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What Is a Medical Device?

Medical Device Act B.E. 2562 (2019) · Thai FDA / MDCD

Statutory Definition​

Under Thailand's Medical Device Act B.E. 2562 (2019), a medical device is any instrument, apparatus, implement, machine, implant, in vitro reagent, software, or other similar article — including accessories — that is:

  • Intended by the manufacturer to be used alone or in combination for human beings
  • For purposes of diagnosis, prevention, monitoring, treatment, alleviation of disease or injury
  • For investigation, replacement, or modification of anatomy or physiological processes
  • For control of conception

The device's intended action must not be achieved principally by pharmacological, immunological, or metabolic means — that distinction separates devices from pharmaceuticals.

What Is an IVD?​

An in vitro diagnostic (IVD) medical device is a device — including reagents, kits, instruments — intended for examination of specimens from the human body to obtain information about:

  • Physiological or pathological states
  • Congenital abnormalities
  • Safety and compatibility of potential recipients

IVDs are classified within the same Class 1–4 framework using ASEAN AMDD IVD classification rules, which account for user expertise (professional vs lay) and clinical impact of incorrect results.

What Is Not a Medical Device?​

The following are generally excluded from Thai FDA medical device regulation:

  • Pharmaceutical drugs — principal action pharmacological, immunological, or metabolic
  • Cosmetics — products with purely aesthetic functions
  • Food supplements — nutritional products without medical claims
  • General consumer goods — no medical intended purpose stated by manufacturer

Software as a Medical Device (SaMD)​

Software with a medical intended purpose is included within the Thai medical device definition. Classification follows standard Class 1–4 rules based on the software's clinical function and risk. See Classification: SaMD & Combination Products.

Accessories​

Accessories specifically intended for use with a medical device to enable or assist its function are regulated as medical devices in their own right and classified independently.

B.E. Year Notation

Thai legislation uses Buddhist Era (B.E.) year numbering. B.E. = CE year + 543. The Medical Device Act "B.E. 2562" is the 2019 CE Act. See Regulatory Framework for the B.E. year guide.