NABH has released Notification on May 30,2022 on launching its new portal for 5th edition Hospital Accreditation Standards w.e.f. 01.06.2022
The new portal is designed in a manner to ensure objectivity, transparency, seamless functioning and a faster turn-around time. It also incorporates use of mobile applications to ensure real-time assessment process supported by objective evidence.
All the NEW APPLICANTS under the hospital accreditation programme are requested to register on the new portal w.e.f. 01-06-2022 via the link https://hcoaccreditation.nabh.co
The new portal is to be used only for the hospital accreditation programme, the other accreditation programs will continue to run on the existing portal.
Workshop –Cum-Training program on Pharmacovigilance
Indian Pharmacopoeia Commission is organising a Workshop cum Training Programme on Pharmacovigilance for NABH Accredited Hospitals on Monday, July 11, 2022 between 9 am to 1 pm at Shekhar Hospital, Uttarpradesh
Total seats: 50, Registration will be accepted based on first come first serve basis.
Registration fee is Rs.1180 inclusive of GST. Last date for registration is July 6 2022.
Hospital Empanelment Module (HEM)-Diagnostic Center Registration under AB PM-JAY – Announcement from NHA
Guidelines on Process of Registration for Diagnostic Centres AB PM-JAY has been empanelling hospitals till now. Whatever services were required for providing the care to patients had to be provided by the hospital – either in-house or through outsourcing. With the advent of Corona pandemic and foreseeing the requirement an important step in the diagnosis of the ailment, a need was felt to expand the testing capacity for the benefit of AB PMJAY beneficiaries, hence the packages for diagnostics testing are been notified by NHA. Also. after the request of industry NHA has decided to start registration of the diagnostic centers (Laboratory & Radiology). NHA has developed the module to register the diagnostic centers.
The following are the requirements for registration of the diagnostic (Laboratory & Radiology) center
Licenses/ Certificates: i. Diagnostic Centre Registration Certificate as per state/UTs laws ii. NABH certificate iii. NABL certificate (as applicable) iv. AERB Registration & License v. PCPNDT Certificate (If applicable) vi. CGHS/ECHS empanelment document vii. Government Hospital Diagnostic Centre a) Declaration on letter of appropriate authority/head of institution (Medical Superintendent or dean)
Process for Application:
The centers can apply through HEM platform for registration with AB PM-JAY.
Hospital Empanelment Module(HEM)-Diagnostic Center Registration under AB PM-JAY . NHA has released a Self Help Guide for Hospitals to complete the empanelment processes.
Guide comprises of the following information :
❖ Account Creation ❖ Diagnostic Center Basic Information ❖ Financial Details ❖ Specialties Offered ❖ Investigations ❖ List of Hospitals ❖ Licenses and Certificate ❖ Check Eligibility and Submit
Before submitting the registration request, the authorized diagnostic center representative has to create an account through which detailed information will be submitted. The steps for creating the account are given in the Self Help Guide created by NHA which is shared below for reference.
Download the Self Help Guide for the Empanelment Process.
This is to inform all Healthcare Organizations registered under Hospital (HCO) and Small Healthcare Organizations (SHCO) accreditation programme that QCI-NABH has initiated a third-party feedback mechanism post assessment.
With regard to the above, Hospitals may get a call from the QCI call centre regarding the feedback of the assessment.
Co-operation from partner HCOs and stakeholders is solicited
TECHNICAL BENCHMARKING GUIDE ON COVID-19-RELATED PERSONAL PROTECTIVE EQUIPMENT – Technical Regulations and Standards for PPE in select markets
Covid 10 pandemic has disrupted the global supply chain for PPEs (intended for medical use). Pandemic led confusion has created chaos and supplies became border less to tide over the crisis period requirements. Emergency Use Authorizations were the order of the day in many countries to ensure seamless supply of Medical PPEs across the globe.
This was also the time when markets have realised that there was not much clarity on Technical Standards, Regulations in use across the globe. This void due to lack of knowledge, single guideline document has led to more confusion and chaos to the supply chain. Covid 19 is still not over and markets continue to experience waves after waves with rise of new variants and masking up remains a constant requirement.
