NABH MITRA PROGRAM – Launch

The NABH MITRA Empanelment Programme has been officially launched to build a nationwide network of verified professionals and organisations (“MITRAs”) who will support hospitals with NABH Accreditation, Certification, and digital health transformation, especially across Tier 2, 3, and 4 cities in India.

The last date to submit applications for empanelment is October 10,2025

About the Programme

The initiative offers a structured, transparent framework for MITRAs—trusted companions to hospitals—who will guide healthcare organisations through quality improvement and digital enablement in line with NABH standards. Empanelled MITRAs will be listed on the NABH website with verified credentials and areas of expertise.

Categories of MITRAs

Digital MITRA: Supports hospitals in implementing NABH Digital Health Standards and IT enablement through structured digital health consultancy. Digital MITRA category has additional training and experience requirements

Organisational MITRAs: Support hospitals for both Full Accreditation and Entry-Level Certification.

Individual MITRAs: Independently support hospitals mainly for Entry-Level Certification.

Who Can Apply:

Individual MITRAs: Qualified professionals with at least one successful accreditation or certification support project and one NABH-certified professional (current assessors not eligible).

Organisational MITRAs: Registered companies, LLPs, trusts, societies, or proprietorship entities operational for at least one year, with experience supporting minimum three hospitals through accreditation or certification. Must have at least two NABH-certified professionals (current NABH assessors not eligible).

Application Process & Fees

i. Apply via the NABH online portal by October 10, 2025.
ii. Shortlisted candidates will be invited for interviews and required training.
iii.Empanelment fee for a three-year period: ₹20,000 + GST (Individual MITRA), ₹50,000 + GST (Organisational MITRA).
iv.Training program charges: ₹25,000 + GST for MITRA, ₹15,000 + GST for Digital MITRA (paid after selection)

Additional Information

i. MITRAs will play a key role in enabling hospitals to achieve NABH standards and strengthen India’s healthcare quality framework
ii. Empanelment does not imply endorsement or financial association by NABH.
iii.Maintaining high standards, transparency, and ethical conduct is compulsory.

Source: https://portal.nabh.co/Announcement/MEP_Concept.pdf

Industry update: Constitution of Medical Device related adverse Event Committee in Medical Colleges

The National Medical Commission (NMC) public notice, dated July 13, 2025, addresses the monitoring, assessment, and prevention of adverse events associated with medical devices through the constitution of a Medical Device related Adverse Event Committee (MDAEC) in each medical college.

Here’s a breakdown of the advisory:

Intent of the Advisory:

The core intent of this advisory is to enhance patient safety and improve the quality of healthcare delivery by systematically collecting, analyzing, and responding to adverse events related to medical devices. It acknowledges that medical devices are crucial in modern healthcare but can cause harm, necessitating a robust monitoring system. The advisory emphasizes the integration of medical colleges into the Materiovigilance Programme of India (MvPI), launched in 2015 by the Ministry of Health and Family Welfare (MoHFW), to monitor these adverse events and risks nationwide. This program aims to provide data to the Central Drugs Standard Control Organization (CDSCO) to support regulatory action and guide improvements in clinical practice.

Role of Medical Colleges:

Medical colleges are identified as ideal hubs for Materiovigilance due to their diverse patient populations and access to advanced healthcare technologies.

The advisory outlines several strategic advantages for medical colleges becoming a Medical Device Adverse Events Monitoring Centre (MDMC), including:

Academic Recognition: Enhancing the institution’s stature as a contributor to national public health and regulatory science.
Professional Development: Providing faculty and students hands-on exposure to post-market surveillance, risk assessment, and patient safety.
Infrastructure Enhancement: Gaining access to MvPI resources, training modules, and national-level collaboration.
Policy Influence: Offering opportunities to contribute to evidence-based recommendations and medical
device regulations.
Patient Safety: Ensuring early detection and response to device malfunctions, directly improving clinical outcomes.

Key Directives for Medical Colleges:

The advisory mandates the following actions for all medical institutions:

Establishment of MDAEC: Each medical institution is advised to set up a committee to monitor adverse events related to medical devices.
Registration with IPC: This committee must be registered with the Indian Pharmacopoeia Commission (IPC). The enrollment form is available on the IPC website.
Website Disclosure: The medical institution’s website must indicate the name of the Coordinator/Convenor and additional members of the committee.
Chairperson: The Medical Superintendent will ordinarily be the Chairperson of this committee.
Registration Date: The website should also indicate the date of MDAEC registration.
Pharmacovigilance Committee Update: Institutions are also reminded to update the names of Pharmacovigilance Committee members on their website.

Timeline: This process has to be completed before July 31, 2025.

