The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.

ISO has published new standards and updates for medical devices, health technologies and pharmaceuticals. Among the main standards are requirements for respiratory equipment, risk management in heart valves, cybersecurity in telehealth and digital integration in health. These updates aim to improve the safety, efficacy and regulatory compliance of medical products globally.

Health Canada has announced new guidance for Risk Management Plans (RMPs), reinforcing the need for pharmacovigilance and risk minimization throughout the life cycle of medicines. As of April 2027, the submission of RMPs will be mandatory in certain circumstances, such as for new drugs, biosimilars and cases of emerging risks. This update harmonizes Canadian regulations with international standards, ensuring greater safety for patients and transparency in the regulatory process. Manufacturers wishing to market products on the Canadian market must adapt to these new requirements.

The proposed revision of IEC 62304 brings important changes for the development of software for medical devices and other healthcare applications. The new version expands the concept of Health Software to include solutions that assist in health management and monitoring, even without being classified as medical devices. Among the main changes are the simplification of the classification of software rigor, the removal of specific Quality System requirements and the revision of Risk Management, which no longer requires ISO 14971. In addition, the approach to legacy software will be reformulated, with guidelines transferred to an informative annex. As this update is still in the proposal stage, manufacturers should keep an eye on the changes and prepare for future adaptations.