Classification of Medical Devices and IVDs In Sri Lanka

Degree of Invasiveness

Intended Purpose / Use Condition

Device Class

Non-invasive

Do not touch the patient or contact only intact skin

Class I

Channeling or storing for eventual administration

Class I

In contact with injured skin (mechanical barrier – (absorb exudates)

Class I

Channeling or storing blood or other body liquids or for storing organs, and parts of organs or body cells

Class IIa

Channeling or storing for eventual administration connected to an active medical device

Class IIa

In contact with injured skin (mechanical barrier – (absorb exudates) intended to manage microenvironment of the wound

Class IIa

Used only for filtration, centrifugation, exchange of gas or heat

Class IIa

In contact with injured skin (mechanical barrier – (absorb exudates) intended for the wound which breach dermis and heal only secondary intent

Class IIb

Modify biological or chemical composition of blood, body-liquids, and other liquids intended for infusion

Class IIb

Duration of Contact

Intended Purpose / Use Condition

Device Class

Transient use

Reusable surgical instrument

Class I

Others

Class IIa

Supply energy/ionizing radiation

Class IIb

Has biological effect- mainly absorbed

Class IIb

System to administer medicines

Class IIb

Diagnosis/control of defect of heart/circulatory system

Class III

Short Term

Others

Class IIa

Supply energy/ionizing radiation

Class IIb

Undergo chemical change in body/system to administer medicines (not teeth)

Class IIb

Has biological effect- mainly absorbed

Class III

Specifically to monitor/correct defect of heart/circulatory system – by contact

Class III

For use in direct contact with Central Nervous System

Class III

Long Term / Implantable devices

To be placed in teeth

Class IIa

Other devices

Class IIb

Used in direct contact with heart or central circulatory/nervous system

Class III

Biological effect or mainly absorbed

Class III

Undergo chemical change in body/system to administer medicines (not teeth)

Class III

All other active devices

Class I

Therapeutic devices to administer or exchange energy

Class IIa

Administer/remove medicines and other substances to/from the body

Class IIa

For diagnosis/monitoring vital physiological processes

Class IIa

Administer/remove medicines and other substances to/from the body in a hazardous way

Class IIb

All active devices intended to emit ionizing radiation for therapeutic purposes, including devices that control or monitor such devices

Class IIb

Devices intended for In vivo imaging of the radiopharmaceuticals

Class IIb

Devices intended to allow direct diagnosis or monitoring of vital physiological processes

Class IIb

All active devices that are intended for controlling, monitoring or directly influencing the performance of active implantable devices

Class III

Reagents/instruments for In vitro diagnostics

Class A

Physiological markers/metabolic markers

Class B

IVD medical devices that control without a quantitative or qualitative assigned value

Class B

IVD medical devices intended to be used for blood grouping/ tissue typing/self-testing

Class C

Intended for detecting the presence of sexually transmitted agent/infectious agent

Class C

Devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs in order to assess their suitability for transfusion or transplantation, life-threatening disease

Class D