Japan's position as the world’s second-largest medical device market, with a population of over 123 million and approximately 35% of medical devices imported, presents significant opportunities for global manufacturers. The country's advanced healthcare system and regulatory environment offer a fertile ground for high-quality medical devices seeking PMDA medical device registration.
Swissmedic’s 2025 update to the Good Practices for Endoscope Reprocessing (GPAE) clarifies legal duties under the Swiss MedDO and aligns hygiene standards with the latest science. Prompted by compliance gaps revealed in hospital inspections, the guidance requires healthcare providers to update procedures, training, and documentation.
This video explains Philippines FDA (CDRRHR) rules for device classification, dossiers, labeling, and the critical role of a local representative.
Explore articles and insights our team has published in leading media and industry platforms.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
