FDA Philippines · LTO · CMDN / CMDR registration
The Philippines is a large, growing market with strong public-health and private-hospital demand. Medical devices are regulated by the Food and Drug Administration (FDA Philippines) through its Center for Device Regulation, Radiation Health and Research.
The importing/distributing company in the Philippines must hold a valid License to Operate (LTO) as a medical device importer/distributor. The LTO is held by the local entity, not the overseas supplier. SWIFTSKY supplies the manufacturer and certification documentation needed for product notification/registration.
Depending on device class, products require either a Certificate of Medical Device Notification (CMDN, lower-risk) or a Certificate of Medical Device Registration (CMDR, higher-risk) before sale.
Honest note: The LTO and the relevant CMDN/CMDR must be in place before commercial import. First-time registration commonly takes 2–6 months depending on class and route. We supply all manufacturer documentation; the LTO and registrations are held by the buyer.
| Item | Rate | Notes |
|---|---|---|
| Import duty — medical devices (general) | 0–5% | ASEAN/MFN tariff; many medical items 0–1% |
| VAT | 12% | Some health products are exempt |
| Customs / clearance charges | Variable | Confirm with your customs broker |
Rates are indicative. Verify current AHTN codes and rates with a licensed Philippine customs broker before importing.
We supply all the manufacturer documentation your CMDN/CMDR needs. You handle the LTO; we handle the supply chain.