Medical Textiles (Quality Control) Second Amendment Order, 2025 - Detailed Information

To ensure safety and quality in the healthcare sector, the Minister of Textiles has, in consultation with the Bureau of Indian Standards (BIS), issued the Medical Textiles (Quality Control) Second Amendment Order, 2025, by notification S.O. 3526(E). 
The amendment directly affects the production, certification, and sale of medical textile products in India, furthering the commitment to ensure globally acceptable quality standards in healthcare in the country.

Medical Textiles Quality Control Order

The BIS QCO for Medical Textiles 2024 was issued on 23rd October 2024 under the BIS Act, requiring certain medical textile products to meet the requirements for BIS certification before sale, distribution, and import into India.
The order has since been extended by this Second Amendment Order dated 1st January, 2025.

Key Highlights of MEDICAL TEXTILES Extension Order

Below, we have mentioned the key highlights from the recent QCO. Go through them to get complete information:

Extended Sale Period for Old Stock:

The recent amendment is aimed at providing relief to manufacturers and importers with old stock that they already own.

The government has now extended the date for the sale of non-certified old stock:

“Where any manufacturer certified by the Bureau, or any manufacturer who has applied to the Bureau for certification... declares, before the date specified in Schedule A that their old stock, manufactured or imported before such date, did not bear the Standards Mark, such manufacturer or importer shall be permitted to sell, display, or offer for sale the declared stock up to 31 December 2025.” 

This amendment replaces the previous wording in Paragraph 2 of the principal Order.

Effective Date:

• The Second Amendment Order came into effect immediately upon publication in the Official Gazette (August 2025).
• The extended sale period for uncertified old stock is valid until December 31, 2025.

What Products Are Covered under MEDICAL TEXTILES?

The regulation impacts all items in Schedule A to the original Medical Textiles (Quality Control) Order, 2024, including (but not limited to):

All of the products listed, if newly produced or imported after the effective date, must meet the BIS Standard Mark and have to be compliant with any applicable Indian Standards (IS codes).

Implications for Manufacturers and Importers

ERCS Pvt Ltd wishes to remind stakeholders in the medical textiles industry of the following:

1. Inventory Declaration: Declare any unsold old stock manufactured or imported before the compliance date.

2. BIS Certification: Please certify your product(s) and/or apply for certification without delay.

3. Labelling: There will only be BIS Standard Mark products for sale (except unsold old stock, which has a grace period).

4. Compliance Deadline: No listed item will be enforced after December 31, 2025.

Conclusion

The Medical Textiles (Quality Control) Second Amendment Order, 2025, provides clarity and spacing for manufacturers during the difficult transitional period to mandatory BIS Certification India. The compliance grace period ends on December 31, 2025, and products will not be sold in Indian markets if listed and are found non-compliant.