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

Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.

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

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

Medical Equipment Expo

India International Medical Equipment Expo – Invitation Dec 11th – Dec 13th 2021

Announcement from Andhra Pradesh Medtech Zone

Dr Jitendra Sharma, MD & CEO, AMTZ is inviting you to the IIME Expo, scheduled to happen from the 11-13th Dec 2021 , hosted at Kalam Convention Centre, Vizag, celebrating 3 years of completion of AMTZ.

A unique platform for Medical devices & Equipment manufacturers, Hospital Infrastructure and consumables to meet and network with the Medical Fraternity including Hospital Owners/Management, Consultants, Surgeons & Physicians, Speciality centres etc under one roof.

Exhibitor Product Profile

Profile of exhibit based on Sutures & Sealing Devices, Patient Monitoring Devices, 3D Printers, Machines / Systems, Medical Furniture, Surgical Equipment, Endoscopy Equipment, Dialysis Machines, Lab Equipment, Consumables, Uniforms/Garments, Autoclave, EtO, Drapes, Surgical Equipment, Endoscopy Equipment, Manikins, Gloves, Drug Delivery / Extraction disposables, X-ray, Ultrasound, Digital Imaging, Helicopters & Private Jets, EMS Technology Solutions.

The event will see dignitaries from the Government of India, champions of med-tech, business leaders and hospitals congregating to celebrate our collective success. 

Venue :
India International Medical Equipment Expo 2021
Sat, 11 Dec 2021 – Mon, 13 Dec 2021
Kalam Convention Center
Visakhapatnam, India

Kalam Convention CenterAMTZ Campus, Pragathi Maidan, Siddeswaram, Nadupuru Reserve Forest, Visakhapatnam, Andhra Pradesh 530032

Directions – https://maps.google.com/maps/dir//Kalam+Convention+Center+AMTZ+Campus,+Pragathi+Maidan+Siddeswaram,+Nadupuru+Reserve+Forest+Visakhapatnam,+Andhra+Pradesh+530032/@17.6297358,83.1590403,16z/data=!4m5!4m4!1m0!1m2!1m1!1s0x3a396d5bec015829:0xf36d219478d9473f

Looking forward to seeing you.

Book Your Booth Now : https://lnkd.in/gRAd8rBa

Downloads:

E- Brochure: https://lnkd.in/gZUE2v-H
Floor Lay-out: https://lnkd.in/g8WK3cZq
Branding Opportunities: https://lnkd.in/geXQqNbu

Contact Co-ordinate:

Mr Harish
Director- ICEXPO
+91 8977924225)

Regulation of IVF clinics

Lok Sabha passed bill to Regulate IVF clinics

The Lok Sabha has passed the The Assisted Reproductive Technology (Regulation) Bill, 2020 that proposes the Establishment of a National Registry and Registration Authority for all Clinics and Medical Professionals serving in the field.

Health Minister Shri Mansukh Mandaviya, while moving the Bill for passage, said several suggestions of the Standing Committee have been considered by the Government to improve the legislation.

The Bill seeks to Regulate and supervise Assisted Reproductive Technology (ART) Clinics and ART banks, prevent misuse, adopt safe and ethical practices and so on.

Many such ART Clinics have been running without Regulation. A need was felt for regulation of such Clinics as there are implications on health of those who undertake the procedures, Mr Mandaviya told the House.

The Bill also has a provision that those involved in trafficking and sale of embryos will be fined ₹10 lakh at first instance and in second instance, the person can be imprisoned for up to 12 years.

SInce Surrogacy bill is pending in the Upper House & that has not been passed, Health Minister said both the Bills would now be taken up in the Upper House together.

Bill passed by Loksabha can be downloaded from here

Source – http://164.100.47.194/Loksabha/Legislation/billspassed.aspx

https://www.thehindu.com/news/national/lok-sabha-passes-bill-to-regulate-ivf-clinics/article37790488.ece