Medical textile products, including sanitary napkins, baby diapers, reusable sanitary pads, sanitary napkins, period panties, dental bibs, napkins, bedsheets, pillow covers, and shoe covers, are subject to quality regulation in India in accordance with the Medical Textiles (Quality Control) Order, 2023. The Order requires all manufacturers and importers of these products to label them with the Indian Standard (IS) Mark. The Bureau of Indian Standards (BIS) issues an IS Mark license after confirming that medical textiles and their manufacturing processes conform to the prescribed BIS standards.. This license is commonly known as the BIS license.

Medical Textiles (Quality Control) Order, 2023:

On September 27, 2023, the Ministry of Textiles initially introduced the Medical Textiles (Quality Control) Order, 2023, which set forth comprehensive guidelines to ensure the quality and safety of various medical textile products. The order required manufacturers to conform to specified Indian Standards and bear the Standard Mark under a license from BIS. The compliance dates varied for different products, with most required to meet standards by April 1, 2024.

Key Compliance Deadlines and Requirements:

How to Obtain a License for the Indian Standard Mark on Medical Textiles?

To obtain a license to use the Indian Standard (IS) mark on medical textiles, manufacturers must follow the process outlined in the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018, specifically detailed in Scheme – I of Schedule – II. This process includes an on-site factory inspection, a review of the manufacturing process, sampling and testing of products at BIS-recognized labs, and strict adherence to prescribed labeling and marking requirements. All manufacturers and importers of medical textiles, whether Indian or foreign, who wish to sell their products in India must declare the Indian Standard (IS) mark on their labels. Therefore, these manufacturers need to obtain a license for the IS mark from BIS.

However, the Order does not apply to:

1. Goods/articles intended for export, or

2. Sanitary napkins, baby diapers, reusable sanitary pads, sanitary napkins, and period panties produced by Self Help Groups (SHGs) do not need to be mandatorily labeled with the IS Mark.

Latest Amendment:

The latest notification, issued on February 22, 2024, extends the compliance deadline for all medical textile products to October 1, 2024. The Medical Textiles (Quality Control) Amendment Order, 2024, becomes effective on the date of its publication in the Official Gazette.

Implications:

This extension provides manufacturers with an additional six months to ensure their products meet the required BIS standards. The Ministry’s decision reflects its consideration of the challenges faced by manufacturers in achieving compliance within the original timeframe.

Conclusion

The Ministry of Textiles’ extension gives manufacturers more time to meet high standards for medical textiles, enhancing quality and safety. Securing a BIS IS Mark license takes 4 to 6 months, with possible delays from queries, inspections, sample deposition, and fee clearance. To avoid disruptions, timely application is essential. For expert guidance on navigating these regulatory changes and ensuring compliance, consult Morulaa, a leading consultancy specializing in CDSCO regulatory approvals and medical device registrations in India. Visit Morulaa for expert guidance and support in meeting these new regulatory requirements.