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AiMeD asks govt to extend date for implementation of BIS certification for stainless steel used for surgical instruments

Gireesh Babu, New Delhi
Wednesday, October 13, 2021, 08:00 Hrs  [IST]

The Association of Indian Medical Device Industry (AiMeD), the umbrella association of Indian manufacturers of medical devices, has sought the Department of Commerce to extend the timeline for implementation of Bureau of Indian Standards (BIS) certification for specific stainless steel used for surgical instruments for smooth imports of raw material imports, by six months.

AiMeD, in a letter to the joint secretary of department of commerce, said that the manufacturing of medical devices requires the industry to meet global quality parameters, especially for exports and to maintain the same quality over a long period of time with consistency. The manufacturers are using the best quality raw material, for instance, Swiss steel for surgical blades, as they have to keep the quality of the products intact.

“But if we are not allowed to import the required stated steel with our buyers’ needed specifications, then we will fall short on our commitments of delivery as well as a quality to our discerning buyers in USA and Europe and to India’s leading surgeons,” it said.

Implementation of QCO (Quality Control Order) 2020 for IS 7226 from August 15 is restricting exports from its members who need to import the required steel from overseas mills and now acting as an internal non tariff barrier not only to import, but also for exports.

“You are well aware of the AiMeD’s advocacy for Make in India of raw materials and components but it should not be coercive or at cost of our exports, but as a capability building exercise,” said the letter from Rajiv Nath, forum coordinator, AiMeD.

The ministry of steel has insisted for procurement of carbon steel from local manufacturers like Tata Steel, BSL, Anil Metal, Steico etc., but the steel with required specification to manufacture surgical blade is not available in India, specifically due to lack of aesthetics in surface finish and dimensional consistency. It is also not export worthy. Years of efforts from the medical devices manufacturers to become trusty partners in markets of USA, Germany and European Union etc., will go wasted if Indian products are rejected there.

The request to extend the deadline is also in the backdrop of the delays and challenges owing to the Covid-19 pandemic. The Association requested the Department of Commerce’s intervention with the ministry of steel for a six months extension in the date of enforcement of the said standard, in line with the extensions given to IS 7291 and 11947.

It has also detailed a case as a sample, where Switzerland-based Kaltband AG’s sales of steel to one of its member companies, Haryana-based Niraj Industries Pvt Ltd, which is into manufacturing and exports of high precision surgical blades, especially to the US. Similar challenges are there with other surgical blade manufacturers.

As per new rules, the BIS certification is mandatory for a few products while importing into India. While Kaltband has already applied for BIS certification and submitted all the documents for IS 7226, IS 11947 and IS 7291, the procedure is affected due to ongoing Covid-19 travel restrictions. The BIS confirmed that all compliance were in order, but insisted on an inspection by its official. Foreign visits from India are still restricted due to the ongoing Covid situation and it might take a while for the official inspection of the Swiss facility to enable BIS certification.

The Association also requested the government to consider virtual inspection of the Swiss factory premises, as being done by many certification bodies and issue the license to overseas manufacturers. An extension in the timeline of implementation of IS 7226 by six months, thus, would help the industry to import raw material and complete production of these essential and critical medical devices to cater the needs of the country also, it added.

 

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