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Medical Device Safety
Context:
The health ministry is setting up an expert committee to monitor medical devices for adverse effects and improve patient safety.
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- The committee will focus on monitoring, recording, and analysing the root causes of adverse events or risks associated with medical devices, including in-vitro diagnostics.
- Experts in fields such as cardiology, gastroenterology, gynaecology, neurology, and radiology are being sought for the committee.
Background
- Historical Context: The journey of medical device regulation in India began under the Drugs and Cosmetics Act, 1940. Initially, only a limited number of medical devices were regulated as ‘drugs’ under this Act. However, as medical technology advanced, the need for specific regulations for medical devices became evident.
- The Medical Devices Rules, 2017, marked a significant milestone, providing a dedicated regulatory framework for medical devices.
- Regulatory Framework: The Central Drugs Standard Control Organisation (CDSCO), operating under the Ministry of Health and Family Welfare, serves as the primary regulatory authority for medical devices in India.
- The CDSCO establishes and enforces standards that govern the manufacture, import, sale, and distribution of medical devices.
- The Central Licensing Authority (CLA) classifies medical devices and IVDMDs into four risk classes based on the device’s intended use, associated risks, and other parameters outlined in the IMD: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).
Medical Devices Overview
- Medical devices include electronic equipment, implants, consumables, disposables, surgical instruments, and in-vitro diagnostic reagents.
- These devices are crucial for medical diagnosis, patient safety, and life-saving systems.
- Devices such as X-ray machines are considered more prone to causing adverse effects.
Adverse Events and Monitoring
- The Indian Pharmacopoeia Commission (IPC) implements the Materiovigilance Programme of India (MvPI).
- Reports on adverse events are assessed by: MvPI team, Experts from NHSRC, SCTIMST, and CDSCO.
- Based on discussions, MvPI:
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- Issues recommendations to CDSCO.
- Sends safety alerts to Medical Device Adverse Event Monitoring Centres (MDMCs) and Adverse Drug Reactions Monitoring Centres (AMCs) across India.
Challenges in India’s Medical Device Sector
- India imports 80% of its medical devices.
- Of ₹44,000 crore spent on importing medical electronics, over 60% are pre-owned devices.
- Concerns with pre-owned imports:
- Lack of calibration facilities.
- No regulatory oversight on validation of accuracy.
- Potential adverse diagnostic consequences.
Future of India’s Medical Device Industry
- The domestic medtech market was $12 billion in 2023-24, expected to quadruple to $50 billion by 2030.
- The government has halted imports of refurbished medical devices, but patient safety regulations remain weak.
- Experts call for:
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- Stronger alignment with international safety standards.
- Enhanced certification & inspection processes.
- Better environmental practices.
- Stricter regulatory oversight to ensure quality assurance and patient safety.
