ICMR Survey

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.

Link for the Medical Device form : http://103.25.130.160/icmr-survey/
Link for Invitro Diagnostic Devices Form: http://103.25.130.160/icmr-survey/niform.php

Date of Submission:
Start Date: 3rd Feb’ 2022 Time: 09:00 AM
End Date: 25th Feb’20202 Time: 05:00 PM

In case of any query you may contact the following officials:
Medical Device and Diagnostics Mission Secretariat (MDMS)
Indian Council of Medical Research
Ansari Nagar, New Delhi- 110029
Email: suchita.markan@icmr.gov.in,
icmrmdmsoffice@gmail.com,
div.itr.icmr@gmail.com
Telephone No.: +91-11-26588895 Ext-337

Source : https://main.icmr.nic.in/sites/default/files/whats_new/Landscape_participation_request_03022022_1.pdf

OHSAS Standard

Webinar on OHSAS Standards for Businesses – Jan 28th 2022, Friday – 4 PM – 5 30 PM

Covid 19 outbreaks still continue and businesses struggling with hybrid work options.

Businesses and Enterprises have the responsibility to protect the health and safety of their workers.

Helping employees return to work, safely and confidently, during the coronavirus (COVID-19) pandemic is no easy task for any organisation.

Creating a Safer Work Place is the need of the hour and businesses have to focus on introducing Safe Work Place Practices, Systems to offer an assurance to the employees that they continue to work on safer environment and work place has provision to take care of their health and wellbeing.

Many Businesses focus on growing their business responsibly. That means safety is not negotiable – it’s their number one priority.

Safety is about people – caring about people, and ensuring their wellbeing, is the foundation of what it means to be a sustainable business. 

Global Markets have started releasing OSH, OHSAS guidance documents for businesses to follow. Proposed Labour Code in India – OSH Code, also mandates work place health and safety of employees.

Considering the need to provide more assurance to Employees to return to work, to remain working in a safe work place, businesses have started looking for Tools, Guidelines etc to implement best practices to address these needs. Occupational Health and Safety Standard is an International Standard that helps businesses to implement well defined Management Systems to protect employees health and wellbeing.

Andhra Chamber of Commerce is organising a Program on OHSAS by inviting Team from Bureau of Indian Standards to present OHSAS Standards requirements to the industry . This is a Knowledge Sharing Session from Andhra Chamber of Commerce.

Andhra Chamber invites participation from the industry , business units of all sizes to register for the same.

There is no participation fee and the session is open to industry and other stakeholders too.

Program Details :

Date – Jan 28th 2022, Friday
Time – 4 00 PM – 5 30 PM

Regn Link :

https://us02web.zoom.us/meeting/register/tZ0vde2tpjsrHtJ76ZF3jJsvM-CzpqeogaJ4

Contact Details :

Secretariat – Andhra Chamber of Commerce
andhrachamber1@gmail.com
044 – 24315277/78/79

NABH Announcement

Announcement from NABH – Revising Standards for Entry Level Certification Program for Hospitals & Accreditation Program for SHCO

PUBLIC NOTICE FOR COMMENTS ON DRAFT 2ND EDITION ENTRY LEVEL HOSPITALS CERTIFICATION STANDARD

NABH is in the process of revising standards for Entry level certification of Hospitals. The revision standards have been drafted.

The comments, suggestions, objections in the draft document are invited from public at large, including the stakeholders like hospitals and other clinical establishments, industry, consumer groups, etc. The comments may kindly be shared on the form within 15  days of publication of this notice on the website.

The last date for sending the comments is 31st January, 2022.

Click here to view the Draft Entry Level Standards for Hospitals – 2nd Edition

To fill the Feedback form pleases click on below link

https://docs.google.com/forms/d/e/1FAIpQLSd3bxRY0pfbxGllhueC3AsrXcCW8jQ_bCI_ueklowc-KQ7ezA/viewform?usp=sf_link

Download the Announcement from NABH Here

PUBLIC NOTICE FOR COMMENTS ON DRAFT 3rd EDITION SMALL HEALTHCARE ORGANISATION (SHCO) ACCREDITATION STANDARD

NABH is in the process of revising standards for Small Healthcare Organizations Accreditation Program. The revision standards have been drafted.

The comments, suggestions, objections in the draft document are invited from public at large, including the stakeholders like hospitals and other clinical establishments, industry, consumer groups, etc. The comments may kindly be shared on the form within 15  days of publication of this notice on the website.

