Government Finalizes Plans for ₹1 Lakh Crore Private Sector R and D Fund The Indian government is set to launch a ₹1 lakh crore fund aimed at boosting research and development (R and D) in the private sector, as announced by Economic Affairs Secretary Ajay Seth on Thursday. The initiative, focused on enhancing R and […]
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An Overview: Medical devices play a crucial role in modern healthcare, ensuring effective diagnosis and treatment. However, before a medical device can be imported and marketed in India, it must comply with the regulations laid out by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017. One of the primary requirements
An Overview: For medical devices, a well-rounded strategy goes far beyond simply achieving regulatory approval or obtaining a European CE mark. A successful lifecycle strategy focuses on aligning each stage of the device’s development and use—from concept to post-market surveillance (PMS)—around a central guiding principle: meeting the intended purpose. By defining and continuously verifying this
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Indian MedTech Gains US Edge as Trump Cuts Costs and Shifts Supply Chains With Donald Trump back in the White House, his administration is expected to reshape Indian MedTech and pharmaceutical ties with the United States. Known for his business-oriented leadership style, Trump is anticipated to emphasize cost-reduction strategies. Recently, the US raised tariffs on
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Introduction to Conformity Assessment Procedures for Medical Devices Entering the European medical device market requires meeting strict regulatory standards, most notably through obtaining the CE mark. A critical part of this process is the conformity assessment procedure, outlined by the European Medical Device Regulation (EU) 2017/745 (MDR). This regulation ensures that medical devices placed on
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India’s Medical Device Sector to Benefit From Rs 500 Crore Government Scheme The Indian Government has unveiled a groundbreaking Rs 500 crore scheme aimed at strengthening the Medical Device Industry. This initiative seeks to support various critical areas of the MedTech sector, including the manufacturing of key components and accessories, skill development, clinical studies, and
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Overview of QMS Documentation to Meet ISO 13485 In the medical device industry, compliance with ISO 13485:2016 is essential for organizations aiming to meet global quality standards and ensure device safety and effectiveness. A well-structured Quality Management System (QMS) not only demonstrates regulatory compliance but also builds trust with customers and stakeholders. Achieving compliance with
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FICCI HEAL 2024: NITI Aayog Calls for Stronger State-Private Healthcare Collaboration The two-day FICCI HEAL 2024 conference concluded on Wednesday with a strong focus on State-Private Sector Collaboration for Better Healthcare in India. Centered around the theme ‘Swasth Bharat, Viksit Bharat,’ the event brought together healthcare leaders, policymakers, and innovators dedicated to building a healthier
PM Modi Inaugurates 5 PLI Projects Prime Minister Narendra Modi inaugurated and laid the foundation for multiple healthcare and pharmaceutical initiatives on Dhanvantari Jayanti and the 9th Ayurveda Day at the All India Institute of Ayurveda (AIIA), New Delhi. The event, attended by Union Minister for Health and Family Welfare J.P. Nadda and State Minister
Understanding GSPR Compliance for EU MDR Approval Navigating the complexities of General Safety and Performance Requirements (GSPR) compliance is crucial for medical device manufacturers aiming for EU MDR approval. GSPR ensures that each device meets essential safety and performance standards. However, creating clear, compliant documentation can be overwhelming. With an organized approach and attention to
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