Health Canada Regulatory Pathways for IVDs: Complete Guide
Health Canada regulates in vitro diagnostic devices (IVDs) under the Medical Devices Regulations. It uses a risk-based classification system (Class I–IV) to determine the applicable regulatory pathways. Class II–IV IVDs require a Medical Device Licence (MDL). On the...
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...