CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017
Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.
Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf
NHA issues hardware guidelines for healthcare institutions at State/ UT level to facilitate effective implementation of Ayushman Bharat Digital Mission
The National Health Authority (NHA) issued hardware guidelines across States and Union Territories for healthcare institutions like hospitals, clinics and health and wellness centres to promote digitization in hospitals.
The guidelines provide a basic framework to States/UTs for planning, assessment and procurement of the IT hardware (including IT specifications of various hardware equipment) to operate applications compliant with Ayushman Bharat Digital Mission (ABDM).
The guidelines on the IT hardware specifications to support this ecosystem is available at https://abdm.gov.in:8081/uploads/Hardware_Guidelines_ABDM_e162cf7a7b.pdf. The document will help the States/ UTs in assessing the hardware requirements while planning and procurement of IT assets for healthcare institutions of all scales.
The guidelines published by NHA is suggestive and recommendatory in nature. States/UTs and the health facilities have the flexibility to modify these guidelines based on local requirements and circumstances.
Source: Posted On: 22 AUG 2022 4:17PM by PIB Delhi
source link: https://pib.gov.in/PressReleseDetailm.aspx?PRID=1853603
Public Notice on Medical Devices Standards from Department of Pharmaceuticals
Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.
Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .
Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.
Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .
Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.
Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.
Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical
Exposure Draft on Compendium of Social Audit Standards issued by ICAI
In order to regulate the profession of Social auditors, the Sustainability Reporting Standards Board of ICAI has developed the draft preface to the social audit standards as specified in the notification dated July 25, 2022 issued by SEBI .
“Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) (Third Amendment) Regulations, 2022” dated July 25, 2022, has been issued in The Gazette of India regarding formation of Social Stock Exchange . The notification defines Social Stock Exchange as “A separate segment of a recognized stock exchange having nationwide trading terminals permitted to register Not for Profit Organizations and/ or list the securities issued by Not-for-Profit Organizations in accordance with provisions of these regulations.”
As per the above notification, The Institute of Chartered Accountants of India (ICAI) has been entrusted with the responsibility of being Self- Regulatory Organization for regulating the profession of Social auditors
In this regard, Sustainability Reporting Standards Board of ICAI has developed following :
• (i) Draft Preface to the Social Audit Standards
• (ii) Draft Framework for the Social Audit Standards
• (iii) Draft Social Audit Standards (SAS) on all the sixteen thematic areas specified in the above mentioned notification.
The downloadable version of the Exposure Draft is available at: https://resource.cdn.icai.org/71191srsb57193.pdf
Comments on this exposure draft are sought by ICAI latest by August 26, 2022
Source: https://www.icai.org/post/srsb-ed-compendium-of-social-audit-standards-for-comments
Heal in India – Govt plans interpreters, special desks at 10 airports for ease of overseas patients
‘Heal in India’ – Government is likely to announce the initiative on August 15 2022.
The ‘Heal in India’ initiative aims to positioning the country as a global hub for medical and wellness tourism.
Interpreters and special desks at 10 airports, a multi-lingual portal and simplified visa norms are going to be the highlights of the government’s ‘Heal in India’ initiative to boost medical tourism.
The government has identified 44 countries, predominantly African, Latin American, SAARC and Gulf countries from where a large number of people visit India for medical purposes. The 10 identified airports — Delhi, Mumbai, Chennai, Bengaluru, Kolkata, Visakhapatnam, Kochi, Ahmedabad, Hyderabad and Guwahati — see higher footfalls of patients from these 44 countries
The Health Ministry, in collaboration with the National Health Authority, has developed a multi-lingual portal which would be a one-stop shop for services provided by medical travel facilitators and hospitals with an interface for foreign patients. The portal is also likely to be launched on August 15.
The portal will display standardized package rates based on the classification of hospitals and different systems of medicines including modern and traditional systems. It will also have a grievance redressal section as well as an option to submit patient feedback.
