フィリピンFDA：CMDNかCMDRか

CMDN or CMDR: which do you need? In the Philippines, the answer depends on your device's risk class. And since October 2024, Classes B to D can only apply for a CMDR. The FDA's device center, CDRRHR, uses the ASEAN risk classes. Class A, the lowest risk, gets a notification certificate, the CMDN. Classes B, C and D need a registration certificate, the CMDR, built on the ASEAN common dossier. Since October 1, 2024, Class B, C and D devices can only apply for a CMDR. If an ASEAN regulator approved the same device, abridged review takes 30 working days. And on June 9, 2026, the new fee schedule was suspended again. The rule is strict. Selling a Class B, C or D device without a certificate or a pending application is prohibited, and FDA publishes warnings naming unregistered products. Start with three things. One: classify the device under the ASEAN rules. Two: file through a licensed Philippine establishment. Three: budget for fees that may change when the suspension ends. Know your class, then file. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.