𝐒 𝐉 𝐄𝐗𝐈𝐌 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬

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Dated: 26.03.2025

Mandatory BIS Standard on Medical Textiles through Quality Control Order

The Ministry of Textiles, Government of India, recently introduced the Medical Textiles (Quality Control) Amendment Order, 2025. This crucial amendment, effective from January 1, 2025, aims to enhance quality standards in medical textiles, aligning Indian products with international benchmarks for quality and safety.

Key Highlights of the Amendment Order:

1. Extended Timeframe for Existing Stock:

Manufacturers who have already received certification or have applied for certification from the Bureau of Indian Standards (BIS) are permitted to sell or display their pre-existing stock—products manufactured or imported without a BIS mark before the implementation date—up to June 30, 2025. This provides businesses sufficient time to transition smoothly to new standards without significant economic disruption.

2. Updated Implementation Timelines:

The amendment distinguishes between enterprise sizes to ensure compliance is feasible:

• Large and Medium Enterprises: Mandatory compliance from January 1, 2025.
• Small and Micro Enterprises: Extended compliance period until April 1, 2025, offering these enterprises additional time to meet quality standards.

3. Supporting MSME Sector:

The amendment reflects sensitivity towards the operational realities faced by small businesses. Definitions of enterprise sizes follow the Micro, Small, and Medium Enterprises Development Act, 2006, ensuring clarity and fairness in the application of these regulations.

Why This Matters:

Medical textiles play an essential role in healthcare safety, including products like surgical gowns, masks, drapes, and sterilization wraps. Ensuring the quality and safety of these textiles is paramount for protecting healthcare workers and patients. This amendment is expected to improve product reliability significantly, fostering confidence among healthcare providers and enhancing India’s competitiveness in global markets.

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Source: Ministry of Textiles

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