Government Introduces New Medical Textiles (Quality Control) Order, 2024

The Government of India has introduced the Medical Textiles (Quality Control) Order, 2024, to ensure the quality and safety of medical textiles products. This order supersedes the Medical Textiles (Quality Control) Order, 2023. The new order was published on October 23, 2024.

The order states that Medical textiles products listed in the specified schedules must conform to the relevant Indian Standards and bear the Standard Mark issued by the Bureau of Indian Standards (BIS).

Products Covered

The regulations cover a range of medical textile products, including:

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

The BIS and the Textiles Committee will be responsible for certifying and enforcing compliance with the standards.

Exemptions

The regulations exempt sanitary napkins, baby diapers and reusable sanitary pads/ sanitary napkin or period panties manufactured by self-help groups from the mandatory Standard Mark requirement. Additionally, they also exempt any goods or article meant for export from this requirement.

Timeline for Implementation

All manufacturers of sanitary napkins, baby diapers and reusable sanitary pads/ sanitary napkin or period panties must comply with this order by January 1, 2025. Furthermore, manufacturers of shoe covers, dental bibs/napkins, bed sheets and pillow covers must comply with this order by April 1, 2024.

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