Moving to align its system for approving the sale of medical devices with those of other Association of Southeast Asian Nations (ASEAN) countries, the Philippines Food and Drug Administration in February announced new requirements for registering and regulating such products. The new rules impose new technical and application requirements and fees on companies marketing the devices in the archipelago nation.
The new rules set out technical requirements and procedures for the regulation of medical devices classified as Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). Class (low risk) A devices have been subject to registration requirements in the Philippines since 2018, when the country first began harmonizing its requirements for medical device approvals with those established by the ASEAN Medical Device Directive, signed by all 10 member states four years earlier. In the past, although this has changed now, higher-risk devices remained exempt from registration requirements and could still be exported to the Philippines.