Sterilisation Labelling Rule Sparks Industry Concerns in India’s Medical Device Sector
A new sterilisation labelling rule has been introduced under the Medical Devices (Second Amendment) Rules, 2026. Effective from February 2027, the rule requires manufacturers outsourcing sterilisation to print the licence number of the sterilisation facility on...
5 Pro Tips for Effective FDA Communication for Medical Devices
FDA communication for medical devices is the structured process through which manufacturers interact with the U.S. FDA. The aim is to ensure compliance, safety, and timely approval of the products. It includes pre-submission meetings to clarify requirements, formal...
10-Step Guide to Start Selling Medical Devices in Europe
Selling medical devices in Europe is strategically valuable because the EU market is one of the largest and most regulated healthcare markets in the world. Achieving CE marking under the EU MDR or IVDR not only allows entry into Europe but also signals global...
Health Canada Post-Market Surveillance Requirements
Health Canada requires medical device manufacturers to conduct ongoing post-market surveillance. Mandatory summary reports, issue-related analyses, incident reporting, and foreign risk notifications are necessary requirements. Notably, these obligations apply...