Representative image (AI-generated) NEW DELHI: Medical devices used every day—from syringes and surgical sutures to implants—may soon face tighter regulation, with Centre proposing stricter labelling rules and a standardised testing fee system aimed at improving safety and accountability. Under a draft amendment to Medical Devices Rules, 2017, manufacturers may be required to clearly disclose on product labels where devices are sterilised, including licence number of the facility. The move is intended to improve traceability so that authorities can quickly identify the source in case of infection or device failure. Govt has also proposed fixing testing charges across categories. As per the draft, implantation tests could cost Rs 5,000, sterility tests, Rs 2,000 and surgical sutures, Rs 3,000. These charges will rise by 5% annually, while fees for tests not listed will be decided by authorised laboratories. Officials say the changes are aimed at bringing uniformity in testing and strengthening oversight in the fastgrowing medical devices sector, where regulation has often been flagged as uneven. The industry, however, has raised concerns over feasibility and cost implications. Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, said that while the proposals are a step towards strengthening quality systems, they may need to be fine-tuned for smooth implementation. “The testing fees may not fully reflect actual lab costs, and if fixed without consulting NABL-accredited labs, it could make testing difficult to sustain, leading to delays. This may increase compliance costs and put some pressure on supply and prices, especially for high-volume items like syringes and consumables,” he said. “A riskbased approach, with stricter checks for high-risk devices, would be more effective. The sterilisation labelling requirement also needs review as it may delay exports by 3-4 weeks…,” the forum coordinator added.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideosCong, TMC, DMK Guilty’, PM Modi Blasts Oppn For Blocking Women Reservation BillIndia Summons Iran Envoy Summoned After Ships Targeted In Strait of Hormuz | WatchWomen’s Reservation Amendment Fails In Lok Sabha, Delimitation Bill Put On HoldYogi Adityanath Alleges ‘Identity Crisis’ In Bengal, Targets TMC Over GovernanceBJP Leaders Protest Outside Rahul’s Residence Over Women Quota Bill; Hema Malini, Bansuri Lead10th Indian Vessel Crosses Strait Of Hormuz Since Conflict Began”Women Were Being Used” Tharoor Backs Women’s Reservation, Warns On Delimitation Issue: “You’re Firing… After Clearance!” India-Flagged Ship’s Last Words Before Hormuz TurnbackNation Awaits PM Modi’s Address As Women Bill Fails And Hormuz Crisis Escalates‘Not A Failure Of The Government’: Why Rijiju Is Blaming The Opposition For Women’s Bill Defeat123PhotostoriesAkshaya Tritiya 2026: Why these foods are considered auspicious and bring good fortune and prosperity5 watches rich men with old money wear6 healthy leaves you should add to your daily dietAkshaya Tritiya 2026: Buy these 5 things for good fortune5 grand palaces that are now world-famous museums7 factors driving real estate growth in India’s non-metro cities7 foods in your kitchen that actually came from PersiaAlia-Ranbir to Saif-Kareena: 5 celebrity weddings that completely rewrote the Indian shaadi style rulebook’The Devil Wears Prada 2′ to ‘The Odyssey,’ and more: Hollywood’s biggest 2026 Summer releases10 iconic biryani varieties in India you probably haven’t tried yet123Hot PicksIran warDelimitation Bill DefeatPurple cap winnerOrange cap winnerIPL Points TablePublic holidays April 2026Bank Holidays AprilTop TrendingIPL Orange Cap 2026VijayPM Modi LiveWorld Largest EconomySue BirdIce SpicePahalgam Pony Wallah StoryWomen Quota BillE Coli Smuggling CaseErika Kirk Event

