UC MedAccess provides regulatory support for medical device and in vitro diagnostic (IVD) manufacturers seeking to enter the Philippine market. We support manufacturers in navigating Food and Drug Administration (FDA) regulatory requirements, from product classification and registration strategy through submission support and ongoing regulatory compliance.
Philippines Medical Device Regulatory Framework
Medical devices supplied in the Philippines are regulated by the Philippine Food and Drug Administration (FDA). Regulatory requirements depend on factors including device classification, intended use, risk profile and the applicable registration pathway.
UC MedAccess works with manufacturers to assess the appropriate regulatory requirements and prepare for market entry into the Philippines.
Medical Device Classification in the Philippines
The Philippines classifies medical devices according to risk:
Class A: Low risk
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High risk
Correct classification is an important first step because it determines the regulatory requirements and registration considerations applicable to the device.
Our Philippines FDA Regulatory Support Services
UC MedAccess can support medical device and IVD manufacturers with:
- Medical device classification and regulatory assessment
- Philippines regulatory and registration strategy
- FDA medical device registration support
- IVD regulatory and registration support
- Technical and regulatory documentation review
- Preparation and coordination of regulatory submissions
- Management of regulatory queries during the registration process
- Registration maintenance and change notifications
- Post-market regulatory support
Medical Device Registration in the Philippines
Medical devices generally require the appropriate authorization from the Philippine FDA before they can be placed on the Philippine market, subject to applicable regulatory requirements.
The registration process and supporting documentation depend on factors including the device classification and applicable regulatory requirements.
UC MedAccess can assess a device's regulatory background and documentation to help determine the appropriate registration approach for the Philippines.
IVD Registration in the Philippines
In vitro diagnostic (IVD) medical devices are regulated by the Philippine FDA according to their intended purpose and risk classification.
UC MedAccess supports IVD manufacturers with regulatory assessment, classification, registration strategy, technical documentation review, submission support and ongoing regulatory requirements in the Philippines.
For manufacturers seeking access to multiple Southeast Asian markets, we can also coordinate regulatory planning across the Philippines, Singapore and Malaysia.
Regulatory Support for Overseas Manufacturers
Overseas manufacturers entering the Philippines may require local regulatory and market access support to navigate FDA requirements and maintain their products following registration.
UC MedAccess works with international medical device and IVD manufacturers to provide regulatory support in the Philippines while coordinating broader market access requirements across Southeast Asia.
Why Manufacturers Choose UC MedAccess
UC MedAccess combines local regulatory knowledge with coordinated market access capabilities across the Philippines, Singapore and Malaysia.
Local Regulatory Support
Regulatory guidance tailored to the requirements of each market.
Regional Coverage
Regulatory support across the Philippines, Singapore and Malaysia.
One Regional Partner
Coordinate regulatory strategy, registration and ongoing compliance across multiple Southeast Asian markets through a single partner.
Frequently Asked Questions
Who regulates medical devices in the Philippines?
Medical devices in the Philippines are regulated by the Philippine Food and Drug Administration (FDA).
What are the medical device risk classes in the Philippines?
Medical devices are classified according to risk into Class A, Class B, Class C and Class D, with regulatory requirements increasing according to the level of risk.
Does UC MedAccess support IVD registration in the Philippines?
Yes. UC MedAccess provides regulatory support for in vitro diagnostic medical devices, including regulatory assessment, classification, registration strategy, documentation review and submission support.
Can UC MedAccess support registration outside the Philippines?
Yes. UC MedAccess provides medical device and IVD regulatory support across the Philippines, Singapore and Malaysia, allowing manufacturers to coordinate regulatory activities across multiple Southeast Asian markets.
Can UC MedAccess assist overseas manufacturers entering the Philippines?
Yes. UC MedAccess works with international medical device and IVD manufacturers seeking regulatory and market access support for the Philippines and other Southeast Asian markets.
Discuss Your Philippines Regulatory Requirements
Planning to register a medical device or IVD in the Philippines?
Contact UC MedAccess to discuss your product, existing regulatory approvals and intended Southeast Asian markets. Our regulatory team can help assess the appropriate approach for your Philippine market entry.