CDSCO brings updated guidance on med device software
The 76-page draft outlines updated guidance on different types of software, applicable standards, quality management systems, and licensing authorities. However, in a statement, MTaI voiced that the final document should provide ‘greater clarity on evaluation protocols for AI/ML-based medical devices.
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MTaI Applauds CDSCO’s Draft Guidance On Medical Device Software
The Medical Technology Association of India (MTaI) welcomes CDSCO’s draft framework for medical device software, calling it a key step toward digital health innovation.
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GST Reforms To Make Healthcare, Insurance More Affordable: Experts
GST Council slashes tax on cancer drugs, insurance, devices, and nutrition, boosting affordability, easing patient costs, and promoting preventive care; experts call it a milestone in healthcare reform.
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Drug, device makers should follow market entry pricing for marketing samples: Govt
According to a circular by the Department of Pharmaceuticals, under the UCPMP disclosure, free evaluation samples distributed to healthcare professionals should be valued on the same price charged to the stockist or immediate customer on a per unit basis.
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Pharma Inc hopes for fair deal as Donald Trump announces 25% tariffs
Trump on Wednesday called India's tariffs on US exports among the highest in the world, with the most strenuous non-monetary trade barriers of any country, in a post on Truth Social
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Govt panel starts drafting rules for refurbished medical device imports
A high-level inter-departmental committee has begun discussions on regulating refurbished medical devices, balancing patient safety concerns with affordable healthcare access
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"MNCs push to restart refurbished med device imports; seeks entry in repair initiative "
The Medical Technology Association of India (MTaI) has urged to reinstate imports with the approvals from the DGHS and the Ministry of Environment; the body has also sought inclusion of medical devices in the ERSO initiative to advance their repair in the country.
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Medical devices industry raises concerns over additional 25% US tariff
With US duties on Indian medical devices now at 50%, industry groups warn of trade instability, lost competitiveness, and adverse impact on American patients
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Committed to fair, balanced deal, says India after Trump announces 25% tariffs
India is committed to a trade deal with the US by autumn 2025, despite Trump's 25% tariffs, emphasizing the broader economic relationship beyond goods.
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