Representative image (AI-generated)  NEW DELHI: Medical devices used every day—from syringes and surgical sutures to implants—may soon face tighter regulation, with Centre proposing stricter labelling rules and a standardised testing fee system aimed at improving safety and accountability. Under a draft amendment to Medical Devices Rules, 2017, manufacturers may be required to clearly disclose on product labels where devices are sterilised, including licence number of the facility. The move is intended to improve traceability so that authorities can quickly identify the source in case of infection or device failure. Govt has also proposed fixing testing charges across categories. As per the draft, implantation tests could cost Rs 5,000, sterility tests, Rs 2,000 and surgical sutures, Rs 3,000. These charges will rise by 5% annually, while fees for tests not listed will be decided by authorised laboratories. Officials say the changes are aimed at bringing uniformity in testing and strengthening oversight in the fastgrowing medical devices sector, where regulation has often been flagged as uneven. The industry, however, has raised concerns over feasibility and cost implications. Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, said that while the proposals are a step towards strengthening quality systems, they may need to be fine-tuned for smooth implementation. “The testing fees may not fully reflect actual lab costs, and if fixed without consulting NABL-accredited labs, it could make testing difficult to sustain, leading to delays. This may increase compliance costs and put some pressure on supply and prices, especially for high-volume items like syringes and consumables,” he said. “A riskbased approach, with stricter checks for high-risk devices, would be more effective. The sterilisation labelling requirement also needs review as it may delay exports by 3-4 weeks…,” the forum coordinator added.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideosCong, TMC, DMK Guilty’, PM Modi Blasts Oppn For Blocking Women Reservation BillIndia Summons Iran Envoy Summoned After Ships Targeted In Strait of Hormuz | WatchWomen’s Reservation Amendment Fails In Lok Sabha, Delimitation Bill Put On HoldYogi Adityanath Alleges ‘Identity Crisis’ In Bengal, Targets TMC Over GovernanceBJP Leaders Protest Outside Rahul’s Residence Over Women Quota Bill; Hema Malini, Bansuri Lead10th Indian Vessel Crosses Strait Of Hormuz Since Conflict Began”Women Were Being Used” Tharoor Backs Women’s Reservation, Warns On Delimitation Issue: “You’re Firing… After Clearance!” India-Flagged Ship’s Last Words Before Hormuz TurnbackNation Awaits PM Modi’s Address As Women Bill Fails And Hormuz Crisis Escalates‘Not A Failure Of The Government’: Why Rijiju Is Blaming The Opposition For Women’s Bill Defeat123PhotostoriesAkshaya Tritiya 2026: Why these foods are considered auspicious and bring good fortune and prosperity5 watches rich men with old money wear6 healthy leaves you should add to your daily dietAkshaya Tritiya 2026: Buy these 5 things for good fortune5 grand palaces that are now world-famous museums7 factors driving real estate growth in India’s non-metro cities7 foods in your kitchen that actually came from PersiaAlia-Ranbir to Saif-Kareena: 5 celebrity weddings that completely rewrote the Indian shaadi style rulebook’The Devil Wears Prada 2′ to ‘The Odyssey,’ and more: Hollywood’s biggest 2026 Summer releases10 iconic biryani varieties in India you probably haven’t tried yet123Hot PicksIran warDelimitation Bill DefeatPurple cap winnerOrange cap winnerIPL Points TablePublic holidays April 2026Bank Holidays AprilTop TrendingIPL Orange Cap 2026VijayPM Modi LiveWorld Largest EconomySue BirdIce SpicePahalgam Pony Wallah StoryWomen Quota BillE Coli Smuggling CaseErika Kirk Event


Daily use medical devices to see stricter checks
Representative image (AI-generated)

NEW DELHI: Medical devices used every day—from syringes and surgical sutures to implants—may soon face tighter regulation, with Centre proposing stricter labelling rules and a standardised testing fee system aimed at improving safety and accountability. Under a draft amendment to Medical Devices Rules, 2017, manufacturers may be required to clearly disclose on product labels where devices are sterilised, including licence number of the facility. The move is intended to improve traceability so that authorities can quickly identify the source in case of infection or device failure. Govt has also proposed fixing testing charges across categories. As per the draft, implantation tests could cost Rs 5,000, sterility tests, Rs 2,000 and surgical sutures, Rs 3,000. These charges will rise by 5% annually, while fees for tests not listed will be decided by authorised laboratories. Officials say the changes are aimed at bringing uniformity in testing and strengthening oversight in the fastgrowing medical devices sector, where regulation has often been flagged as uneven. The industry, however, has raised concerns over feasibility and cost implications. Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry, said that while the proposals are a step towards strengthening quality systems, they may need to be fine-tuned for smooth implementation. “The testing fees may not fully reflect actual lab costs, and if fixed without consulting NABL-accredited labs, it could make testing difficult to sustain, leading to delays. This may increase compliance costs and put some pressure on supply and prices, especially for high-volume items like syringes and consumables,” he said. “A riskbased approach, with stricter checks for high-risk devices, would be more effective. The sterilisation labelling requirement also needs review as it may delay exports by 3-4 weeks…,” the forum coordinator added.



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