The Health Authorities of all countries, with Canada being an exception, require all foreign medical device manufacturers to appoint a local, in-country or Authorized representative. The duty of a legal representative is to represent the manufacturer and the device in the targeted country and to liaison between Health Authorities and the foreign manufacturers. There is country-specific jargon for a local representative. The local representative in the USA is called as a US Agent, and that in the UK is referred to as UKRP (United Kingdom Responsible Person).

Sri Lanka, being majorly driven by imported medical device products, offers a potential market to medical device manufacturers. The medical devices intended to be marketed in Sri Lanka must be registered with the National Medicines Regulatory Authority (NMRA). The registration of medical devices involves a series of activities, including medical device classification into appropriate risk class, obtaining sample import license, manufacturing license, testing of devices in accredited laboratories, and device registration followed by obtaining a commercial import license.

With the growing economy and population, the demand for safe and effective healthcare facilities has increased in Sri Lanka. National Medicines Regulatory Authority (NMRA) of Sri Lanka is responsible for assuring that the medical devices imported into Sri Lanka pertain to high standards of safety, quality and efficacy. For the same reason, NMRA has efficiently crafted the Regulatory approval process with the most critical component - the manufacturing site registration.

Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.