Medical device labels must now show sterilisation facility licence number
Synopsis
India has quietly rewritten the labelling rules for medical devices — any manufacturer outsourcing sterilisation must now print the facility's licence number on the packaging. Industry body AiMeD warns this breaks from global norms and could delay export shipments by up to three weeks, putting Indian manufacturers at a disadvantage in international markets.
Key Takeaways
The Ministry of Health and Family Welfare has amended Rule 44 of the Medical Devices Rules, 2017 via gazette notification on 23 August .
Medical device manufacturers outsourcing sterilisation must now print the licence number of the sterilisation facility on product labels.
AiMeD forum coordinator Rajiv Nath warned export shipments could face delays of two to three weeks due to reduced flexibility in switching sterilisation facilities.
AiMeD claims no other jurisdiction requires subcontractor details on medical device packaging, potentially disadvantaging Indian exporters.
The amendment follows a CDSCO clarification — issued nearly a year earlier — that a loan licence is not required for outsourced sterilisation to a validly licensed facility.
The Ministry of Health and Family Welfare has mandated that medical device manufacturers outsourcing sterilisation must print the licence number of the sterilisation facility on their product labels, in a move aimed at strengthening traceability and accountability across India's medical device sector. The directive, issued on 23 August, amends Rule 44 of the Medical Devices Rules, 2017, through a gazette notification.
What the Amendment Requires
Under the revised rule, wherever a manufacturer outsources sterilisation to an external facility holding a valid licence for the process, the licence number of that sterilisation site must appear on the device label. Sterilisation — the elimination or reduction of microbial contamination to safe levels — is a critical step in ensuring medical devices are fit for use in healthcare environments.
The government's stated objective is to improve device traceability and establish clear accountability for the sterilisation stage, which has historically remained opaque in outsourced supply chains.
Industry Pushback
Domestic medical device manufacturers have raised concerns, arguing the new requirement adds to their compliance burden without resolving broader issues around outsourced sterilisation. Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD), said the mandate could create particular difficulties for export shipments.
'Depending on cobalt strength and backlog, shipments could be delayed by two to three weeks, instead of being dispatched within a week,' Nath said, pointing to the loss of flexibility in shifting production between approved sterilisation facilities based on turnaround time and available capacity.
Global Regulatory Comparison
AiMeD argued that in most international regulatory frameworks, quality and traceability obligations rest with the manufacturer — with batch-level accountability maintained through company documentation rather than packaging disclosures. The industry body claimed that no other jurisdiction currently requires subcontractor details to be printed directly on medical device packaging.
This divergence from global norms, AiMeD contended, could put Indian medical device manufacturers at a competitive disadvantage in international markets, particularly in export-sensitive segments.
Regulatory Context
The amendment follows a related clarification issued nearly a year earlier, when the Central Drugs Standard Control Organisation (CDSCO) informed drug authorities across states and Union Territories that a loan licence may not be required for medical technology companies outsourcing sterilisation to a separately licensed facility. The latest gazette notification builds on that clarification by adding a labelling disclosure layer.
With India's medical device industry increasingly integrated into global supply chains, how the government balances traceability goals against export competitiveness will be closely watched in the months ahead.
Point of View
But the government has not addressed AiMeD's core concern: that labelling the subcontractor rather than holding the manufacturer accountable through documentation is a structural departure from how every major regulatory market — US FDA, EU MDR — handles this. If Indian exporters must now lock in a single sterilisation facility per label batch, the operational cost is real and the competitive risk is not theoretical. The CDSCO's own earlier clarification removed the loan licence requirement to ease outsourcing; this amendment partially reverses that flexibility. The ministry would benefit from publishing a comparative regulatory review before the rule takes full effect.
NationPress
24 Aug 2026
Frequently Asked Questions
What does the new medical device labelling rule require?
The amended Rule 44 of the Medical Devices Rules, 2017 requires that wherever a medical device manufacturer outsources sterilisation to a licensed external facility, the licence number of that sterilisation site must be printed on the device label. The gazette notification was issued on 23 August.
Why has the government introduced this requirement?
The Ministry of Health and Family Welfare says the change is aimed at improving traceability and accountability in the medical device sector, particularly for the sterilisation stage, which is critical to device safety in healthcare settings.
What concerns has the industry raised?
AiMeD, the industry body representing domestic medical device manufacturers, has argued the rule adds compliance burden and limits manufacturers' ability to switch between approved sterilisation facilities. Forum coordinator Rajiv Nath warned that export shipments could be delayed by two to three weeks as a result.
How does this compare with global regulatory norms?
AiMeD contends that no other major jurisdiction — including the US or EU — requires subcontractor sterilisation details to be printed on device packaging. In most frameworks, the manufacturer bears traceability responsibility through internal documentation rather than label disclosures.
What was the CDSCO's earlier position on outsourced sterilisation?
Nearly a year before this amendment, the Central Drugs Standard Control Organisation informed state and Union Territory drug authorities that a loan licence is not required when a medical technology company outsources sterilisation to a facility that already holds a valid licence for the process. The new labelling rule builds an additional disclosure requirement on top of that clarification.