Source:https://www.nmc.org.in/MCIRest/open/getDocument?path=/Documents/Public/Portal/LatestNews/Public%20Notice%20dt%2013-07-2025.pdfhttps://www.nmc.org.in/MCIRest/open/getDocument?path=/Documents/Public/Portal/LatestNews/Public%20Notice%20dt%2013-07-2025.pdf

Industry Information Update – HOSPEX–QAI Quality Culture Award 2025

4th Edition of  HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Aug 22nd – 24th 2025. This is Kerala’s first B2B Medical Expo which will take place at KINFRA International Exhibition Centre, Kakanad, Kochi, Kerala

As a part of the Expo, to encourage, nurture the Culture of Practicing Quality in Small Hospitals, Hospex-QAI Quality Culture Award 2025 is designed this year.

About the Award:

The award is a joint initiative of HOSPEX India and QAI.

This award is a recognition of the Quality Focus that is built in Small Hospitals and the efforts taken by Small Hospitals to make Quality a Culture in their clinical settings.

For any Practice to become a Culture needs lot of commitment in any organisation. This award is created to motivate healthcare facilities to come forward and pitch their Quality Practices which have become a Culture in their settings.

About HOSPEX:       

Hospex is the initiative of Trithvam Integris, a company that specialises in managing Health and Medical Fair Events. Hospex is solely focused on digital health, healthcare and organising conferences for the medical industry by a group of doctors.

HOSPEX 2025 is the only Medical & Healthcare Exhibition in Kerala targeting Hospitals, Other Healthcare organisations, Medical Device Manufacturers, Pharmaceutical Manufacturers, Startups, Innovators in Health Tech and Med tech space.

The core focus of HOSPEX Healthcare Expo 2025 (Fourth Edition) is Medical Knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry

About QAI – Quality & Accreditation Institute

Quality and Accreditation Institute (QAI) is an International Accreditation Body that provides Accreditation/ Certification to Healthcare Organisations (Hospitals, Clinics, Dental centres, Eye Clinics, Imaging centres, IVF centres, Dialysis centres, Home Care, Stroke centres, Telehealth services, Hair Transplant Centres, Bone Marrow Transplant centres, Rehabilitation centres, Ambulatory care centres etc.).

QAI provides a platform to stakeholders including professionals and organisations, associated with Quality in any way, to share their wisdom and Knowledge in order to make healthcare services delivering better outcomes.

QAI is closely working with stakeholders including Government agencies to support accredited healthcare facilities in terms of empanelment and other benefits.

Target Segment:

Any healthcare facility such as Hospitals, Clinics, Dental centres, Eye Clinics, Imaging centres, IVF centres, Dialysis centres, Home Care providers, Stroke centres, Telehealth services, Hair Transplant Clinics, Bone Marrow Transplant centres, Rehabilitation centres, Ambulatory care centres etc.).

Wellness Centres offering AYUSH Services

Applicants can be from Private or Government settings.

Eligibility Criteria:

  • Applicant must have implemented a Quality Management System/ Patient Safety Program/ any Certification or Accreditation Program for a minimum period of last 3 years continuously
  • QAI accredited healthcare facility will be given preference
  • Applicant can be from any part of India

Application Form Content:

  • To be filled in the format given
  • General Information about the Healthcare facility
  • Specific information about Quality Practices/ Certifications / Accreditation (Evidences to be submitted to support any such claims)
  • 2 case studies/ examples to demonstrate improvement/ patient safety in last 3 years
  • Language for submission – English

Application Fee:

  • Rs. 1180/- (including 18% GST) for each application

    To be payable to HOSPEX India’s account as shared below:

    Tritvam Integris Pvt. Ltd.
    GST No: 32AAJCT2250M1ZA
    Tritvam Integris, Jyothi Trade Centre, Chettupuzha, PO,  Thrissur – 680 012

Application Submission Date:
Last date for submitting applications: 10 August 2025.

Completed Application including payment proof to be mailed to:

Ms. Chandni Rohila

Accreditation Officer
Quality & Accreditation Institute (QAI)
709, Wave Silver Tower, Sector 18, Noida-201301, India
Ph. No.: +911206664981
M: +91 8287841146
Email – chandni@qai.org.in

Terms and Conditions:

  • Only completed applications will be taken up for evaluation.
  • Jury will comprise of experienced professionals with healthcare operations, management, quality, clinical background
  • Only one application per location is acceptable.
  • Applicants can save the completed application and all evidences on a google drive folder and can share the folder access link to QAI through email to chandni@qai.org.in.
  • Applications submitted after the last date will not be entertained.
  • Jury will evaluate the applications and decide on the winners of the Award.
  • Shortlisted applicants may be called for virtual presentation, if needed.
  • Winners will be announced by 12 August 2025.
  • Winers will have to travel to Kochi (Cochin), to collect their Awards in an event to be held on 23 August 2025.
  • Organisers will not make any travel, stay arrangements and winners have to make their own arrangements.
  • Decision of the Jury shall be final and binding on all.

