Patients in India will be able to gain faster access to some new medical devices that have already received approval in the European Union. The Indian government is expanding the list of trusted foreign regulatory jurisdictions and simultaneously easing licensing requirements for manufacturers who outsource the sterilization process.
However, manufacturers will be required to affix the sterilization facility's license number to the product label, with a six-month deadline set for compliance with this requirement. Previously, the labeling requirement raised concerns among industry representatives regarding increased compliance burden and potential export delays.