Page 3 - Medical Devices

India's medtech industry goes local to develop high-end equipment

According to the Department of Pharmaceuticals' annual report for 2024-25, India imported medical devices worth $8.1 billion, while exports stood at $3.7 billion in the financial year 2023-24 (FY24)

Indian medical devices industry calls USA's 27% tariff challenge for growth

The new tariffs may impact India's medical devices exports, said Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AiMeD)

USTR flags hurdles for US med device exports to India before tariff move

Medtech manufacturers' groups expect negotiations may lead to fairer outcomes for both sides

USTR flags barriers for med device export to India ahead of Apr 2 deadline

Move comes even as domestic medtech manufacturers lobby asked GOI to work towards a fair deal

Licensing delays pushing medical device makers abroad: Parliament panel

Implementation of tracking system, independent advisory board, lateral entry among panel's recommendations to remove CDSCO's perception of licence raj

Zydus Lifesciences to buy 86% stake in Amplitude Surgical for Rs 2,430 cr

Zydus will file a mandatory cash tender offer for the remaining shares of Amplitude at the same purchase price of €6.25 per share

Govt asks IVD kit makers to report adverse events; aims to collate info

Releases draft format for adverse events for rapid identification and rectification of potential device failures

IMQ Group sets up JV in India to test medical devices, electrical products

European conformity assessment firm says it will bring in 'rigorous quality and safety standards'

CDSCO to disallow import of pre-owned, refurbished med devices into India

Health Ministry to constitute expert committee, import suspended until policy framework is finalised

Medtech industry expects regulatory body to reclassify more medical devices

CDSCO to initiate workshops; industry says step will bring regulatory uniformity

Parliamentary panel highlights gaps in medical radiation device testing

A parliamentary committee on Monday raised serious concerns about the country's capability to test and regulate radiation-emitting medical devices, urging immediate reforms in the national testing infrastructure. The Standing Committee on Consumer Affairs, Food and Public Distribution revealed significant gaps in the testing framework for critical medical equipment like X-ray and MRI machines in its fifth report submitted to Parliament. The National Testing House (NTH) currently lacks the expertise and capacity to comprehensively test and certify radiation-emitting medical devices, despite existing regulatory oversight from the Atomic Energy Regulatory Board (AERB) and the Central Drugs Standard Control Organization (CDSCO). The committee recommended establishing a collaborative framework between NTH, AERB, and CDSCO to address the identified regulatory shortcomings. Key recommendations include developing specialised testing capabilities at NTH, investing in advanced testing ...

CDMO player OneSource expands GLP-1 drug-device capacity as demand soars

OneSource Specialty Pharma recently raised Rs 801 crore through equity issuance

Dr Morepen launches weight management product, forays into wellness biz

Company eyes Rs 30 crore revenue in first year, Rs 200 crore by 2030

CII body calls for expansion of PLI for medical devices to more products

CII's medtech group to ask govt for strict policy on import of refurbished devices, incentives in R&D, and enhanced rebate on export duties

BIS to prioritise development of standards for 214 critical medical devices

The Bureau of Indian Standards (BIS) on Monday said it is prioritising development of standards for 214 critical medical devices, which are set for phased completion by December 2025. These devices, which include septal closure devices, plasma sterilizers, and phototherapy machines, are in line with the National Medical Device Policy, 2023 and have been identified in consultation with Department of Pharmaceuticals. BIS, in a statement, said the national standards body is developing standards for innovative products such as therapeutic footwear, portable ramps, braille displays, and fall detectors, which support individuals with disabilities. BIS has published over 1,700 standards for the medical sector, covering specialities such as cardiology, neurology, orthopaedics, ophthalmology, and more. Of these, around 1,200 standards specifically focus on medical devices critical to healthcare. BIS standards in this sector ensure that Indian medical devices are safe, effective, and globall

Demand for super top-up health insurance plans rises after Covid pandemic

A super top-up health insurance plan pays the policyholder for medical expenses that exceed the coverage limit of their base health insurance policy

Govt launches Rs 500 crore scheme to strengthen medical devices industry

This initial outlay of Rs 500 crore will be for three years, up to financial year 2026-27 (FY27), according to a government communication

Medical device makers claim import of refurbished devices can harm industry

Manufacturing associations added that recent government orders permitting such imports threaten the efforts of Indian manufacturers to meet the vision of Aatmanirbhar Bharat

CDSCO flags 4 drugs as spurious and 48 as not of standard quality

The apex drug regulatory body also listed 48 drugs and formulations, manufactured by 40 companies, as not of standard quality (NSQ)

Glucometer maker Morepen Labs to hive off medical devices business

Expanding capacities, backward integrating production and eyeing US market for exports