Source: https://hospex.in/

Industry Update – Sustainability in Healthcare by ISQua Education

ISQua Education was created in order to foster a global community of learning and improvement in healthcare quality and safety.

ISQua has partnered with the International Hospital Federation’s Geneva Sustainability Centre and The Centre for Sustainable Healthcare to offer a new introductory course on sustainability in healthcare.

This 6-module course, available with any ISQua Fellowship subscription, explores the healthcare sector’s role in climate change, sustainable quality improvement, and practical steps to reduce waste.

Learn from global case studies and gain tools to drive change within your organization.

🏅 Bonus: The first 100 Fellows to complete the course get a free 3-month subscription to GSC’s Carbon Emissions Learning Lab.

📩 To know more, please visit : fellowship@isqua.org | www.isqua.org/education

Source: https://www.isqua.org/education

Industry Updates : Import of refurbished medical devices are not allowed – CDSCO

Central Drugs Standard Control Organisation (CDSCO) regulates Quality, Safety and Performance of the Medical Devices under Drugs and Cosmetics Act, 1940 and Medical Devices Rules 2017.


To control the second-hand / unregulated medical devices in the country, recently CDSCO has issued a letter to the Principal Commissioner of Customs, New Delhi, clarifying that No separate license is issued for import of refurbished medical devices in the country. Following points are covered in the communication

  1. All the Medical Devices are regulated under Medical Devices Rules 2017
  2. However, there is no specific provision for regulation of refurbished medical devices under the said Medical Devices Rules 2017         
  3. Hence no license is issued for import of such devices and it cannot be imported in the country under Medical Devices Rules 2017 for sale and distribution.

Industry Update – Standard IVD Evalution protocols

Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly issued the Draft Standard IVD Evaluation Protocols

The document outlines the need for standardized evaluation protocols for IVDs as mandated by the Medical Devices Rules 2017. These protocols are essential to ensure the quality and performance of diagnostic kits used in India

Several specific performance evaluation protocols have been drafted, including those for:

a. Chikungunya IgM ELISA
b. Dengue NS1 RDT and ELISA
c. Zika virus real-time PCR , among others

The document includes detailed guidelines for evaluating various IVDs, emphasizing:

i. Study design and ethical considerations
ii.Requirements for evaluation sites and laboratory standards
iii.Procedures for conducting diagnostic accuracy studies
iv.Acceptance criteria for sensitivity and specificity of tests.

This initiative by ICMR and CDSCO aims to enhance the reliability of diagnostic testing in India through structured evaluation processes, ensuring that manufacturers adhere to high standards of quality in their products. Stakeholder engagement is critical to refining these protocols before their final adoption.

Stakeholders are invited to provide comments on these protocols until February 15, 2025.

Comments should be submitted via email before 15th February 2025, at ivdevaluation@gmail.com as per the specified format given in the notification

Source: https://www.icmr.gov.in/icmrobject/uploads/WhatsNew/1735801120_advt_ivd_document.pdf

Industry Update – Second National Essential Diagnostics List – Draft

Draft of Second edition of “National Essential Diagnostics List” for public comment is released by Indian Council of Medical Research (ICMR), New Delhi

Public comments are invited on or before 15/1/2025 via email to mail id icmr.nedl2@gmail.com

Appreciating the urgent need to improve the availability of quality diagnostics at all levels of healthcare facilities in the country, Indian Council of Medical Research has drafted the second edition of National Essential Diagnostics List (NEDL).

The list has been drafted in consultations with all the relevant stakeholders for all levels of health care.

The comments/views on the draft may be forwarded via email at icmr.nedl2@gmail.com on or before 15/l/2025

Source: https://www.icmr.gov.in/icmrobject/uploads/Static/1735745135_draftsecondeditionnedl.pdf

Industry Update – Lab management Program

The Laboratory Management program targets middle to senior professionals in government institutions, private hospitals, and corporate laboratories.

It aims to equip participants with the knowledge and skills needed to manage and lead laboratories effectively while enabling them to pursue higher education.

Recognizing that 80% of patient care depends on diagnostic tests and analyses, the program focuses on developing competent leaders who can ensure laboratory quality, operational efficiency, and regulatory compliance, ultimately enhancing patient care and informed decision-making

Key Objectives of the program :

Leadership and Quality Excellence:
Develop leadership skills while ensuring compliance with international quality standards to enhance laboratory performance and patient care.

Technology and Innovation:
Leverage cutting-edge technologies, including Laboratory Information Systems (LIS) and artificial intelligence (AI), to modernize operations and improve diagnostic accuracy.

