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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.

Reagent suppliers and component manufacturers selling to IVD kit manufacturers are not required to register directly with the NMRA. Only the manufacturer of the final assembled IVD kit, or the MAH marketing it in Sri Lanka, must obtain NMRA registration. However, the Consolidated Dossier must document all components and their suppliers.