Medical Textiles (Quality Control) Order, 2023

The Union Ministry of Textiles has introduced Quality Control Orders (QCOs) for six medical- textile products that will come into effect from April 1, 2024.

Medical textiles QCO encompass a range of products vital to healthcare and hygiene. The products covered under this QCO include Sanitary Napkins, Medical textiles -Shoe covers, Medical textiles -Dental bib/Napkins, Disposable baby diaper, Reusable sanitary pad/ sanitarynapkin/ period panties andMedical textiles -Bed sheet and pillow cover

In mass consumption items of Medical textiles like Sanitary Pads and baby diapers, self help groups are exempted from QCO while Micro and Small units are given relaxation for 1 year so as facilitate penetration without affecting availability.

The conformity assessment requirements specified in these QCOs are equally applicable to domestic manufacturers as well as foreign manufacturers who intend to export their products to India.

The Bureau of Indian Standards shall be the certifying and enforcing authority. All Medical Textiles shall bear the Standard Mark under a license from the Bureau of Indian Standards

Any person, who contravenes the provisions of this Order, shall be punishable in accordance with the provisions of the Bureau of Indian Standards Act, 2016. Products covered under the order are given below:

For the purposes of the Schedule – A and Schedule – B, it is clarified that the latest version of Indian Standards established and published by the Bureau of Indian Standards from time to time in accordance with the  provisions of clause (17) of section 2 of the Bureau of Indian Standards Act, 2016 (11 of 2016), shall apply from the date of such publication.

Source – https://texmin.gov.in/quality-control-orders-qco

Launch of Healthcare textiles processing facility certification Scheme

Healthcare Textiles Processing Facility Certification Scheme Launched in India

On the occasion of World Health Day on 7 April, the triple A partnership of AMTZ LTD, Association of Healthcare Providers – AHPI (India) and Association of Indian Medical Device Industry – Aimed India, launched Healthcare Textiles Processing Facility Certification Scheme (HTPFCS) to ensure the quality of healthcare textiles, including personal protective equipment (PPE), by certifying the facilities or laundries that process them for reuse

While the Covid-19 pandemic has highlighted the importance of healthcare textiles and PPE in protecting healthcare workers and patients from infection, the quality of these products depends not only on the materials used but also on the processing facilities where they are sterilized, cleaned, and packaged.

The Healthcare Textiles Processing Facility Certification Scheme will help ensure that these facilities meet international standards for quality and safety. It aligns with international standards and guidelines, including those of the World Health Organization (WHO) and the International Organization for Standardization (ISO).

Under the scheme, healthcare textiles processing facilities can apply for certification by undergoing a rigorous evaluation process that includes site visits, documentation reviews, and testing of samples.The certification will be valid for three years, after which the facility will need to undergo a recertification process.

The Certification would be carried out by independent third party certifying agencies to be accredited as per applicable international standard, ISO 17065, and approved by AMTZ to assure their competence, impartiality and consistent implementation of certification process.

The Healthcare Textiles Processing Facility Certification Scheme is open for applications from healthcare textiles processing facilities in India and abroad.

source:http://www.pharmabiz.com/NewsDetails.aspx?aid=157437&sid=1#:~:text=The%20Healthcare%20Textiles%20Processing%20Facility%20Certification%20Scheme%20is%20a%20welcome,of%20healthcare%20textiles%20and%20PPE.