BIS certification is no longer just a regulatory formality. For manufacturers and importers of medical electronics in India, it is a legal necessity. From ventilators to defibrillators, medical electrical equipment must now comply with Indian safety standards under the IS 13450/IEC 60601 series and carry the BIS Standard Mark to be legally marketed.
In this guide, we’ll explain why BIS certification matters, which devices are covered, the compliance process, and how Astute Labs supports you at every step.
Devices Requiring BIS Certification
Device Type | BIS Standard |
Ventilator (Critical Care) | IS 13450-2-12 / ISO 80601-2-12 |
Defibrillator | IS 13450-2-4 |
Infusion Pump / Syringe Pump | IS 13450-2-24 |
Patient Monitor (ICU) | IS 13450-2-27 |
Infant Warmer | IS 13450-2-21 |
BP Monitor (Home Use) | IS 13450-1-11 |
More devices will be added under QCOs, so it’s important to stay updated on regulatory changes.
How Astute Labs Helps You Get BIS Certified
Astute Labs, accredited by NABL, CDSCO, BIS, and QAI, brings 15+ years of experience and over 100,000 tested devices. Our support includes:
- Turnkey testing: EMI/EMC testing and software validation
Our goal is to help clients avoid repeat audits and accelerate time to market. Learn how we streamline pre-compliance EMC testing to reduce delays.
Conclusion: BIS Isn’t Just a Label, It’s a Business Enabler
Achieving BIS certification gives you more than just legal approval. It establishes product credibility, reduces customs risk, and makes your devices eligible for institutional tenders. By working with a trusted partner like Astute Labs, you simplify your pathway to market and safeguard your brand reputation.
Want to get started? Book a BIS Compliance Consultation