The last date for sending the comments is 31st Jan 2022

Click here to view the Draft Small Healthcare Organizations Accreditation Standards 3rd Edition

To fill the Feedback form pleases click on below link

https://forms.gle/cAEKa6MZbm5g1RgJA

Download NABH Notification from here

InformationUpdate

Industry Information Updates – Healthcare Sector

NABH Announcements

Announcements from NABH – Fee Remittance Norms & Communication Matrix to be followed by all Applicant / Certified / Accredited Healthcare Organizations

Announcement 1 – Fee Remittance Notification

Kind Attention : All applicant / Accredited / Certified Health Care Organisations under all programs of NABH

In continuation to the previous notice of NABH related to fee payments  issued  on February 16, 2021, many Healthcare Organisations associated with NABH, are still making direct payment to Quality Council of India – NABH. NABH is facing d i f f i cu l t y in reconciling the amounts received directly as the details of payment are also not updated by the respective HCOs in their online portal.

To avoid unnecessary wastage of time  and  manpower  in  tracking  the  payments, NABH advises its stakeholders to  make payments  only through  the online portal  using the Payment Gateway  so that the payments  are appropriately  tracked  for  convenience  of all the parties.

In order to facilitate the Healthcare  Organisations  to reconcile  the fee payment  status,  NABH is requesting all the HCOs to follow the below steps with immediate effect:

  1. The HCOs a r e advised to login into their HCO account on the NABH portal for making payments through payment gateway via credit card/debit card/net banking.
  • HCOs are advised to refrain from depositing cash/cheque/DD directly into  any  account of Quality Council of India.
  • In case the HCO has no other option but Bank Transfer (NEFT/RTGS), it shall be responsibility of the HCO to update the transaction details like Unique Transaction Reference (UTR) Number, Date of Transaction, Transaction Amount, etc  on  the NABH Portal under the Make Payment category and inform NABH that the Payment was done and get the receipts generated for the payments made.
  • The HCOs are also requested to ensure that the payment details with respect to fee payments of current and previous accreditation cycles have been updated on the NABH portal account of the HCO, if not done earlier.

QCI-NABH plans to stop direct payments into its accounts done through DD/Cheque/Cash Deposit/Offline Bank Transfer (NEFT/RTGS) by March 31, 2022 and is seeking the cooperation from HCOs in this regards.

Download the notification from NABH here

Announcement 2 – Communication Matrix Released for the benefit of all Applicant / Certified / Accredited HCOs

NABH has earlier issued NABH communication matrix – NABH/Notification/Communication/2020/2049 dated 25th September 2020

All the applicant and accredited/ certified HCOs that are listed in the NABH portal have the provisions for making communications with the officials of NABH through “REMARKS COLUMN”. All HCOs are requested to utilise “REMARKS” for communicating/ raising queries regarding status of their applications for accreditation/ certification to ensure transparency as well as for records.

HCOs are also requested to refrain themselves from communicating through emails or telephonically. It is practically not possible to reply to each mail or phone call individually. Moreover, neither your communication nor reply from NABH is captured for the case record purpose.

In case, the queries of the HCOs submitted through remarks on the portal are not replied within three working days, emails to Program Heads may be sent, along with contents of email copied at on-line portal remark column. The list of all programs of NABH and the responsible Program Head with contact details are listed in the notification released by NABH.

Download the notification from NABH

Source : https://nabh.co/index.aspx

BIS LICENSES FOR MASKS AND PPES 

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES – UPDATES FROM BIS

Industry and stakeholders are invited to refer the same . With the continuous spread of many variants of Sars Cov 2 , the global focus is again shifted to using Masks, protecting healthcare workers with coveralls etc. Global Call of Action is again shifted back to providing high quality masks which offer more protection to all users. BIS has released Standards for Coveralls and revised licensing guidelines too for the Indian Industry to follow.

BIS LICENSES FOR MASKS AND PPES

S.NoIndian StandardProductBIS Licenses
1IS 9473:2002Filter Half MasksClick here
2IS 16289:2014Surgical Face MasksClick here
3IS 5983:1980Eye ProtectorsClick here
4IS 17423:2020Cover AllClick here 

REVISED GUIDELINES FOR ISSUE OF LICENSES

S.NoIndian StandardProductProduct Specific
Relaxation guidelines
Product Manual
1IS 9473:2002Filter Half MasksClick hereClick here
2IS 16289:2014Surgical Face MasksClick hereClick here
3IS 5983:1980Eye ProtectorsClick hereClick here
4IS 17423:2020Cover AllClick hereClick here

Source : https://www.bis.gov.in/index.php/bis-licenses-for-marks-ppes/

BIS has released IS 17423 : 2021 – Medical Textiles — Bio-Protective Coveralls — Specification (First Revision) recently. This is the latest Product Standard for Coveralls to be followed by Industry.