In support of the International Finance Corporation’s (IFC) Global Health Platform, IFC launched a Global Advisory Program on PPE in 2020, with funding and support from the UK government’s Foreign, Commonwealth and Development Office (FCDO). The program’s main objective is to support the diversification of global supply chains for PPE and to work with manufacturers and governments in developing countries to increase the manufacturing and supply of quality PPE in those countries. One critical knowledge gap was a guide that compares technical regulations and standards for PPE across countries.
This technical bench marking guide forms a key part of IFC’s Global Advisory Program and provides manufacturers and purchasers with a tool to navigate through the technical regulations, product specifications and conformity assessment requirements associated with selected markets around the world.
The guide focuses on medical PPE, excluding protective equipment and professional workwear to protect workers in other industries, outside health care.
Overall, the guide seeks to simplify comparisons between the various COVID-19-related PPE categories and markets by using a system of color coding to highlight similarities and differences.
For those who need more detail, it also takes a deeper dive into the technical regulations, product standards, and testing criteria for each PPE/market combination.
Document can be downloaded from the following link :
Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022)
Chandigarh Chapter, PHDCCI is organizing 4th in the MDR-17 Series, Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022) as per the following schedule:
Day & Date: Friday, 24 June 2022 Time: 2:30 pm to 5:00 pm Platform: Zoom
Session Highlights • Regulation of medical devices and recent amendments • Steps to Licensing for Class A & Class B Devices/Products • QMS requirements for Medical Devices • Demonstrating Product Compliance as per MDR-17 • Challenges faced by Medical Devices Manufacturers
Key Speakers • Dr. Ravi Kant Sharma, Deputy Drugs Controller, Ministry of Health & Family Welfare Government of India, New Delhi • Mr. M G Sathyendra, Consultant & Trainer – Global Certifications • Mr. Hemant Bhardwaj, Founder & President, Global Medical Devices Experts Foundation • Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat • Dr. Sanjiiiv Rehlan, Chief Executive Officer, Shalex Overseas & Member, Association of Indian Medical Device Industry (AIMED), New Delhi • Ms. Rama Venugopal, President, Consultants Consortium of Chennai & Executive Director, Value Added Corporate Services (P) Ltd., Chennai
National Conference on “Management & Ensuring Safety of Medical Devices” on 9th July 2022
Objective & Targeted audience:
This training program is organised to sensitise among Biomedical/Service engineers from State/Union territory medical services Corporation, Biomedical engineers working in government/private/corporate sector in southern India, Biomedical engineering students & other stakeholders to initiate the reporting mechanism and to ensure active participation in reporting incidents related to medical equipment.
Accreditation: Sustainability in Economic Growth and the Environment, focuses on how accreditation supports the United Nations Sustainable Development Goals – (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.
#WAD Celebrations – an annual initiative from Consultants Consortium of Chennai (CCC)
CCC has been organising series of Knowledge Sessions for the benefit of the industry during WAD Month since its inception. WAD 2020 and WAD 2021 were well received by the industry. We had conducted virtual learning sessions during this period.
WAD 2022, however would be a Hybrid Session. We are planning to organise a physical session in University Auditorium in Chennai with a target audience of around 100 -150 members (offline) and plus online viewers.
IASis a nonprofit, public-benefit corporation that help organizations demonstrate compliance and competence to their customers, regulators and the public. IAS has been providing accreditation services since 1975. IAS accredits a wide range of companies and organizations including governmental entities, commercial businesses, and professional associations. IAS accreditation programs are based on recognized national and international standards that ensure domestic and/or global acceptance of its accreditations.
IAS also maintains signatory status in a number of global multilateral recognition arrangements under Asia Pacific Accreditation Cooperation (APAC), International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC). IAS is a member of the ICC Family of Solutions.
As one of the leading accreditation bodies in the United States, IAS is a signatory to the three primary international organizations that form a unified system for evaluating and recognizing competent accreditation bodies worldwide.
