In a transformative move that promises to reshape India's medical device landscape, the Central Drugs Standard Control Organisation (CDSCO) has unveiled a groundbreaking self-certification model for low to moderate-risk equipment. This strategic shift marks a significant departure from the traditionally cumbersome licensing process that has long burdened manufacturers.
What This Means for Medical Device Manufacturers
The new framework introduces a risk-based classification system where manufacturers of Class A and B medical devices can now bypass the lengthy licensing procedure. Instead, they can self-certify their products' safety and quality standards, dramatically reducing the time-to-market for essential medical equipment.
This regulatory overhaul addresses one of the industry's most persistent challenges: bureaucratic delays that often stretched for months, hampering innovation and increasing costs for both manufacturers and ultimately, healthcare consumers.
Boosting Make in India Initiative
The timing of this reform couldn't be more strategic. By streamlining the regulatory pathway, the government aims to achieve multiple objectives simultaneously:
- Accelerate domestic manufacturing of medical devices
- Reduce import dependency currently estimated at over 70%
- Attract foreign investment in the MedTech sector
- Enhance global competitiveness of Indian medical device companies
Risk-Based Approach Ensures Patient Safety
While simplifying procedures for low-risk devices, the CDSCO maintains rigorous oversight for higher-risk categories. Class C and D devices, which include life-support equipment and implantable devices, will continue to undergo comprehensive scrutiny through the established licensing route.
This balanced approach ensures that patient safety remains paramount while eliminating unnecessary regulatory hurdles for simpler devices like surgical gloves, thermometers, and blood pressure monitoring equipment.
Expected Impact on Healthcare Ecosystem
Industry experts predict this reform will trigger several positive outcomes:
- Faster innovation cycles for Indian MedTech startups
- Reduced costs for medical devices through increased competition
- Improved healthcare accessibility across tier 2 and 3 cities
- Job creation in medical device manufacturing sector
The new system represents a significant step toward realizing India's ambition of becoming a global MedTech hub while strengthening the country's healthcare infrastructure against future challenges.
