New guidance from the TGA outlines compliance expectations for manufacturers and sponsors of medicinal cannabis vaping devices with safety and performance standards.
Manufacturers must generate and maintain scientific, engineering, and clinical evidence demonstrating that their devices meet the Essential Principles for Safety and Performance.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Outlines expectations for meeting Essential Principles; consolidates references to relevant industry standards for safety and performance of medicinal cannabis vaping devices.
Manufacturers and sponsors must ensure that medicinal cannabis vaping devices comply with the outlined safety and performance standards, which is critical for medical device vigilance and post-market safety monitoring.
Manufacturers and sponsors are now required to comply with established safety and performance standards for medicinal cannabis vaping devices as outlined in the TGA guidance.
Compliance with these standards is essential for ensuring the safety and efficacy of medicinal cannabis vaping devices, thereby enhancing post-market safety monitoring efforts.
Manufacturers must generate and maintain scientific, engineering, and clinical evidence demonstrating that their devices meet the Essential Principles for Safety and Performance.
Manufacturers must adjust labeling workflows to incorporate e-labelling mechanisms, such as QR codes, for P and GSL medicines by the stipulated date.
Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.
Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.
Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.