BIS has compiled list of all published Technical Standards for Medical Textiles , totally 70 Standards (TXD 36) for industry reference as mentioned below :

TXD 36 – Technical Textiles for Medtech Applications

Refer the List – https://www.services.bis.gov.in:8071/php/BIS/PublishStandards/published/standards?commttid=MTM0

Hospital Accreditation Program

New Accreditation for Private Hospitals offering Maternity Services

To help mother-to-be choose private hospitals which lays emphasis on supporting her choice to breastfeed her baby, a new initiative has been launched for accreditation of private hospitals offering maternity services.

Under this initiative, Breastfeeding Promotion Network of India, a 30-year-old organisation, for protection promotion and support of Breastfeeding in India, and Association of Healthcare Providers of India (AHPI), comprising 12,000 private hospital including maternity centres, has entered into a strategic partnership and launched ‘National Accreditation Centre for Breastfeeding Friendly Hospitals’.

Source :

https://www.newindianexpress.com/cities/chennai/2021/dec/18/new-accreditation-for-pvt-hosps-offering-maternity-services-2396809.html

Upcoming Training Programs

Upcoming Training Programs Calendar from QCI TCB Division

Programs Calendar Announcement from QCI TCB Division

Greetings from The Quality Council of India (QCI)! 

With pleasure, Training and Capacity Building (TCB) Cell, QCI informs that we have received an overwhelming response for our virtual training/courses scheduled in this quarter. As we have received registration in an abundance for the month of November 2021 thus, we had to close a few of our courses due to the limited availability of seats. Appreciating the response, we have decided to announce new batches of virtual training in December, January & February. Please check the list below- 

Requirements of ISO/IEC 17065:2012 for Product Certification Bodies 29-30 Nov 2021 Registration   Open INR 5000 +GST 
Requirements of ISO/IEC 17020:2012 for Inspection Bodies  20-21 Dec 2021 Registration   Open INR 5000/-   + GST (18%)
Laboratory System and Internal Audit program as per ISO/IEC 17025:2017$$ 25-26 Nov 2021  06-07 Dec 2021 Registration Closed INR 5000/-   + GST (18%)  
28-29 Dec 2021 Registration   Open 
ISO/IEC 17025:2017 – Risk Management requirements & implementation in Laboratories 15 Nov 2021 Registration Closed INR 2000/-   + GST (18%) 
22 Dec 2021 Registration   Open 
Uncertainty of Measurement and Decision Rule as per ISO/IEC 17025:2017 16-17 Nov 2021  22-23 Nov 2021 Registration Closed  INR 3500/-   +GST (18%)  
13-14 Dec 2021 Registration   Open  
Medical Laboratory System and Internal Audit program as per ISO 15189:2012$$  03-04 Mar 2022 Registration   Open INR 5000/-   +GST (18%)  
Lean Six Sigma Green Belt Certification 10-12 Feb 2022 Registration   Open INR 9500/-   +GST (18%)  

 

$ We also have eLearning modules for these courses, available at www.equest.co.in to raise your further competence. Once you complete both courses, you will get an additional ‘Competence Certificate’

The courses are designed for professionals like quality & senior management professionals from Inspection Bodies, Laboratories, Certification Bodies, Regulators, Government Bodies, Industry, PSUs, Consulting Organizations, Consultants, Training Organizations, Trainers etc. 

As we do not compromise on quality, we believe keeping a limited number of participants for the training courses will give sufficient opportunities for you all to participate in discussions and clarify doubts. 

After the completion of the course, all the participants will be issued a certificate of participation. 

Grab this opportunity as registration is accepted on the one come one serve basis. 

For this summer, we have launched various other trainings in the general domain as well.  

Fundamentals of Digital Marketing  18 November’21 
Organizational Values, Ethics & Office/Work Place Etiquettes 4 December’21 

Register yourself at the earliest by clicking on the link- http://bit.ly/virtualequest 

On eQuest (www.equest.co.in )we have an array of courses on domains such as Environment, Laboratories, Quality, Agriculture, Healthcare, and Technology-related fields. 

