Medical device quality and safety have been the top priority for India’s medical device regulatory authorities. Given the impact of medical devices on healthcare, quality of their raw materials has to be strictly regulated as well. Hence, the Indian Ministry of Textiles has announced the enforcement of the quality control order for medical textiles. This is a major step towards ensuring the quality and safety of medical textile products, thereby safeguarding public health. The order establishes strict quality benchmarks for essential medical textile products. Sanitary napkins, baby diapers, reusable sanitary pads, and dental bibs are some of the medical textile products covered by this order. By implementing measures for quality control for medical textiles, the government has taken a significant step towards protecting patient safety.

Quality control for medical textiles: Government introduces new order

The government has issued a new order outlining guidelines for regulating the quality of medical textiles. The medical textiles products listed in the specified schedules must abide by the relevant Indian Standards. Additionally, they must bear the Standard Mark issued by the Bureau of Indian Standards (BIS). Non-compliance with the new order for medical textiles can lead to fines and penalties.

Products covered by the new order

The new quality control order covers a range of essential medical textile products. We have listed some of them

• Baby diapers
• Bed sheets and pillow covers
• Sanitary napkins
• Reusable sanitary pads/ Sanitary Napkin or Period Panties
• Dental bibs/napkins
• Shoe covers

These products will have to meet the criteria defined in the new order. The priority of this medical textiles quality control order is product safety and environmental sustainability. Furthermore, special attention has been given to regulating phthalate levels in baby diapers owing to associated health risks. Moreover, the notified standards outline essential performance metrics, such as biodegradability, hygiene tests, biocompatibility assessments, pH levels, and bacterial and fungal bioburden. Notably, the BIS and the Textiles Committee have been entrusted with responsibility of certifying and enforcing compliance of medical textiles with the standards.

Exemption from quality control order for medical textiles

Sanitary napkins, baby diapers, reusable sanitary pads, sanitary napkin, and period panties manufactured by self-help groups have been exempted from the mandatory Standard Mark requirement.

Pharmadocx Consultants: Your ally for easily marketing medical devices in India

With the implementation of the Medical Textiles (Quality Control) Order, sanitary napkin, baby diaper, and dental bib manufacturers and importers will be required to secure the BIS certification. As per the latest order providing guidelines on quality control for medical textiles, specified medical textile products will have to abide by strict BIS guidelines. Thus, securing BIS certification will be a vital requirement for marketing these medical textile products. We at Pharmadocx Consultants provide dedicated BIS certification services. Our team will help you meet product specifications, quality benchmarks, and testing requirements mentioned in BIS and regulatory guidelines. We provide tailored support to our clients to help them secure all necessary certifications in a hassle-free manner. Email at [email protected] or call/Whatsapp on 9996859227, to let us help you easily launch your medical textile products in India.