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IVD Registration — Current Status & Upcoming Requirements

PH-Unique · Currently NOT required · Upcoming regulation pending

Current Status (as of May 2026)​

IVD medical devices are currently NOT required to undergo CMDN or CMDR registration with CDRRHR in the Philippines. This means:

  • IVD devices (diagnostics, laboratory reagents, test kits) may currently be imported and commercially distributed without a CMDN or CMDR certificate
  • This situation is transitional — the Philippines has signalled intention to introduce mandatory IVD registration
  • An LTO (License to Operate) remains mandatory for all entities importing or distributing IVDs

Why the Exemption?​

IVD regulation is typically more complex than general medical device regulation, requiring specialised analytical performance standards and evaluation capabilities. The Philippines, like several other ASEAN markets, implemented general medical device registration first and is moving toward IVD regulation in a phased manner.

What to Expect​

Based on CDRRHR announcements and ASEAN harmonisation progress, IVD registration requirements in the Philippines are expected to:

  • Follow the ASEAN AMDD IVD classification framework (IVD Class A–D)
  • Require CMDN for Class A IVDs and CMDR for Class B/C/D IVDs
  • Be introduced with a transitional period to allow manufacturers to prepare dossiers
  • Include the abridged pathway (via ASEAN NRA reliance) for IVDs approved by recognised reference NRAs

Action Items for IVD Manufacturers​

  1. Confirm current status: Check the CDRRHR website for the latest announcement on IVD registration implementation date
  2. Obtain LTO now: Ensure your Philippines LTO is in place as an importer/distributor — this is required regardless of IVD registration status
  3. Prepare ASEAN CSDT dossier: Begin technical dossier preparation for your IVD product lines, so you are ready for the registration window
  4. Classify your IVDs: Apply ASEAN AMDD IVD classification rules to understand which products will require CMDR (Class B/C/D) vs CMDN (Class A)
  5. Identify reliance opportunities: If your IVDs are already approved by an ASEAN NRA (HSA, MDA, Thai FDA, etc.), the abridged pathway will likely apply

Monitoring This Page​

This page is updated as new information becomes available from CDRRHR. Check the CDRRHR website for formal implementation announcements: www.fda.gov.ph/center-for-device-regulation-radiation-health-and-research/