There will also be a mechanism to track patient journey by creating a unique health ID under the Ayushman Bharat Digital Mission framework and monitor service delivery in identified health facilities in India
Source:https://m.timesofindia.com/business/india-business/heal-in-india-govt-plans-interpreters-special-desks-at-10-airports-for-ease-of-overseas-patients/articleshow/93408941.cms
Food Safety and Standards Regulations, 2022 – Notification – 34456/2022/REGULATION-FSSAI
FSSAI has issued a Notification (34456/2022/REGULATION-FSSAI) containing draft of certain regulations which the Food Safety and Standards Authority of India proposes to make in super session of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016
These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.
Articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purpose and shall be clearly distinguishable from foods intended for normal consumption by their special composition.
Categories covered under these regulations include: (a) Health Supplements (HS) (b) Nutraceuticals (Nutra) (c) Food for Special Dietary Use (FSDU) (d) Food for Special Medical Purpose(FSMP) (e) Prebiotic food and Probiotic food (Pre-Pro)
The draft regulations shall be taken into consideration after the expiry of the period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public.
Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or sent on email at regulation@fssai.gov.in
Source link: https://www.fssai.gov.in/upload/uploadfiles/files/Draft_Notification_Health_29_06_2022.pdf
School of International Biodesign-Synergising Healthcare Innovation and Entrepreneurship (SIB SHInE) fellowship 2022 – 2023 Program
Calling out to passionate graduates for DBT’s prestigious Biodesign Program Fellowship
IIT Kanpur and KGMU Lucknow jointly are inviting applications for School of International Biodesign-Synergising Healthcare Innovation and Entrepreneurship (SIB SHInE) fellowship program
About SIB SHInE Program
The program is based on the philosophy of 4Cs ie.., Clinical Immersion, Conception, Creation and Corroborations.
The year-long fellowship will provide the fellows an in-depth understanding of biomedical product development – from the identification of clinical opportunities to the initiation of a new venture.
Access SIB SHInE Program Brochure:
Know more: https://www.sibshine.com/
Deadline: 29th July 2022 (Midnight)
Contact:
SIB SHInE
IITK KGMU Biodesign Program
sib_shine@iitk.ac.in
Address:
SIDBI Building, Indian Institute of Technology, Kanpur, 208016
TiECON Chennai 2022, the 15th edition of TiE Chennai’s Flagship Conference
TiECON Chennai 2022, the 15th edition of TiE Chennai’s flagship conference, is scheduled on October 7 and 8, 2022. Returning to an in-person format after the COVID-19 pandemic, the conference promises to host several speaker sessions and networking opportunities for entrepreneurs from Tamil Nadu and beyond. This year’s conference will delve deep into the changing entrepreneurial ecosystem brought by the pandemic and its after-effects. Specifically, this conference will delve into into the very DNA of a robust entrepreneurial venture – resilience. Over the course of two days, we will engage with the complexities of this resilience, exploring what it looks like and how it can be nurtured. Together, we will debate, discuss and deliberate this idea of resilience. Anchored around the theme ‘Resilience Unlimited,’ TiECON Chennai 2022 promises to set the stage for entreprises of the future.
For the 15th annual TiEcon Chennai 2022 – October 7 & 8, 2022
October 7, 2022 – Workshops 10:00 am to 5:00 pm & Awards Evening 7:00 pm On wards…
October 8, 2022 – Conference 9:00 am to 6:00 pm & Parallel Sessions 11:00 am to 6:00 pm
Smart entrepreneurs never miss out on opportunities to grow. That is why you should sign up for TiECON Chennai 2022 now! Early bird registrations are closing soon! Hurry up and grab your seat at TiECON Chennai 2022 to get inspired by industry stalwarts and business leaders par excellence!
Sign up for TiECON Chennai 2022 Now!
Register Now : https://tieconchennai.com
For Stall Bookings Kindly fill the form: https://forms.gle/fDy75HxJWi4EaiPs5
Contact:
IIT Madras Research Park,
Kanagam Road, Taramani,
Chennai 600113, Tamil Nadu.
Website: https://tieconchennai.com/
Greetings from Health, Ethics, and Law (HEaL) Institute for Training, Research and Advocacy; and Forum for Medical Ethics Society (FMES), Mumbai.
