Steel Certification Rule Sparks Alarm Across Medical Device Industry

India’s medical device industry is preparing for major disruptions after the Ministry of Steel issued a new mandate requiring Bureau of Indian Standards (BIS) certification of all raw materials used in finished and semi-finished steel products.

This came as a surprise to manufacturers reliant on imported stainless steel components. Previously, the policy only applied to finished steel imports. The sudden policy change has left manufacturers confused over how to respond.

"This is a low volume material hence making the BIS certification process is not feasible both economically and operationally. We have therefore requested the ministry of steel for exemption of the BIS requirement for the import," said Rajiv Nath, MD, HMD.

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Medical device manufacturing is concerned the new directive will end availability of medical products ranging from surgical blades, needles, endoscopes, and other precision devices. Most of these products rely on niche stainless steel materials, including small quantities of items like steel capillary tubes, strips, and specialty pipes - items that are all imported internationally and in low-volume.

Industry associations are raising concerns over the dangers of this. reached out to the ministry formally, requesting to be excluded on low volume imports. Unless this is resolved immediately, stakeholders will need to respond to the potential for either lengthened production timelines or increased costs, failure to comply will ultimately impact supply chains in India’s health-care system.

"Despite efforts to source stainless-steel strip from local manufacturers such as Tata Steel, Jindal, BSL, Anil Metal, Stelco, and Mecon Limited, the required specification for manufacturing SS capillary tubing is not available in India as it is not sustainable or economical to produce small batches of tubing," the letter said.