of the industry or for the cause of education.
It allows industry partners to help university students to use “sophisticated and costly equipment” available in industry and open access of university resources for industry partners for testing and certification.
According to the draft, industries can also establish industry chairs in universities and support scholarship schemes to attract meritorious young researchers to university.
To make students job-ready, the guidelines recommend offering collaborative degree programmes tailored for industry personnel or with emphasis on practice. Project work under this programme can be executed under joint guidance of the teachers and experts from industry on generic or industry problems, the guidelines states.
Internship and apprenticeship
Apart from research collaborations, the draft guidelines also bat for internship and apprenticeship opportunities. University can introduce internship or apprenticeship irrespective of the field including Arts, Science and Engineering as per the UGC Curriculum and Credit framework for programmes. The internship related credits will be awarded based on the credit framework.
Universities will be free to decide the number of internships and types of internships with the approval of statutory authorities. A faculty member will be assigned to handle and coordinate the internships related to the academic programme.
The guidelines further encourage firms to offer paid internships to students and put in efforts in making the internships sustainable. To safeguard students’ interest, the guidelines also have provision for companies to ensure accident insurance protection for the participants.
CME on PHARMACOLOGY – TOPIC : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES on 15th July 2023
Government of Karnataka Shri Atal Bihari Vajpayee Medical College & Research Institute, Bengaluru formerly called Bowring & Lady Curzon Medical College & Research Institute, DEPARTMENT OF PHARMACOLOGY jointly organised with NCC-MvPI, IPC & RTC-MvPI NIMHANS, Bengaluru conducting CME on 15thtJuly 2023
Topic : TO ENSURE PATIENTS SAFETY ON ADVERSE REACTIONS OF DRUGS AND MEDICAL DEVICES
Mode : Hybrid
Time : 9 am to 4 pm
Fee : Rs. 200
Venue: Lecture Hall 3, SABVMCRI, Bengaluru
Contact : Dr. Nishitha S B @ 9591040864
Who can register: Medical, Dental, Nursing, AHS , Paramedical, Pharmacy, AYUSH, Physiotherapy – faculty/Students, Health Department Officials & Industry Professionals
DoP releases strategy document to fine tune & implement National Medical Devices Policy
In an effort to fine tune and proceed with the implementation of the National Medical Devices Policy, 2023, launched in the month of May, the Department of Pharmaceuticals (DoP) has come out with an elaborate strategy document which emphasises on data security measures, adoption of national nomenclature for medical devices, a strategy to manage e-waste of obsolete medical devices and strengthening of technology transfer capabilities in the sector.
It would also work towards providing awareness to the innovatory community on regulator compliance, early on in the product development cycle through structured programmes using course curriculum, skill training or workshops, it said.
The NMDP, 2023 covers six broad areas of work for the promotion of the medical devices industry including regulatory streamlining, enabling infrastructures, facilitating research and development and innovation, attracting investments in the sector, human resource development and brand positioning and awareness creation.
As part of infrastructure development, the strategy document states, “”In close coordination with the ministry of environment, forest and climate changes, processes will be developed for e-waste management of obsolete medical devices”.
“The Policy strives to create an ecosystem to promote Research and Innovation in the sector under the ambit of the department’s proposed separate ‘Policy to Catalyse R&D and Innovation in the Pharma-MedTech Sector in India’”
Besides, a mechanism will be put in place to hand-hold the innovators and IP holders towards commercialisation of the products
Under the fiscal and non-fiscal measures to attract investments in the sector, it looks at incubation support for start ups in the R&D and innovation, mentorship for entrepreneurs along with skill development, such as business management, market access and commercialisation efforts for the innovation solutions developed, technology transfer mechanism for innovative solutions and relations for start-ups in compliance and regulatory regime.
Under the human resources development strategy, it envisages that since the human resources in the field of design are limited, the National Institutes of Design (NID) and private design schools will be encouraged to teach design centric courses to fill the gap, it added.
Commerce ministry authorises EPCMD to issue registration-cum-membership certificates for exporters
The Commerce Ministry has authorized the newly-established Export Promotion Council for Medical Devices (EPCMD) to issue registration-cum-membership certificates for exporters of specific medical items. These items include bandages, first-aid boxes, hot water bottles, ice bags, gloves, surgical garments, syringes, and stethoscopes.
