Medical device makers now avoid loan licenses for outsourced sterilization services. This change simplifies business while industry leaders express concerns about new labeling rules. Printing sterilizer license numbers on device labels may hinder export flexibility and cause shipment delays. Manufacturers worry about losing the ability to choose the fastest available sterilization facility. The government also recognized the European Union for clinical investigation waivers.

The Ministry of Health has introduced new regulations for medical devices. These reforms simplify requirements and enhance transparency for businesses. Outsourced sterilisation…

The government said it amended the Medical Devices Rules to promote ease of doing business and simplify regulatory processes | India News