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India Launches National Registry for Medical Implants
India is establishing a national registry for all implantable medical devices, a significant move to enhance patient safety and market accountability. This system will track both devices and the patients receiving them. The goal is to curb the overuse of implants and ensure only high-quality, certified devices enter the market. A senior government official stated that the proposal is under high-level review and an announcement is expected soon. The registry's data will inform policy and government health scheme procurement, helping distinguish between quality and lower-cost options while preventing substandard imports.
Market Growth and Import Reliance Addressed
India's medical device market, currently valued at $15 billion, is projected to reach $50 billion by 2030. Despite this growth, the country imports over a million high-risk implants annually, including cardiac stents, orthopedic joints, and pacemakers. The registry is part of the National Medical Devices Policy 2023, which aims to regulate the expanding market by tackling regulatory inconsistencies, import dependence, high costs, and oversight gaps. This initiative is crucial for managing the sector's growth, especially after adverse events linked to certain implants.
Phased Rollout and Industry Input
Initially, the registry will focus on cardiac and orthopedic implants, collecting data from manufacturers, suppliers, and hospitals. It will then expand to cover all medical devices. Industry leaders, such as Rajiv Nath from the Association of Indian Medical Devices Industry, highlight the registry's importance for tracking implants, aiding patient identification in recalls, monitoring safety, and generating evidence for accountability. The Medical Devices Rules, 2017, have already improved oversight by classifying devices by risk and requiring quality management systems, aligning India with international standards.
Supporting Domestic Manufacturing and Global Goals
The registry supports government initiatives like 'Make in India' and the Production-Linked Incentive (PLI) scheme, aimed at boosting domestic manufacturing and reducing reliance on imports. While India's medical device exports were about $3.8 billion in 2023-24, imports were $8.2 billion, showing a continued need for imported advanced devices. The National Medical Devices Policy 2023 aims to make India a global manufacturing hub, targeting a 10-12% share of the global market within 25 years and growing the domestic sector to $50 billion by 2030. The registry is a key step in ensuring quality, safety, and traceability in India's MedTech sector.