Notification from NABH – Launching New portal for 5th edition Hospital Accreditation Standards

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 on Pharmacovigilance

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.

AB PM-JAY Announcement

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:

  1. The centers can apply through HEM platform for registration with AB PM-JAY.
  2. Every center willing to get registered will need to visit the web portal, https://hospitals.pmjay.gov.in create an account for themselves.
  3. Once the login ID is created, center shall apply for registration through an online application form on the web portal link available on https://hospitals.pmjay.gov.in
  4. All the required information and documents will need to be uploaded and submitted by diagnostic center through the web portal.
  5. After registering on the web-portal, the center user will be able to check the status of their application.

Download the full document for more information from the link below :

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.

Source : https://pmjay.gov.in/resources/documents

RBI Guidelines

Outsourcing of Information Technology (IT) ServicesDraft Master Direction from Reserve Bank of India

Regulated Entities (REs) have been extensively leveraging Information Technology (IT) and IT-enabled services (ITeS) in their business, products and services with increasing dependence on third parties. Such reliance on IT/ITeS provided by third parties exposes the REs to various risks.

It was announced in the Statement on Developmental and Regulatory Policies, released with the bi-monthly Monetary Policy Statement dated February 10, 2022, that draft guidelines on risk management framework for Outsourcing of IT Services, managing related concentration risk, its periodic risk assessment and aspects of outsourcing of IT Services to foreign service providers, will be issued by the Reserve Bank of India.

Accordingly, the Reserve Bank has released a draft Master Direction on Outsourcing of IT Services, for comments of stakeholders and members of public.

This advisory covers all Registered Entities as listed below :

  • Scheduled Commercial Banks (excluding Regional Rural Banks);
  • Local Area Banks;
  • Small Finance Banks;
  • Payments Banks;
  • Primary (Urban) Co-operative Banks having asset size of ₹1000 crore and above;
  • Non-Banking Financial Companies in Top, Upper and Middle Layers;
  • Credit Information Companies; and
  • All India Financial Institutions (NHB, NABARD, SIDBI, EXIM Bank and NaBFID)

Purpose:
The underlying principle of these Directions is that the RE should ensure that outsourcing arrangements neither diminish its ability to fulfil its obligations to customers nor impede effective supervision by the supervising authority. REs desirous of outsourcing of IT and IT enabled services shall not require prior approval from RBI. However, such arrangements shall be subject to on-site/ off-site monitoring and inspection/ scrutiny by the supervising authority.

These Directions shall apply to material Outsourcing of IT Services arrangements (as
defined in para 1.7 below) entered by the REs.

What the Draft document contains ?
– Applicability
– Purpose
– Service Provider
– Information Technology (IT) Outsourcing
– Material Outsourcing of IT Services:
– Criticality of Outsourcing of IT Services
– RE’s role in Outsourcing of IT Services- Regulatory and Supervisory requirements
– Governance Framework
– Role of the Board
– Role of the Senior Management
– Role of IT Function
– Evaluation and engagement of Service Providers
– Outsourcing Agreement
– Risk Management
– Business Continuity Plan and Disaster Recovery Plan
– Monitoring and Control of Outsourced Activities
– Outsourcing within a Group/ Conglomerate
– Additional requirements for cross-border outsourcing
– Exit Strategy

Comments :
Comments / feedback from REs and other stakeholders may be submitted by July 22, 2022 through email with the subject line ‘Feedback on Master Direction on Outsourcing of IT Services’.

The final Master Direction shall be issued by Reserve Bank after considering the feedback received.

Download the Draft Master Direction Document released by RBI from the button below :

Source – https://rbi.org.in/Scripts/BS_PressReleaseDisplay.aspx?prid=53911

NABH Notification

NOTIFICATION FOR THIRD-PARTY FEEDBACK MECHANISM

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

WAD 2022 Event Update from CCC

World Accreditation Day Conference – Post Event Update

World Accreditation Day Conference 2022 – Post Event Update

WAD 2022 Conference jointly organised by International Accreditation Services (IAS), USA; Bureau of Indian Standards and Consultants Consortium of Chennai ended on June 10th 2022 with a positive a note.

Two days conference held on June 9th and 10th had eminent speakers from India and abroad , from various sectors , sharing rich insights about Standards, Certifications, Accreditations, Inspections & Regulations related to Sustainability and Environment across the globe.

Two days of intense learning sessions came to an end on June 10th.

Conference had 324 delegates registering for multiple sessions across two days and the feedback received from them is very encouraging.

The conference is supported by many Trade and Industry Platforms as listed below :

Sharing few pictures of the event for reference :

Session Videos are shared here for industry and stakeholders benefit. Please check the links below

INAUGURAL SESSION :
Theme – Sustainability in Economic Growth and the Environment

TECHNICAL SESSION 1:
Theme – Sustainable Standards for a Safer World

TECHNICAL SESSION 2 :
Theme – ESG Rating for Sustainability Initiatives

TECHNICAL SESSION 3 :
Theme – Sustainability Initiatives in Food Sector

TECHNICAL SESSION 4 :
Theme – Sustainable Healthcare Initiatives

TECHNICAL SESSION 5 :
Theme – Incorporating Sustainability in Educational Institutions

PPE Guidelines

TECHNICAL BENCH MARKING 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 :

Source – https://www.bsigroup.com/globalassets/documents/ppe/ppe-web-page/technical-benchmarking-guide-for-medical-ppe.pdf

ISO Annual Meeting 2022

Global challenges and technological developments and understand the potential of standards

REGISTRATION IS NOW OPEN for ISO’s must-attend event of the year!

The ISO Annual Meeting is the keystone event in the ISO calendar featuring thematic sessions, networking opportunities, the ISO General Assembly, and much more…

Join a conversation exploring today’s most important global challenges and technological developments and understand the potential of standards as accelerators of change for good.

Connect and network with national standard bodies, industry leaders and international organizations from around the world.

Sign up now – https://lnkd.in/eC47pcXp

PHDCCI Conference

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

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZIpcuGhqT0oE9MghceheO3F_QWzn45B7CTc

You tube link of the session is also appended.
https://youtu.be/1AHq92C_F2A

You may send your questions to rimneet.kaur@phdcci.in prior to the session.
The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

Conference on Medical Devices

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.

Delegate Registration Process :
Registration Fee:
For Industry delegates: Rs 2000/-
For Healthcare professionals: Rs 1000/-
For Students & other stakeholders: Rs 500/-

Last date for registration is on or before 20 June 2022 at 5:00 pm

Registration Link –