Bureau of Indian Standards
BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. BIS has been providing traceability and tangibility benefits to the national economy in a number of ways – providing safe reliable quality goods; minimizing health hazards to consumers; promoting exports and imports substitute; control over proliferation of varieties etc. through standardization, certification and testing
Keeping in view, the interest of consumers as well as the industry, BIS is involved in various activities as given below:
Standards Formulation Product Certification Scheme Compulsory Registration Scheme Foreign Manufacturers Certification Scheme Hall Marking Scheme Laboratory Services Laboratory Recognition Scheme Sale of Indian Standards Consumer Affairs Activities Promotional Activities Training Services, – National & International level Information Services
Conference Theme :
Sustainability in Economic Growth and the Environment -How accreditation supports the United Nations Sustainable Development Goals (SDGs) 6, 7, 8, 9, 11, 12, 13, 14, 15.
Conference Sessions are built for multiple sectors touching upon the Sustainability Initiatives in various sectors and applicability of various Standards, Certifications, Accreditations , Regulations to ensure that Sustainable Products and Services are offered to Consumers.
Sustainability is a Trade Issue and World Markets are linking World Trade to Sustainability initiatives adopted by various countries.
ESG is based on standards set by lawmakers, investors, and ESG reporting organizations (e.g., GRI, TCFD, MSCI), whereas Sustainability Standards — while also set by standards groups like GHG Protocol — are more science-based and standardized.
Dates : June 9th and 10th 2022 – Thu & Fri Time – 10 00 am – 5 45 pm IST Session Mode – Hybrid (Online and Physical) Venue – Auditorium inside Anna University Campus
Who should attend ?
Sessions would be open to Accreditation Bodies, Certification Agencies, Conformity Assessment Bodies, Inspection bodies, Govt organisations, Members of Trade & Industry Associations, Chambers of Commerce, Entrepreneurial Hubs, MS Consultants, Technical Experts, Startups, Innovators
Sessions at a glance :
Program Agenda Day 1 – Inaugural Session
Open to all stakeholders in Conformity Assessment.
Industry, ABs, CBs, CABs, Inspection bodies, Consultants, Technical Experts, Industry Associations, Innovators, Start-ups, Entrepreneurial Platforms, Government organisations.
There is NO REGISTRATION FEE
However prior registration is a must for participation.
ICMR Survey on Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program
Request for Participation In ICMR’s Landscape Study For Medical Device And Diagnostics under Product Ignition & Development Enabler (mPRiDE) Program of Medical Device and Diagnostics Mission Secretariat, ICMR
The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.
ICMR has always attempted to address itself to the growing demands of scientific advances in biomedical research on the one hand and to the need of finding practical solutions to the health problems of the country, on the other.
The Indian Medical device market is currently valued at USD 11.2 billion and is experiencing a growth rate of 15% CAGR as against growth rates observed by developed countries of about 4% CAGR. India is dependent on imports for its medical device needs with 80% of medical devices being imported. In view of the huge import, dependency and long technology development cycle of medical devices, there is an urgent need for providing holistic support across the medical device development and commercialisation cycle including R&D, scale-up, validation, regulatory compliance, market access etc.
To cater to the above challenges, ICMR has established Medical Device and Diagnostics Mission Secretariat (MDMS) with a vision to support and catalyze research, development and indigenous manufacturing of cost effective medical devices to strengthen health care sector in India and reduce import dependency through a Mission mode consortia approach. ICMR-MDMS aims to conduct a multipronged landscape study inviting medical professionals working at both Government and Private Institutes to provide their opinion on the medical device and diagnostic products as they are the Key Opinion Leaders and the end users of the products.
The objectives of the study are:
(i) To identify various medical devices/sub-sectors/verticals based on unmet healthcare needs and contribute to import dependency in the Country with inherent potential for societal impact. (ii) To strategize, categorize, prioritize, and plan devices/sub-sectors/verticals for extending funding support in a phased manner initially focussing on low end devices, which can deliver volumes and then graduating to high end devices as the program progresses, for accelerating unmet need driven devices and diagnostics product development for wide societal impact. Medical professionals in both Government and private medical colleges/ institution are requested to fill the virtual survey form. The form can be accessed through the link given below. A guidance document is also enclosed for your kind perusal for assisting in filling up the form.