The COVID-19 pandemic reshaped how the world views
respiratory care. Devices such as ventilators, oxygen concentrators, CPAP/BiPAP
machines, and nebulizers became lifelines during the crisis—and in India, they
quickly moved into the spotlight of regulators. Under the Central Drugs
Standard Control Organization (CDSCO), respiratory devices now face some of the
strictest oversight, making respiratory device registration in India a highly
regulated pathway compared to other categories.
This heightened attention means manufacturers and importers
must understand the nuances of CDSCO medical device rules and how they apply
specifically to respiratory technologies.
Key Regulatory Focus Areas
1. Risk-Based Classification
Most respiratory devices are considered high-risk due to
their direct impact on critical patient functions. Under MDR 2017 India, many
of these products fall into Class C or Class D, requiring stricter compliance,
deeper scrutiny, and closer review during CDSCO approval.
2. Import & Licensing Scrutiny
For overseas manufacturers, CDSCO expects not only an import
license but also supporting evidence such as a Free Sale Certificate (FSC) and
adherence to BIS compliance standards. The process for securing an oxygen
concentrator license or ventilator compliance in India is therefore much more
stringent than for low-risk devices.
3. Testing & Safety Standards
Respiratory devices must align with recognised international
standards like IS/IEC 60601 for electrical safety and ISO 14971 for risk
management. While the testing procedures are rigorous, manufacturers should
note that demonstrating conformity to these standards is non-negotiable for
CDSCO.
4. Software in Respiratory Devices
Modern respiratory devices are increasingly software-driven.
Under Rule 11 of MDR 2017, software that influences clinical decisions or
directly impacts therapy falls into higher risk categories, triggering
additional compliance requirements.
5. Post-Market Surveillance Obligations
Even after CDSCO approval, manufacturers must remain
vigilant. Robust post-market surveillance and vigilance reporting mechanisms
are mandatory to ensure continued patient safety and regulatory compliance in
India.
What This Means for Manufacturers
For medical device companies eyeing the Indian market, these
requirements translate into a regulatory landscape that is both complex and
unforgiving. Each step—whether securing an import license, proving safety
compliance, or managing vigilance systems—demands precision and foresight.
This is why many manufacturers and importers choose to
partner with experienced regulatory consultants. Navigating Indian medical
device regulations without expert guidance often leads to delays, queries, or
outright rejections.
Partner with Titans Medical Consulting
At Titans Medical Consulting, we specialize in helping
medical device manufacturers and importers streamline their CDSCO approval
journey. From interpreting MDR 2017 India requirements to aligning with
post-market obligations, our team ensures your respiratory devices meet every
compliance expectation efficiently.
Conclusion
Respiratory devices face stricter regulatory scrutiny in
India than most other categories. This stems from their public health
significance and the lessons learned during the COVID-19 pandemic. Staying
compliant under CDSCO medical device rules requires proactive planning,
accurate documentation, and regulatory expertise.
If your organization is exploring respiratory device
registration in India, now is the time to take action. Connect with Titans
Medical Consulting for tailored guidance that helps you bring safe, compliant,
and trusted respiratory devices to the Indian market.
Sources
Central Drugs
Standard Control Organization (CDSCO)
Ministry of
Health and Family Welfare, Government of India
Medical Device Rules, 2017 (as amended) – Gazette of India