Process for obtaining BIS License under Medical Textiles (Quality Control) Order, 2023
Medical textile products such as sanitary pads, child diapers, recyclable sanitary pad/ feminine napkins/ period panties, dental bib/ paper napkins, bedsheet, cushion cover, and shoe covers have actually been regulated for top quality in India by the Medical Textiles (Quality Control) Order, 2023 (the “Order”). The Order requires all producers and importers of clinical fabric items to classify the products with the Indian Standard (IS) Mark. A license over the IS Mark is issued by Bureau of Indian Standards (BIS) after it has actually determined that the clinical textiles and the manufacturing procedure meet with the standards recommended by BIS. Such permit is commonly described as the BIS certificate.
Which are the standards suggested by BIS that clinical textiles have to satisfy?
The medical textiles covered by the Order have to mandatorily meet with the standards described in the table below.
Exactly how to acquire certificate to make use of Indian Standard mark on medical fabrics?
The procedure to get permit over the Indian Standard (IS) mark is described in Scheme– I of Schedule– II to the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018 (the “Conformity Assessment Regulations”). The procedure involves on-site factory evaluation, testimonial of producing process, sampling/testing of items at BIS acknowledged laboratories, and rigorous adherence to recommended labelling and marking requirements.
Do all suppliers and importers of medical textiles need affirmation of Indian Standard (IS) mark on tag?
Yes, the Order applies to all manufacturers (Indian and international) of clinical fabrics who desire to market clinical fabrics in India. Therefore, such manufacturers will certainly need to obtain permit over IS mark from BIS.
Nevertheless, the Order does not put on:
The above-mentioned goods/articles require not be mandatorily labelled with IS Mark.
a.) Goods/articles planned for export, or
b.) Sanitary paper napkin, baby diaper, recyclable sanitary napkin/ sanitary napkins/ period panties made by Self Help Groups (SHG).
What are the timelines for the Order to end up being effective?
All manufacturers (domestic and international) of dental bib/ napkins, bedsheet, cushion cover, and footwear covers need to make sure that any of their items sold in India on or after April 1, 2024, should include an IS Mark on their tag.
All suppliers (residential and international) of sanitary pads, child diapers, multiple-use sanitary pad/ sanitary pads/ duration panties need to make sure that any of their items offered in India on or after October 1, 2024, should have an IS Mark on their tag.
Final thought:
It usually takes around 4– 6 months, depending on the hold-up caused in replying to inquiries raised (if any type of), arranging inspection( s), sample deposition, and clearance of cost dues, and so on, to receive certificate over IS Mark from BIS. For that reason, manufacturers and importers of clinical textiles ought to make sure that they make the permit application in time to ensure that the business does not endure.
