New Delhi, August 6, 2025 — In a relief to the medical-devices industry, the Centre has temporarily eased BIS compliance for certain steel inputs used to make surgical blades, scalpels, needles and other device components. Officials will now issue case-by-case no-objection certificates (NOCs) for importing specialised stainless-steel strips, tubes and wires that are not made in India at scale, according to people present at a review meeting in New Delhi.
Why the pause matters
In June, the steel ministry notified that raw materials such as hot-rolled steel and ingots for Indian buyers would require http://BIS certificationBIS certification. Device makers warned of supply disruptions because special-grade alloys for precision medical tools are low-volume, niche products and rarely produced domestically. The government’s temporary reprieve aims to avoid shortages while a longer fix is framed.
What changes now
States and companies can seek NOCs for specific consignments until revised guidance is issued. Foreign suppliers also get additional time to register with the Bureau of Indian Standards. Officials indicated that a formal clarification will follow shortly, aligning enforcement with on-ground availability of raw materials.
Industry response
Industry bodies welcomed the decision. Representatives said the government responded quickly to concerns about possible stock-outs of surgical blades and endoscopy components. They also urged a clear transition plan so hospitals are not forced into last-minute substitutions.
The road ahead
The steel ministry and BIS are reviewing package-wise options: wider recognition of equivalent international standards, faster testing pathways for low-volume grades, and time-bound approvals tied to local capacity building. The aim is to protect quality and patient safety while keeping theatres supplied.
Why it matters for patients
India performs millions of procedures each year that rely on precision steel parts. Even short disruptions can delay surgeries and raise costs. A measured, data-based compliance roadmap can secure quality without choking imports that have no viable local substitute—yet.
