Philippines Medical Equipment Import Process (USA → Philippines)
This guide helps Philippinesn hospitals, clinics, distributors, and licensed importers understand the process of importing pre-owned medical equipment from the United States.
Export-Ready Documentation
All documentation prepared to support Philippinesn customs requirements
Faster Clearance
Reduced customs delays through accurate pre-shipment documentation
Export Support
From quote to shipment, we prepare equipment for export from the USA
Regulatory Authority: Food and Drug Administration Philippines (FDA Philippines)
Pre-owned medical equipment can be legally imported into Philippines with proper documentation and regulatory compliance.
Classification System
Class A (Low Risk), Class B (Low-Moderate), Class C (Moderate-High), Class D (High Risk)
Registration Timeframe
3-6 months for Certificate of Product Registration (CPR)
License Validity
5 years with renewal option
Local Representative
Required for foreign manufacturers
Registration Fees
- • Class A: PHP 5,000-10,000 (~USD 90-180)
- • Class B: PHP 10,000-20,000 (~USD 180-360)
- • Class C: PHP 20,000-40,000 (~USD 360-720)
- • Class D: PHP 40,000-80,000 (~USD 720-1,440)
Import Duties and Taxes
Import duties 0-10% for medical equipment; most devices qualify for duty-free under ASEAN agreements
VAT Rate
12% VAT
Additional Charges
- • FDA registration fees
- • Bureau of Customs processing
- • Documentary stamp tax
Shipping to Philippines
Air Freight
Transit: 5-10 business days
Airport: Ninoy Aquino International Airport (MNL), Manila
Sea Freight
Transit: 4-6 weeks
Port: Port of Manila / Manila International Container Port
Buyer Responsibility Notice
Buyer is responsible for all Philippinesn regulatory approvals including FDA Philippines registration, customs clearance, duties, and post-import certification. Rotala International provides export documentation from the USA; all Philippinesn import compliance is the buyer's responsibility.
Required Documents Checklist
From Rotala International (USA)
- Commercial Invoice
- Packing List
- Bill of Lading / Airway Bill
- Certificate of Origin
Required in Philippines
- FDA Certificate of Product Registration (CPR) or Certificate of Medical Device Notification (CMDN)
- License to Operate (LTO) from FDA Philippines
- Certificate of Free Sale from country of origin
- ISO 13485 or equivalent quality certification
- Technical documentation and product specifications
Ready to Import Medical Equipment to Philippines?
Browse our available inventory or contact us for a personalized Philippines export quote.