Medical Technology Association of India - MTaI

04/12/2025

A key regulatory shift for India’s MedTech sector.

The government has introduced a single, harmonised labelling standard under MDR 2017, streamlining compliance and eliminating overlaps with Legal Metrology requirements.

* Principal Display Panel declarations are no longer mandatory for medical devices
* One clear framework = reduced overlapping compliance burden and greater regulatory clarity

This change supports Ease of Doing Business while maintaining robust consumer safeguards.



Ministry of Health and Family Welfare, Government of India | NITI Aayog | Department of Pharmaceuticals | Indian Council of Medical Research | Pavan Choudary

03/12/2025

The Department of Consumer Affairs has clarified that medical device labelling will now be governed exclusively under the Medical Device Rules, 2017. This move establishes a single, unified regulatory framework and removes earlier overlaps with Legal Metrology labelling requirements.

We appreciate the Department of Consumer Affairs, CDSCO, and the Department of Pharmaceuticals for taking cognizance of industry concerns and implementing this important reform. It will significantly advance ease of doing business for the MedTech sector in India

Read the full news: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2183777®=3&lang=2



Department of Consumer Affairs, Government of India | Press Information Bureau - PIB, Government of India | Legal Metrology India | Ministry of Health and Family Welfare, Government of India | NITI Aayog | Indian Council of Medical Research | Pavan Choudary

Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution, has noti

03/12/2025

Medical technology is a powerful force for inclusion. Assistive Products (APs) from smart wheelchairs and bionic limbs to voice-controlled interfaces are essential tools that help overcome barriers, enabling independence, dignity, and full participation.

Yet, access to these innovations remains inequitable. Estimates suggest that in many lower-income settings, only about 1 in 10 people who need APs can access them. This is not a technology gap alone- it is a systems gap.

To unlock the full potential of MedTech for global equity, we must act together:

- Innovate for scale: Fund R&D for low-cost, adaptable, and user-centered design solutions.
• Bridge policy to access: Build procurement, financing, and distribution pathways that make APs available, reliable, and equitable worldwide.

MedTech innovation must be guided by a deliberate commitment to inclusion. Let’s shape systems where every person who needs assistive technology can access it easily, affordably, and with dignity



Ministry of Health and Family Welfare, Government of India | Ministry of Social Justice and Empowerment, Government of India | The Global Fund | World Institute on Disability | Pavan Choudary | Indian Council of Medical Research

01/12/2025

As digital health apps and AI-powered tools proliferate across the healthcare landscape, the need for robust standards governing validated medical claims has become urgent.

In a recent feature by The Hindu BusinessLine, MTaI Chairman Mr. Pavan Choudary highlighted a pressing priority for India: tackling the spread of unverified health claims made by digital platforms and ensuring that health information delivered through apps and AI systems meets established standards of accuracy and evidence.

India's draft guidance for SaMD and SiMD represents a pivotal step toward building a trustworthy digital health ecosystem. The implementation of rigorous regulatory frameworks governing medical claims will be essential not only for safeguarding patient wellbeing, but also for fostering responsible and sustainable innovation in the digital health sector.

Read the full Article: https://www.thehindubusinessline.com/specials/pulse/when-a-software-is-your-medical-device/article70335970.ece



Ministry of Health and Family Welfare, Government of India | NITI Aayog | Department of Pharmaceuticals | Indian Council of Medical Research | Pavan Choudary | | | The Hindu Business Line

01/12/2025

MedTech innovation has fundamentally reshaped HIV care, offering solutions from rapid diagnostics to effective long-acting PrEP and ART.

But innovation doesn't have an impact unless it reaches everyone. Funding gaps, inequity, and weak implementation still block access. To bridge the gap we must:

- Prioritize Investment in next-generation prevention, cure, and development (R&D).
- Fix systems and policies that limit access, Amplify Awareness: U=U (Undetectable = Untransmittable).
- Let’s move breakthroughs from labs to communities so no one is left behind.



Bureau of Indian Standards | Pavan Choudary | The Global Fund | IAS - International AIDS Society | Indian Medical Association | World Health Organization (WHO)

28/11/2025

Highlights from MTaI’s Regulatory Affairs Committee Meeting | November 27, 2025

MTaI’s RA Committee convened on November 27, 2025 to discuss key regulatory priorities and chart the way forward for India’s MedTech sector.

The discussions focused on key regulatory developments and emerging challenges shaping the MedTech landscape. The session also reinforced MTaI’s continued commitment to collaborating with regulators and contributing to the evolution of a robust, forward-looking regulatory framework for medical technology in India.



