Urgent BIS Notification: Implementation of Medical Textiles (Quality Control) Amendment Order, 2024

Introduction to the BIS QCO Notification

An amendment order called Medical Textiles (Quality Control) Amendment Order, 2024 has been issued by the Government of India, under the more recent Bureau of Indian Standards Act, 2016. Earlier, the Medical Textiles (Quality Control) Order, 2023 mandated BIS certification for specified medical textile products such as sanitary napkins, diapers, shoe covers, and hospital bed linen, with item-wise implementation timelines prescribed under Schedule-A and Schedule-B.

Now, the Government of India has issued the Medical Textiles (Quality Control) Amendment Order, 2024 under the Bureau of Indian Standards Act, 2016. This amendment revises the implementation provisions of the 2023 Order by extending the compliance timelines, in the public interest, after consultation with the Bureau of Indian Standards.

Products covered in this notification

The notification applies to all Medical textile products that were subject to the Medical Textiles (Quality Control) Order, 2023. 

The coverage includes: 

• Surgical masks, gowns, and drapes
• Medical textile products that can be disposed of or are non-disposable
• Any other products that were mentioned in Schedule A and Schedule B of the original order

Key Provisions of the Order

• The amendment replaces sub-paragraph (2) of paragraph 1 in the initial 2023 Order:
• This order will have effect as shown in column (5) of the SCHEDULE - A and SCHEDULE - B attached to this Order.
• Schedule-A (Column (5) (Implementation Date)) is changed to 1 st October 2024.
• The rest of the provisions of the Medical Textiles (Quality Control) Order, 2023, will stay unaltered.

What is the Date of Implementation?

Date of Implementation: 01 October 2024

Now, What to Do?

The manufacturers, importers, and licensees of the medical textile products will have to attend to their compliance requirements under the amended QCO and ensure that all the products comply with the BIS standards by 01 October 2024.

Brand Liaison support can help in achieving timely compliance by:

• Communicating new implementation deadlines to all teams
• Coordinating testing and certification of medical textile products
• Managing documentation and submission for BIS approval
• Monitoring compliance progress to meet the 01 October 2024 deadline
• Reducing risks of non-compliance, errors, or regulatory penalties

Engaging with Brand Liaison can ensure accurate, timely, and hassle-free compliance with the Medical Textiles (Quality Control) Amendment Order, 2024.