In a significant development for the Indian medical device manufacturing industry, the Ministry of Steel has announced that it will issue No-Objection Certificates (NOCs) on a case-to-case basis for the import of special grades of stainless steel used in producing critical healthcare equipment.

This decision, reported by The Economic Times (09 August 2025), is expected to provide immediate relief to manufacturers of surgical blades, stainless steel needles, endoscopic devices, and other precision instruments who rely on these niche steel grades for production.

Why This BIS Exemption Matters

Earlier this year, the Ministry of Steel mandated that raw materials, including special grades of steel, must comply with Bureau of Indian Standards (BIS) certification before being sold in India. While the policy aimed to ensure quality and safety, it created challenges for medical device manufacturers because:

• These special steel grades are not widely produced in India due to their limited demand.
• Import restrictions risked supply chain disruptions in critical healthcare products.
• Manufacturers feared production delays for essential medical and surgical tools.

By allowing NOCs for these imports, the Ministry has ensured that India will not face shortages of vital surgical instruments and diagnostic tools, safeguarding both healthcare delivery and the medical manufacturing sector.

Industry Welcomes the Move

The Association of Indian Medical Device Industry (AiMeD) and leading manufacturers have praised the Ministry for addressing the industry’s concerns with speed and empathy.

“We are thankful to the government for being responsive and understanding of the medical device sector’s needs,” said Rajiv Nath, Forum Coordinator of AiMeD.

Industry experts also highlighted that this decision is critical to avoid potential supply chain crises, especially for products in the pharma and healthcare sectors.

Next Steps – Building Local Capacity

While the exemption addresses immediate challenges, the Ministry of Steel is also working with the Steel Authority of India (SAIL) to develop indigenous production capabilities for these special low-volume stainless steel grades. This long-term solution will:

• Reduce dependency on imports.
• Strengthen India’s position as a global hub for medical device manufacturing.
• Support the government’s “Make in India” initiative.

Appreciation for a Timely Decision

We applaud the Ministry of Steel for its proactive and collaborative approach. This move not only supports medical device manufacturers but also ensures uninterrupted patient care across India.

Tagging all medical device manufacturers, especially those in the stainless steel surgical tools, pharma-grade steel components, and healthcare equipment sector, to acknowledge and support this positive step forward.

Contact GYE LLP, your trusted BIS consultancy service provider in India.

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