This week, we cover more ANVISA updates from Brazil, including new labeling requirements for certain devices and a clear path for registration transfers, along with new appraisal requirements for high-risk devices in Vietnam.

The platform amalgamates data from over 30 markets, providing various tools to navigate regulatory requirements, monitor medical device registrations, and analyse clinical trials utilising AI-driven insights.

Regulatory authorities have long expected medical device companies to manage the cybersecurity of their products effectively.

The platform consolidates data from over 30 global markets, combining local expertise to simplify global standards and identify optimal market entry routes.

September 2024 brings several medical device regulatory developments in Singapore, new ASEAN classification guidance in Malaysia, imminent UDI implementation in Colombia, and more.

A summary of July and August 2024 medical device and IVD regulatory developments, including insights on the IVDR transition extension, Eudamed and Swissdamed module roll outs, and more.

With minimal regulatory barriers, developers can expedite product development cycles health and wellness apps. However, developers of health products need to be aware that market pressures may eventually lead to initial product designs being classified into new regulatory categories.

Starting August 2024, the Agency will process requests via RIMS, expand consultations for China's med device industry, and launch an NPRA pilot project.

Health Canada updates device standards: new version recognition, 6 new, 12 updated. Temporary inspections start July 1, 2024. Consultation: July 25 - Sep 23, 2024. Stay informed!