We with our co-hosts – Indira Gandhi Institute of Development Research (Deemed to be University), Mumbai and Vidhayak Trust, Pune – are pleased to announce our flagship ‘Short-Duration Intensive Training Program in Social Science and Public Health Research Ethics’ on Tuesday between September 6, 2022, and October 25, 2022, (Every Tuesday during this period between 1600 and 1930 hrs on a at virtual platform.). Please note that all sessions will be live ones steered by experts allowing direct interactions between course participants and the faculty and course directors. These are not pre-recorded sessions.
Important dates:
Closing date for receipt of application forms: Monday, August 15, 2022
Selection notification to applicants: Thursday, August 25, 2022
Training program: Tuesdays between September 6 and October 25, 2022
About the course: The course curriculum has a legacy of 15 years to which a number of scholars including those trained in bioethics have contributed. Over time they developed research ethics case studies from the Indian context. These serve as one of the key resources for the course. Because these are live sessions (and not pre-recorded), content of each session is carefully curated to cover contemporary issues and ethical dilemmas building on the most recent scholarship in the concerned thematics.
The course aims to equip course participants with knowledge and skills in research ethics. They would serve on significant human resources to take the learnings to their own ecosystem and facilitate knowledge transfer in research ethics.
This ethics training would help to develop an ability to use moral judgment. This training is aimed at enabling public health students and researchers; and public health practitioners to apply public health ethics frameworks and principles to reason out new, difficult, or ambiguous cases/situations/scenarios toward resolving the issue at hand in morally discerning ways.
Please find enclosed the program brochure and flyer for your ready reference. Watch out for the space on FMES’s HEaL Institute website (https://fmesinstitute.org/) for updates such as session faculty, and additional webinars on special themes.
For any further questions or clarification, please write to us at fmescentre.events@gmail.com or
call on Mob.: 7506265856
Source Link : https://fmesinstitute.org/wp-content/uploads/2022/07/SSPHRE.pdf?utm_medium=email&utm_source=sendpress&utm_campaign
Contact :
Dr Sunita Sheel, Director, HEaL Institute, Mumbai
Prof Srijit Mishra, Indira Gandhi Institute of Development Research, (Deemed to be University), Mumbai
Forum for Medical Ethics Society
O-18, Nav Bhavna Premises Co-operative Society Ltd.
422 Veer Savarkar Marg, Prabhadevi
Mumbai 400 025, India
Fifth Edition India’s Only Practice Development Conference For Ophthalmologists and Eye Hospital Managers
About the Programme :
Ophthall 2022 is the fifth edition India’s only Practice Development Conference for Ophthalmologists, and Eye Hospital Managers. Ophthall 2022 would offer an insight into Practice Development and focus on business of Ophthalmology which regular conferences rarely do.
Though Practice Development is need of the hour, this important subject is not taught in Medical Colleges. The day an Ophthalmologist steps into practice, he becomes an entrepreneur and must play multiple roles which he is not prepared to. Ophthall 2022 will educate the Ophthalmologists about the business skills which are required to run a successful Ophthalmology Practice.
The effective management of an ophthalmology practice is nearly as intellectually challenging – and interesting – as the practice of ophthalmology itself. This practical two-day meet will be a knowledge sharing platform for Ophthalmologists to learn the essential skills of practice development from more than 40 Expert practice development specialists (Industry Experts and Ophthalmologists)
Ophthall 2022 would follow an unconference format and would break all traditional conference formats. We will have TED Talk like sessions, Panel Discussions, Fireside Chats and Round Table sessions which would address all issues of Practice Management and would enable our Delegates to take their practice to the next level.
While attending Ophthall 2022 you will also be able to participate in our Partner Events India Ophthalmology Expo and India International Optical Expo and purchase Equipments and Consumables at specially negotiated price for your Eye Hospital.
Ophthall 2022 will create networking Opportunities for Mentorship, Investment, Partnership and guidance to run a effective Ophthalmology Practice to all attendees.
Programme Date : July 16th & July 17th 2022
Programme Time : 9.30 am – 5.30 pm IST
For More Information about Ophthall 2022 please contact
Mr Hari
M: +91-8754517944
info@ophthall.in