Bureau of Indian Standards | Government e Marketplace GeM | Pavan Choudary | Narendra Modi | PMO India

27/11/2025

A clinical challenge sparked a MedTech revolution.

In 1816, French physician René Laennec faced diagnostic limits, so he improvised with a rolled sheet of paper. That moment led to the invention of the stethoscope: medicine’s first true diagnostic device or as some say the first Medical Device.

From Laennec’s monaural wooden tube to today’s digital, AI-enabled stethoscopes, this innovation has evolved but its purpose endures: enabling precision, improving patient outcomes, and advancing clinical insight.



Indian Medical Association | World Health Organization (WHO) | Bureau of Indian Standards | Government e Marketplace GeM | Pavan Choudary

24/11/2025

Pacemakers are no longer just about keeping the heart beating they’re about keeping it in sync with life.

Depending on clinical need, doctors choose from single-chamber, dual-chamber, or biventricular devices and now even leadless pacemakers, which sit directly inside the heart. Advanced rate-responsive systems further personalize pacing, adjusting in real time to match a person’s activity level.

Why it matters:
Stability: Instantly corrects irregular heart rhythms.
Adaptability: Aligns your heart rate with your daily pace.
Longevity: Enhances quality of life through reliable innovation.

Technology and care, working in perfect Rhythm.



Indian Medical Association | World Health Organization (WHO) | Bureau of Indian Standards | Government e Marketplace GeM | Pavan Choudary |

19/11/2025

COPD (chronic obstructive pulmonary disease) is a group of progressive lung diseases, including chronic bronchitis and emphysema, that cause breathing difficulties due to airflow limitation.

Often undetected until advanced, COPD is now being tackled with innovative MedTech solutions:
· Early detection with spirometers
· Better daily management via digital inhalers & portable nebulizers
· Continuous monitoring using pulse oximeters and remote patient monitoring systems to reduce flare-ups

Persistent breathlessness is not normal. Consult your doctor and learn more about COPD today.



Indian Medical Association | World Health Organization (WHO) | Bureau of Indian Standards | Government e Marketplace GeM | Pavan Choudary

15/11/2025

As National Newborn Care Week (November 15-21) begins, we reaffirm our shared responsibility to give every newborn the healthiest possible start in life.

The theme “Safety, Quality, and Nurturing Care: Birth Right of Every Newborn” underscores the importance of resilient health systems, skilled healthcare professionals, and access to safe, reliable medical technologies from the very first moments of care.
Across India, advancements in neonatal care are transforming outcomes:

Safety: Modern ventilators and monitoring systems provide critical life support for premature and high-risk newborns.
Quality: Precision diagnostics and screening tools enable early detection and timely intervention for vulnerable infants.
Nurturing Care: Radiant warmers, neonatal resuscitation units, incubators, thermal management, feeding technologies, and other intensive care solutions ensure stability and growth during the crucial early days of life.

Behind every healthy beginning stand healthcare professionals whose expertise, compassion, and commitment make these innovations truly meaningful from nurses and doctors to biomedical engineers and technicians.

Together, let’s ensure that safety, quality, and nurturing care remain the birthright of every newborn



Indian Medical Association | World Health Organization (WHO) | Bureau of Indian Standards | Government e Marketplace GeM | Pavan Choudary

12/11/2025

From Generic to Personal: The MedTech Turning Point

Advancement in genomics, connected diagnostics, and intelligent data analytics are redefining care delivery transforming medicine from standardized protocols to truly individualized interventions.

But progress depends on more than innovation. It requires readiness across the health ecosystem, data integrity, interoperability, forward‑looking regulation, and value‑driven reimbursement. Without these, the promise of precision care remains out of reach.

As India’s MedTech landscape matures, the challenge is no longer about possibility but pace: How quickly and inclusively can personalized medicine become everyday reality?

We’d love to hear your perspective: What do you view as the most critical enabler or barrier for bringing personalized care into everyday practice?



Indian Medical Association | World Health Organization (WHO) | Bureau of Indian Standards | Government e Marketplace GeM| Pavan Choudary

10/11/2025

Today on , we honor vaccines as a landmark public health triumph saving millions worldwide. Each shot is more than medicine- it protects communities across generations.

This success is powered by medical technology: from precision-engineered syringes minimizing waste and contamination, to robust cold chain systems preserving vaccine potency in challenging environments. Smart monitoring and data platforms further ensure vaccines reach every corner safely and effectively.

Choose protection. Empower health. Build resilient communities.



Indian Medical Association | World Health Organization (WHO) | Bureau of Indian Standards | GEM - Government E Marketplace | Pavan Choudary