Financial and Risk Management:
Build expertise in financial planning and risk management to maintain sustainable and resilient laboratory operations.

Research and Clinical Competency:
Strengthen capabilities in research, clinical trials, and data management, fostering innovation and evidence-based decision-making.

Business Growth and Marketing:
Gain marketing and business development skills to expand laboratory services and succeed in competitive healthcare markets.

Who Should Attend ?

a. Laboratory Managers and Supervisors
b. Pathologists and Laboratory Technicians
c. Quality Assurance and Compliance Officers
d. Biotechnologists and Research
e. Scientists
f. Pharmaceutical and Clinical Trial
g. Professionals
h. Sales and Marketing Professionals in Diagnostics
i. Biomedical Engineers and Technologists
j. Corporate Laboratory Executives
k. Academicians and Trainers in Laboratory

Program Dates & Venue

The programme will start on Monday, March 24, 2025, and will conclude on Wednesday, March 26, 2025.

The programme will be held at IIHMR University, 1, Prabhu Dayal Marg, Sanganer Airport, Jaipur – 302 029.

The University campus provides a learning environment for the participants, who are welcome to use the library and recreational facilities at the campus

Program Fee :

The programme fee for Indian participants is Rs.30,000 plus GST (18% as applicable), and for international participants it is USD 355 plus GST (18% as applicable).

The programme fee covers tuition, background reading material, lodging, and boarding

Certificate of Participation:

A certificate of participation on completion of the programme will be issued by IIHMR University, Jaipur

Program Coordinators:

Kirti Agarwal
Manager-Strategic Planning and Partnership
IIHMR University, Jaipur

Puneet Sethi
COO and Co-Founder
BIO HUBB (A Unit Of Biopreseve Innovations LLP)

Registrations:

Please send your nominations/registrations to the following address

Programme Officer (Training)
IIHMR University
1, Prabhu Dayal Marg, Sanganer Airport,
Jaipur-302029, Rajasthan, India

Phone – +91-141-3924700
Email – training@iihmr.edu.in
Mobile – +91 9358790012

Source: https://iihmr.edu.in/

Industry Update – “MEDTECH QUALITY CHAMPION AWARDS”

MEDTECH QUALITY CHAMPION AWARDS is announced by Andhra Pradesh Medical Technology Zone (AMTZ) in collaboration with CII-Institute of Quality to facilitate organisations in the area of Quality, Innovation and Excellence.

The awards have four categories to encourage Quality initiatives with Med tech industries to meet the goal of achieve Atmanirbharta and achieve the goal of Government of India towards “Viksit Bharat-2047”.

About the Award

The MedTech Quality Champion Award recognizes and honors medical device organizations that demonstrate exceptional innovation, quality, and commitment to advancing healthcare through their products and services. This initiative not only aims to celebrate achievements but also to inspire a culture of excellence, driving organizations toward higher standards of quality and innovation.

Categories of Awards

The awards are divided into four categories:

  1. Micro and Small-Scale Enterprises
  2. Medium Enterprises
  3. Large-Scale Enterprises
  4. Service Sector Organizations

Eligibility Criteria

– Must be a legal entity in India with a minimum establishment of 2 years.
– Demonstrated a case study with application of Quality Tools & methodologies
– Relevant work completed within the last 2 years

Application Timelines

Last date for receipt of Application – 13th November 2024
Presentation by Companies – 19th to 21st November 2024
Award announcement – 27th November 2024

Visit www.cii-iq.in to download the application form and email to nidhi.barve@cii.in and karthik.v@amtz.in to submit your registrations

Award Presentation

Winners will be recognized at the CII Excellence Summit on 27 – 28 November 2024, attended by industry leaders and experts, fostering a spirit of collaboration and innovation in the MedTech sector.

Contact Details:

Nidhi Barve
Counsellor – Institute of Quality
nidhi.barve@cii.in
+91-9967950770

Karthik Raj V
Scientist B, AMTZ
karthik.v@amtz.in
+91-96771 63469

Source:
https://cii-iq.in/
https://www.amtz.in/

Industry update

Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) is awarded provisional approval from the Quality Council of India (QCI) to function as a certification body for the ICMED 9000 (ISO 9001 requirements plus additional requirements specified under the scheme) and ICMED 13485 (ISO 13485 requirements plus additional requirements specified under the scheme) certification schemes.

This accreditation will enable IPC-MvPI to assess the quality management systems of medical device industries, ultimately enhancing the quality of medical devices and ensuring consumer protection

To know more, please visit https://ipc.gov.in/news-highlights/1296-indian-pharmacopoeia-commission-%E2%80%93-materiovigilance-programme-of-india-ipc-mvpi-as-certification-body-for-icmed-9000-and-icmed-13485.html

Source: https://www.ipc.gov.in/icmed-certification.html