Quality Control Order for Medical Textiles
In a major step toward improving public health and safety, the Indian Ministry of Textiles has announced the enforcement of the Medical Textiles (Quality Control) Order, 2023, which will take effect on October 1, 2024. This order establishes strict quality standards for essential medical textile products, including sanitary napkins, baby diapers, reusable sanitary pads, and dental bibs.
The initiative focuses on ensuring product safety and environmental sustainability, with particular attention to regulating phthalate levels in baby diapers due to associated health risks. The notified standards (IS 5404:2019 for sanitary napkins and IS 17509:2021 for disposable baby diapers) outline essential performance metrics, such as pH levels, hygiene tests, bacterial and fungal bioburden, biocompatibility assessments, and biodegradability.
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The Quality Control Order (QCO) requires these products to meet defined criteria, with non-compliance potentially resulting in fines or other penalties. However, Self-Help Groups (SHGs) and small-scale enterprises are exempt from these regulations.
Once the order is in force, manufacturers, importers, and retailers must secure a Bureau of Indian Standards (BIS) license, reinforcing the government’s commitment to safeguarding consumer interests.
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About Operon Strategist
Operon Strategist, a leading medical device regulatory consulting company, is dedicated to assisting medical device manufacturers and importers in obtaining the Bureau of Indian Standards (BIS) license, a crucial requirement for compliance with Indian regulations. With the implementation of the Medical Textiles (Quality Control) Order, 2023, manufacturers and importers of essential products like sanitary napkins, baby diapers, and dental bibs are now required to adhere to stringent quality standards, making BIS certification essential for market entry.
At Operon Strategist, we provide expert guidance throughout the entire BIS licensing process, helping clients easily navigate the regulatory landscape. Our team of specialists offers tailored support, ensuring all product specifications, quality benchmarks, and testing requirements are met to secure the necessary certification efficiently and without hassle. By partnering with us, you can focus on your core business while we handle the complexities of regulatory compliance, helping you bring safe and high-quality products to market with confidence.
