The industry had sought an exemption through the Medical Device Technical Advisory Group (MDTAG) (representative image) NEW DELHI: Medical device manufacturers have raised concerns over a new government rule requiring companies to print the licence number of an outsourced sterilisation facility on device labels, saying it could add to compliance burden and delay exports.The health ministry, in a notification dated August 14, 2026, amended the Medical Devices Rules, 2017, requiring manufacturers that outsource sterilisation to a licensed facility to mention its licence number on the device label. The requirement will become mandatory six months after the notification.The Association of Indian Medical Device Industry (AiMeD) has opposed the move, saying manufacturers are already being asked to obtain “loan licences” for using external gamma radiation or ethylene oxide (EO) sterilisation facilities.AiMeD said manufacturers had sought an exemption through the Medical Device Technical Advisory Group (MDTAG), but the new labelling requirement has instead added another compliance burden.The association said the rule could affect export shipments, as manufacturers may not be able to switch to another sterilisation facility if the one named on the packaging has a backlog or is unavailable. It claimed this could delay shipments by two to three weeks, compared with about a week earlier.AiMeD also questioned the need to print the subcontractor’s details on the product, saying manufacturers remain responsible for quality and traceability, with batch-level records already allowing the sterilisation process to be tracked.Join conversationView All Comments →Share your thoughts in the commentsInsightfulAgreeDisagreeSkepticalConcerningPromisingWorth ReadingBig DevelopmentPost CommentBe respectful · TOI community guidelinesThe industry body has sought clarity on whether overseas manufacturers and their sterilisation facilities will also need Indian licences and whether the requirement will apply to their packaging.It has also sought clarity on how manufacturers should handle existing packaging stock before the new requirement takes effect.The notification provides a six-month transition period and was issued after the government considered objections and suggestions received on the draft rules and consulted the Drugs Technical Advisory Board.AiMeD has urged the government to reconsider the requirement, saying patient safety and traceability should be ensured without affecting the competitiveness of Indian manufacturers and their exports.Get the latest India News and Live updates. Download the TOI app.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 MediaVideosYoutuber Ajeet Bharti Lists 4 Big Demands At Jantar Mantar, Calls For Reservation Reform And MeritPM Modi Meets BJP’s New Team At Delhi HQ As Party Pushes Vande Mataram Legacy Nationwide‘48 Hours Or Sit-In’: Abhijeet Dipke Warns After CJP Team Allegedly Attacked Near Jaipur SchoolIndiGo Delhi-Gorakhpur Flight Makes Two Go-Arounds, Suffers Tail Impact During Third LandingPunjab Gangster’s Thar Rams Coconut Seller During Police Chase, CCTV Captures Entire IncidentRajasthan School Crisis: 611 Schools Lack Buildings, Thousands More Face Unsafe InfrastructureBJP Builds Gen Z Team As Rahul Gandhi Takes Student Outreach To Pune With ‘Chhatron Ki Goonj’SC-ST Act Repeal, Creamy Layer Demand: Protesters Seek Major Overhaul Of India’s Reservation SystemBCI Chief Manan Mishra Rejects CJP’s Resignation Demand, Says Lawyers Can Never Be CockroachesH1N1 Cases Rise In Delhi: Health Minister Nadda Holds Meet, Reviews Swine Flu Situation123Photostories5 signs you have a TOXIC wifeNayanthara’s ivory saree, gold choker and gajra are a masterclass in minimal but classic Onam style10 meaningful baby boy names inspired by positive human qualities10 famous foods that became popular when people had very little moneyFrom Ed Sheeran to Elton John: Stars who stay away from technologyBandhani to Leheriya: Indian textiles fashion lovers often mistake for each other7 telltale signs your ‘office bestie’ is quietly competing with youHair fall getting worse every monsoon? Expert explains what humidity, sweat and rainwater are doing to your scalp and how to prevent itFrom a net worth of over Rs 2,000 crores to a lavish house in Delhi: Shalini Passi’s luxurious lifestyleHow to wash citrus fruits properly to remove wax, germs and dirt123Hot PicksTCS laptop monitoring softwareTNEA counselling3 year practice ruleCM Revanth ReddyWeather tomorrowNEET UG 2026US-Canada tradeSIM card rulesBank holiday todayTop TrendingMumbai Rape AirhostessReservation Hatao AndolanLucknow Double Murder SuicideMadhapur Road AccidentMaharashtra Hill TragedyAbhijeet DipkeJharkhand Factory FireRahul GandhiBengaluru RapidoAston Martin Crash
NEW DELHI: Medical device manufacturers have raised concerns over a new government rule requiring companies to print the licence number of an outsourced sterilisation facility on device labels, saying it could add to compliance burden and delay exports.The health ministry, in a notification dated August 14, 2026, amended the Medical Devices Rules, 2017, requiring manufacturers that outsource sterilisation to a licensed facility to mention its licence number on the device label. The requirement will become mandatory six months after the notification.The Association of Indian Medical Device Industry (AiMeD) has opposed the move, saying manufacturers are already being asked to obtain “loan licences” for using external gamma radiation or ethylene oxide (EO) sterilisation facilities.AiMeD said manufacturers had sought an exemption through the Medical Device Technical Advisory Group (MDTAG), but the new labelling requirement has instead added another compliance burden.The association said the rule could affect export shipments, as manufacturers may not be able to switch to another sterilisation facility if the one named on the packaging has a backlog or is unavailable. It claimed this could delay shipments by two to three weeks, compared with about a week earlier.AiMeD also questioned the need to print the subcontractor’s details on the product, saying manufacturers remain responsible for quality and traceability, with batch-level records already allowing the sterilisation process to be tracked.
Share your thoughts in the comments
Be respectful · TOI community guidelines
The industry body has sought clarity on whether overseas manufacturers and their sterilisation facilities will also need Indian licences and whether the requirement will apply to their packaging.It has also sought clarity on how manufacturers should handle existing packaging stock before the new requirement takes effect.The notification provides a six-month transition period and was issued after the government considered objections and suggestions received on the draft rules and consulted the Drugs Technical Advisory Board.AiMeD has urged the government to reconsider the requirement, saying patient safety and traceability should be ensured without affecting the competitiveness of Indian manufacturers and their exports.
