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In the Philippines, products that make therapeutic or medical claims—including tools, machinery, in vitro reagents, software, and similar or related items—are referred to as medical devices.
The Center for Device Regulation, Radiation Health and Research (CDRRHR) of the Department of Health overseas medical device registration in the Philippines.
The Philippines Department of Health has issued Administrative Order in an effort to reconcile the Philippine Regulatory Guidelines with the ASEAN Medical Devices Directive. The Administrative Order establishes new criteria for initial device registration and renewal as well as a risk classification system for medical devices.
Only registered medical devices may be imported into the Philippines; to do so, they must be registered with the FDA’s Center for Device Regulation, Radiation, Health and Research (CDRRHR), have received a Certificate of Medical Device Notification (CMDN), a Certificate of Medical.
The Philippines Medical Devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
Class B, C, and D medical devices that have already received approval from a member nation of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access, according to the Philippines FDA’s Circular No-008.
According to AO No-0002, the products must now require a Certificate of Medical Device Registration (CMDR), and the maker must have used the Common Submission Dossier (CSDT) for the products’ authorised application in the ASEAN reference nation.
Additionally, in order for the device to qualify for Reliance registration with the Philippine FDA, the manufacturer must certify that the device itself is the same as described in the earlier paperwork submitted.
The Center for Device Regulation, Radiation Health and Research will now be able to complete the device evaluation procedure in thirty (30) working days following receiving payment documentation (CDRRHR). This represents a significant reduction from the previous assessment period of at least one hundred eighty (180) working days.