A Registration-cum-Membership Certificate (RCMC) is required for exporters to avail benefits under the foreign trade policy, as well as customs and excise benefits
Holding the certificate can also help exporters in availing benefits with respect to customs and excise.
These items also include hot water bottles, ice bags, gloves, personal protective garments for surgical/medical use, surgical gowns and drapes, syringes, with or without needles, and stethoscopes.
The directorate general of foreign trade (DGFT) in a public notice stated that the council has been included in FTP for “issuing RCMC for specific items”.
The Ministry of Power notified the Carbon Credit Trading Scheme, 2023 whereby the governance of Indian Carbon Market and direct oversight of its functioning will be done by the National Steering Committee for Indian Carbon Market
1. The National Steering Committee shall recommend to Bureau the following functions:
for the formulation and finalisation of procedures for institutionalizing the Indian carbon market;
for the formulation and finalisation of the rules and regulations for the functions of Indian carbon market;
for the formulation of specific greenhouse gases emission targets for the obligated entities;
for the formulation and finalisation of guidelines regarding trading of carbon credit certificates outside India;
to issue carbon credit certificate;
for the development of the process or conditions for crediting period or renewal or expiry of carbon credit certificate;
to monitor the functions of Indian carbon market;
to constitute any Committee or Working group as required in connection with Indian carbon market; and
any other functions assigned to it by the Central Government.
2. The Chairperson shall call the meeting at least once in a quarter of every year.
The bureau, in its role as administrator, will carry out the following tasks:
(a) to identify sectors and potential for reduction of greenhouse gases emissions in such sectors and recommend to the Ministry of Power to include such sectors in Indian carbon market;
(b) to develop trajectory and targets for the entities under compliance mechanism;
(c) to issue the carbon credits certificate based on the recommendation of the National Steering Committee for Indian carbon market and subsequent approval of the Central Government;
(d) to develop market stability mechanism for carbon credits;
(e) to develop the procedure for accreditation and functions of accredited carbon verification agency;
(f) to accredit the agencies in accordance with the approved procedure for accredited carbon verification agency;
(g) to determine, the fees and charges payable by the registered entities with the approval of Central Government, for the purposes of meeting the cost and expense towards the implementation of this Scheme;
(h) to develop the process or conditions for crediting period or renewal or expiry of carbon credit certificates;
(i) to develop data submission formats, forms for effective functioning of Indian carbon market;
(j) to undertake capacity building activities for the stakeholders;
(k) to develop and maintain the information technology infrastructure including the user guidance platform required for Indian carbon market;
(l) to maintain secure database with all security protocols as approved by the Central Government;
(m) to constitute any Committee or working group as recommended by the National Steering Committee for Indian carbon market; and
(n) any other functions assigned to it by the Central Government.
The Central Electricity Regulatory Commission as a regulator to Indian Carbon Market shall perform the following functions:
(a) to regulate matters relating to trading of carbon credit certificates;
(b) to safeguard interest of both sellers and buyers;
(c) to regulate frequency of carbon credit certificates trading; and
(d) to provide market oversight and take necessary preventive and corrective actions to prevent fraud or mistrust
The Bureau shall constitute, one or more Technical Committees for different areas as required under compliance mechanism for the purposes of this Scheme
The Bureau with prior approval of the Central Government shall determine the procedure including eligibility criteria for accreditation of any agency to function as accredited carbon verification agency based on the recommendation of the National Steering Committee for Indian carbon market
The sectors and the obligated entities to be covered under the compliance mechanism shall be decided by the Ministry of Power based on recommendations of the Bureau;
The sectors and the obligated entities to be covered under the compliance mechanism shall be decided by the Ministry of Power based on recommendations of the Bureau
The National Steering Committee for Indian carbon market and other authorities shall develop the detailed procedure for operationalising the Indian carbon market, in accordance with this Scheme. The detailed procedure shall contain the following, namely: –
criteria for issuance of carbon credit certificates;
validity of carbon credit certificates;
floor and forbearance price of carbon credit certificates;
requirement, format and timeline for submissions;
monitoring, reporting and verification; and
any other related and incidental matters.
The Bureau may, from time to time, issue such directions and orders to the registered entities, with the approval of the Central Government, as considered appropriate for the implementation of this Scheme.
