Overview: Center to Reclassify Medical Devices
New Delhi: In a significant move towards ensuring regulatory uniformity in the medical device sector, the government plans to reclassify approximately 1,178 medical devices into four categories based on their risk profile, under the Medical Device Rule (MDR), 2017.
The Central Drugs Standards Control Organization (CDSCO) is revising the existing classification framework to include the following categories: interventional radiology (186 devices), radiology therapy (114 devices), oncology (75 devices), and a newly introduced category for Class A non-sterile and non-measuring devices, encompassing 803 devices. This initiative will streamline approvals, with state licensing authorities empowered to regulate devices within their specific categories.
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Driving Clarity and Growth in the Medical Device Industry
India’s medical device sector is a critical component of the healthcare ecosystem, contributing to the prevention, diagnosis, treatment, and management of various medical conditions. The sector, currently valued at $11 billion, is projected to grow to $50 billion by 2030.
Speaking on the classification, Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), highlighted that the updated list incorporates a risk-based approach in line with international standards. Feedback from industry stakeholders has been solicited to refine and finalize the list.
The updated classification will ensure regulatory clarity, foster harmonized standards, and facilitate the incorporation of technological advancements. This is essential as India looks to reduce its reliance on imports—currently 86%—and bolster domestic production.
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Role of Operon Strategist in the Transition
Operon Strategist plays a crucial role in facilitating the growth and compliance of the medical devices sector. With their expertise in regulatory consulting and business solutions, they assist manufacturers in navigating the complexities of the PLI Scheme Medical Device Sales and other industry requirements.
Services Provided by Operon Strategist:
- Medical Device Regulatory Services: Support with ISO 13485 certification, CE marking, and FDA compliance.
- Project Management Assistance: Guidance in setting up greenfield projects under the PLI scheme.
- Quality Assurance Consulting: Ensuring adherence to quality standards and regulatory frameworks.
- Business Strategy Development: Crafting strategies for market entry and scalability.
- Technical Documentation: Preparation of detailed reports and submissions for regulatory approval.
The PLI Scheme Medical Device Sales initiative, combined with strategic support from organizations like Operon Strategist, is propelling India’s medical device industry toward global excellence.
Industry Challenges and Opportunities
While India’s medical device sector has seen significant advancements, challenges persist. The industry remains capital-intensive, with a long gestation period and heavy reliance on imports for high-value devices. To address these gaps, the government launched a ₹500 crore initiative in 2024, aimed at strengthening domestic manufacturing capabilities, fostering innovation, and building common infrastructure.
Operon Strategists can also aid in leveraging these schemes by assisting businesses in accessing government incentives, streamlining clinical studies, and ensuring compliance with international quality standards, thereby driving growth in the domestic medical device sector.
This reclassification initiative marks a significant step in creating a robust, self-reliant, and innovation-driven medical device ecosystem in India, with stakeholders, including Operon Strategists, playing a critical role in shaping the future of healthcare.