We have recently launched a new course developed by NABL ‘Program for Potential / Accredited / Applicant Proficiency Testing Providers on ISO/IEC 17043:2010” – the program designed for PT Providers to know about standard ISO/IEC 17043:2010 “Conformity Assessment – General requirements for the proficiency testing”.  

For registration and payment related queries, please contact,  
Rohit Varshney, Associate, TCB, QCI, rohit.varshney@qcin.org, Ph- 9773500376 

For any other queries, please write to  
Alok Jain, Director TCB, QCI, ajain@nabl.qcin.org, Ph. 9811352698  
Ranvijay Bihari, Dy Director, TCB, QCI, ranvijay.nabet@qcin.org, Ph. 8800424788 

This information is shared here as information update and for the reference of the industry.

Outcome of COP26 for India and Abroad

Outcome of COP26 for India and Abroad – Webinar from Service Export Promotion Council

Announcement from SEPC :

We are Organising a webinar on COP26. A business unit can sell its carbon points and gets incentives on financing and special offers in most of the member countries.

Any kind of environmental steps that a company takes is monetary benefit to them, especially if they are exporting. How to do this can be learnt through this session . Plus there will also be a session on all services and incentives by SEPC.

Registration Link

https://us02web.zoom.us/webinar/register/WN_LBV79wNvRyOaFET1oIRidQ

Materiovigilance Programme of India

Webinar on Key role of Medical Technology/ Medical Device Industries in Materiovigilance Programme of India

Materiovigilance Programme of India, Indian Pharmacopoeia Commission!    

Program Announcement from IPC

Indian Pharmacopoeia Commission (IPC), an Autonomous Institution of Ministry of Health and Family Welfare, Government of India functions as National Coordination Centre (NCC) for Materiovigilance Programme of India (MvPI) since January 2018 with the primary objective of ensuring patient/user/third party safety from medical devices and IVDs. Materiovigilance Programme of India (MvPI) has the responsibilities to monitor, collate and analyse the adverse event associated with use of medical devices in Indian population and suggesting regulatory bodies to take appropriate action.

NCC-MvPI is jointly organizing a webinar entitled “Key role of medical technology/ medical device industries in Materiovigilance Programme of India” in association with CDSCO and AIMED on December 10, 2021 via digital/virtual platform.

The objective of the webinar is to spread awareness on materiovigilance among marketing authorization holders (MAHs) including Importers, distributors of medical devices and healthcare professionals across India in order to strengthening of the materiovigilance pan India.

In this regard, we are requesting you to participate or kindly nominate officials who are associated with post marketing surveillance of medical devices in your organization. You can also percolate this information to other appropriate organizations so that they will get benefited. We look forward to your support for making this event a grand success.

The necessary information is attached herewith for your reference.

Who should attend ?

Manufacturers, Distributors, Importers, Regulators of medical devices, Healthcare Professionals and Researchers can attend this webinar.

Registration Details :

  • Registration fee: Rs. 7 000 /- (Including 7 8% CST) per participant.
  • Registration maximum for 7 00 participants will be accepted, based on “First come first serve basis”.
  • Payment shall be made by NEFT/Online mode to Indian Pharmacopoeia Commission, Bank of
    Baroda, Sanjay Nagar, Ghaziabad, Bank Account Number: 27 860 7 000 7 3540, Branch IFSC Code: BARBOSANGHA (fifth character is zero), Type of Bank Account: Super Saving, MICR Code of Bank: 7 7007 2204.

Regn Enquiry :
Mr. Maneesh Soni
NCC-MvP1, IPC : +91-9977484175
E-mail: mvpi.ipcindia@gmail.com

For more information:
https://www.ipc.gov.in/news-highlights/904-webinar-on-key-role-of-medical-technology-medical-device-industries-in-materiovigilance-programme-of-india-in-association-of-cdsco-and-aimed.html

Contact :
Dr. Shatrunajay Shukla, Ph.D., M.S. (Pharm.)
Materiovigilance Programme of India (MvPI)
Indian Pharmacopoeia Commission
(Ministry of Health & Family Welfare, Govt. of India)
Sector-23, Raj Nagar, Ghaziabad-201 002, India
Mobile: +91-8840864320,9643460668
(+91)-0120-2800500; 2783400; 2783401
Fax: 0120-2783311
Website: www.ipc.gov.in