Government Revises Medical Device Rules to Ease Outsourced Sterilisation Licensing

Medical device manufacturers outsourcing sterilisation to an already licensed facility will no longer need a separate loan licence for the process under proposed changes to the Medical Devices Rules, 2017, as per The Economic Times news report. 

The amendment to Rule 44 is part of a wider set of changes proposed by the Union Health Ministry. Earlier, manufacturers were required to obtain a separate loan licence even when the facility carrying out the sterilisation held a valid licence. 

The change removes this additional licensing step for outsourced sterilisation, provided the facility is licensed under the Medical Devices Rules, 2017. 

Labelling Requirement Retained 

The proposed rules, however, require manufacturers to print the licence number of the sterilisation facility on the label of the medical device. This requirement has been retained to maintain traceability of the sterilisation process. 

Companies will have six months to make changes to labels, packaging, and related processes. The transition period is intended to allow manufacturers to update existing products and packaging before the revised requirement takes effect. 

The Association of Indian Medical Device Industry, or AiMed, has raised concerns over the labelling provision and sought a review from the Health Ministry. 

Industry Raises Concerns 

AiMed forum co-ordinator Rajiv Nath said mentioning a specific facility's licence number on packaging could reduce manufacturers' flexibility in choosing another available sterilisation facility. 

According to Nath, this could increase shipment turnaround to two to three weeks from the current period of under a week. The industry body has asked the ministry to suspend the provision and hold further discussions with stakeholders. 

The medical device loan licence allows a company to use its own brand name on products manufactured by another licensed manufacturer. Under the new provision, such a licence will not be required specifically for the outsourced sterilisation process. 

EU Added to Recognised Jurisdictions 

The government has also amended Rule 63 to include the European Union among jurisdictions recognised for waiving clinical investigation requirements for certain medical devices. 

The US, UK, Australia, Canada and Japan are already covered under the provision. Eligible devices approved in the EU can now seek the waiver in India, subject to the conditions under the rules. 

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Conclusion 

The proposed amendments change the licensing process for outsourced sterilisation and add the EU to the recognised regulatory jurisdictions under Rule 63.  

The labelling requirement will remain, with manufacturers given six months to make the required changes. 

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