Mandatory BIS Certification for Medical Textile Products
The Bureau of Indian Standards (BIS), India’s national standards body functioning under the Ministry of Consumer Affairs, Food and Public Distribution, plays a crucial role in maintaining quality and safety across various industries. BIS administers numerous schemes, including Product Certification (ISI mark), Management Systems Certification, Hall Marking of Gold and Silver Jewellery/Artefacts, and Laboratory Services. These initiatives are designed to benefit the industry while ensuring consumer protection.
Also read our service page: BIS Certification for Medical Devices in India
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At a recent event, G. Bhavani, Scientist-F / Sr. Director & Head of the Chennai Branch Office, addressed attendees, including the Chief Guest and other dignitaries. She emphasized the importance of compliance with the Medical Textiles (Quality Control) Order, 2023, which requires manufacturers to obtain a license. Bhavani highlighted the necessity for timely initiation of the licensing process and for all stakeholders involved in manufacturing medical textiles to stay informed about relevant Indian standards. She stressed that effective communication and collaboration among stakeholders are essential to ensure that the standards are thorough, fair, and aligned with practical realities.
Meenakshi Ganesan, Scientist-G & Head of the Southern Regional Laboratory at BIS, detailed the broad spectrum of medical textiles, which include products such as surgical gowns, bandages, implants, sanitary napkins, baby diapers, shoe covers, hospital bed linens, pillow covers, and dental bibs. These textiles are crucial for protecting against infections in healthcare settings and for various other applications, underscoring their importance in patient care and hygiene management.
Prof. Dr. G. Thiruvengada Senthilkumar, Medical Superintendent at Omandurar Medical College Hospital, Chennai, praised BIS for its “Manak Manthan” series of discussion-programmes. These monthly events aim to launch new standards, share revisions and amendments, and circulate drafts to relevant stakeholders, including local manufacturers, trade bodies, government departments, regulatory agencies, and academic institutions.
D. Jeevanandam, Scientist-D, provided insights into BIS and its E-BIS system, while Dharmbeer, Scientist-D from the Textile Engineering Department at BIS-Delhi, presented on the new Medical Textiles (Quality Control) Order, 2023. This order, issued by the Ministry of Textiles, mandates compliance with specified Indian Standards (IS) and the acquisition of a license from BIS. The Quality Control Order (QCO) and BIS certification are vital for ensuring the safety and quality of medical textiles, which are integral to public health, as seen in government welfare initiatives like the distribution of sanitary pads to schoolgirls.
Role of Operon Strategist
In this context, Operon Strategist, a leading medical device regulatory consulting company, offers expert guidance and support for navigating the complexities of compliance and certification processes. Their services are designed to help manufacturers achieve and maintain adherence to regulatory standards, ensuring that products meet the required quality and safety benchmarks. By leveraging their expertise, companies can streamline their path to compliance and focus on delivering high-quality medical devices and textiles. For tailored support and to ensure your compliance needs are met, contact us today.
