New Sterilisation Labelling Rule Sparks Industry Debate
Recently, the health ministry amended the Medical Devices Rules, 2017 to introduce a new sterilisation labelling rule. Under this mandate, manufacturers who outsource sterilisation must print the subcontractor's licence number on the device packaging. Consequently, medical device makers have expressed concerns regarding increased compliance burdens and potential export bottlenecks.
Key Provisions of the Sterilisation Labelling Rule
Under amended Rule 44, companies outsourcing sterilization must display the subcontractor's licence number on the product label. Moreover, the government provides a six-month transition period from the notification date to achieve compliance. Regulators aim to strengthen supply chain traceability and ensure patient safety across healthcare facilities. Therefore, authorities believe identifying the facility on the pack enhances accountability during adverse event investigations.
Industry Concerns and Export Challenges
However, the Association of Indian Medical Device Industry has raised strong objections to the new mandate. The industry body notes that manufacturers already maintain comprehensive batch-level records for full traceability. Furthermore, requiring a fixed licence number on outer packaging severely restricts supply chain flexibility. For instance, manufacturers cannot easily reroute batches if a designated sterilization plant faces backlogs. Consequently, export shipments could face delays of up to three weeks.
Pending Regulatory Clarifications
In addition, industry representatives have sought crucial clarifications regarding overseas medical devices. Manufacturers want to know whether foreign production units must also print Indian facility details on imports. Furthermore, companies need clear guidance on managing pre-printed inventory before the transition window closes. Ultimately, AiMeD has urged the health ministry to reconsider the rule to protect export competitiveness.
Frequently Asked Questions
Q1: What does the new sterilisation labelling rule require?
The rule requires medical device manufacturers that outsource sterilisation to print the valid licence number of the subcontracted sterilisation facility directly on the device label.
Q2: When will the updated labelling mandate take effect?
The health ministry notified the amendment on August 14, 2026, granting manufacturers a six-month transition window before compliance becomes mandatory.
Q3: Why are MedTech manufacturers concerned about the change?
Industry bodies fear that fixing a specific facility licence number on packaging limits operational flexibility, creates compliance hurdles, and potentially delays export consignments by up to three weeks.
References
- Medical device makers flag new sterilisation labelling rule - ETHealthworld
- The Times of India. Medical device makers flag new sterilisation labelling rule. August 23, 2026.
- Ministry of Health and Family Welfare, Government of India. Medical Devices Rules, 2017.
