Under rules released in January by the Philippines Food and Drug Administration, all medical devices imported, marketed, or manufactured in the archipelago nation will require registration. Previously, not all medical devices required registration.
The rules, which tighten regulations first put in place in April 2019, are expected to increase costs for medical device manufacturers doing business in the country. The previous regulations established four classes of registration for medical devices, mandating notification requirements and fees in accordance with safety risks, as determined by the Philippines FDA.
Initially, the requirements covered only devices categorized as Class A, which are deemed low safety risk. The amended rules mandate that devices categorized as B, C, and D are now subject to the new requirements and fees. Class B devices are considered low to moderate risk by the Philippines authorities, Class C are deemed moderate to high risk, and Class D are considered high risk. Resuscitators and ventilators will also, for the first time, require registration. To register a device, applicants will need to submit technical documentation, including a description of the device, its shelf life, clear images, and labeling. Registration fees are still very low and have been set at about $60/product, plus a legal research fee of one percent.