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What Is a Medical Device?

NMRA Act No. 5 of 2015 · Sri Lanka regulatory definition

Statutory Definition​

Under Sri Lanka's NMRA Act No. 5 of 2015, a medical device is any instrument, apparatus, appliance, software, material, or other article — whether used alone or in combination — that is intended by its manufacturer to be used in or on human beings for:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap
  • Investigation, replacement or modification of anatomy or a physiological process
  • Control of conception

The device's principal intended action must not be achieved by pharmacological, immunological, or metabolic means — that distinction separates devices from medicines. However, a device may be assisted in its function by such means.

What Is an IVD?​

An in vitro diagnostic medical device (IVDMD) is a device — including reagents, calibrators, control materials, kits, instruments, apparatus — intended for examination of specimens derived from the human body to provide information about:

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

IVDs are classified separately from general medical devices under Class A, B, C, D using NMRA's IVD-specific classification rules.

What Is Not a Medical Device?​

The following are generally excluded from the medical device definition:

  • Pharmaceuticals — products whose principal action is pharmacological, immunological, or metabolic
  • Cosmetics — used for aesthetic purposes without medical claims
  • General consumer goods — no medical intended purpose
  • Pure research tools — instruments used exclusively for scientific research without clinical claims

Software as a Medical Device​

Software with a medical intended purpose is included within the device definition and subject to NMRA registration. NMRA applies IMDRF-aligned SaMD principles for classification. Software whose sole purpose is storage, archiving, or communication of data without interpretation is generally not a medical device.

Borderline Products​

Products at the interface between a medical device and a pharmaceutical are assessed on the basis of the principal mechanism of action:

  • Principal action physical/mechanical → medical device (NMRA)
  • Principal action pharmacological/immunological → pharmaceutical (regulated under drug law)

Contact the NMRA for a formal determination if classification is uncertain. Do not proceed with registration without confirming the applicable regulatory pathway.

Classification is the first step

Once confirmed as a medical device, determine the risk class. See Classification Overview.