The Bureau of Indian Standards (BIS) is India’s national regulatory body ensuring product safety, quality, and reliability. BIS certification is mandatory for certain medical devices and helps manufacturers gain consumer trust, comply with Indian regulations, and facilitate market entry. The certification process involves rigorous testing, factory inspections, and ongoing surveillance to maintain compliance with Indian standards (IS guidelines). BIS operates through multiple regional and branch laboratories across India, ensuring stringent quality control.

Accorpmed provides end-to-end support for BIS certification, including application filing, factory inspection readiness, compliance documentation, and liaising with regulatory authorities to streamline approval.