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What Is a Medical Device?

RA 9711 · DOH AO 2018-002 · FDA Philippines / CDRRHR

Statutory Definition​

Under Philippines law (RA 9711 and DOH Administrative Order No. 2018-002), a medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar article — whether used alone or in combination — that is:

  • Intended by the manufacturer for use in or on human beings
  • For the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease
  • For diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap
  • For investigation, replacement or modification of anatomy or a physiological process
  • For control of conception

The principal intended action must not be achieved by pharmacological, immunological, or metabolic means. A device may be assisted in its function by pharmacological, immunological, or metabolic means without being reclassified as a pharmaceutical product, provided the principal intended action remains mechanical or physical.

What Is an IVD? — PH-Unique Current Status​

An in vitro diagnostic (IVD) medical device is a device — including reagents, calibrators, kits, instruments — intended for examination of specimens from the human body.

IVD Registration — Currently NOT Required — PH-Unique​

A critically important distinction in the Philippines: as of the last review (May 2026), IVD medical devices are currently NOT required to undergo CMDN/CMDR registration with CDRRHR. This means IVDs may currently be imported and commercially distributed without prior CDRRHR registration.

However:

  • This status is expected to change — the Philippines has announced plans to introduce IVD registration requirements
  • An LTO (License to Operate) is still required for entities importing or distributing IVDs
  • Monitor the CDRRHR website and FDA Circulars for the announcement and timeline of IVD registration implementation

See What's New for the latest on IVD registration status.

What Is Not a Medical Device?​

The following are generally excluded:

  • Pharmaceutical drugs — principal action pharmacological, immunological, or metabolic
  • Cosmetics — aesthetic purposes without medical claims
  • Food supplements — nutritional products without medical device claims
  • General consumer goods — no medical intended purpose

Borderline and Combination Products​

Products at the device-drug boundary are assessed based on principal mechanism of action. Contact the CDRRHR for a formal classification inquiry before proceeding. See Classification Overview.

LTO required even for IVDs

Even though IVDs do not currently require CMDN/CMDR registration, all entities handling IVDs (importers, distributors, manufacturers) must hold a valid License to Operate (LTO). See Establishment License & LTO.

Last reviewed: May 2026. For current information, always verify with CDRRHR at www.fda.gov.ph — regulatory requirements may change.