The Ministry of Textiles introduced the Medical Textiles (Quality Control) Amendment Order 2025, on 1st January 2025 which came into force on the date of its publication in the Official Gazette.
This order requires that Medical Textiles must comply with their respective Indian Standards. The products must display the Standard Mark under a license from the Bureau of Indian Standards, under Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018.
The following products are covered under the Medical Textiles (Quality Control) Amendment Order-
Sr. No. | Product | Indian Standard |
1 | Sanitary napkins | IS 5405: 2019 |
2 | Disposable baby diaper | IS 17509: 2021 |
3 | Reusable Sanitary pad/ Sanitary Napkin/ Period Panties | IS 17514: 2021 |
4 | Shoe covers | IS 17349: 2020 |
5 | Dental Bib or Napkins | IS 17354: 2020 |
6 | Bed sheet and Pillow Cover | IS 17630: 2021 |
Notice for BIS-Certified and Applicant Manufacturers
Manufacturers certified by the Bureau of Indian Standards (BIS) or those who have applied for certification for products listed under Schedule A of the Principal Order are allowed to sell or display their old stock products without the BIS mark under certain conditions.
Conditions:
- The products must have been manufactured or imported prior to the implementation timeline of this Order.
- A declaration must be made as per sub-section (4) of Section 18 of the BIS Act, 2016 (11 of 2016).
Important Deadline:
- Declared old stock can be sold or displayed until 30th June 2025.
Manufacturers are advised to ensure compliance by declaring their eligible stock within the specified timeframe.
Timeline for Implementation:
- For Large and Medium Enterprises: 1st January 2025.
- For Small and Micro Enterprises: 1st April 2025.
For detailed information, access the official notification from here: Medical Textiles (Quality Control) Amendment Order
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