Overview on Regulatory Requirements for Medical Devices in Srilanka - National Medicines Regulatory Authority/NMRA

Abstract

In the health-care industry, medical devices are becoming increasingly significant. One of the most challenging aspects of developing and manufacturing medical devices is keeping up with regulatory regulations and incorporating them into the process Registration, licensing, manufacture, importation, and all other elements of medical devices shall be regulated and controlled by the National Medicines Regulatory Authority in accordance with the National Medicines Policy. In this article we discuss about regulatory overview and registration of medical devices in Sri Lanka. A “medical device,” as defined by the Act, is any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, that is used in or on humans for the purposes of:  Diagnosis, prevention, monitoring, treatment, or alleviation of disease; Anatomy or physiological process investigation, replacement, or alteration, Conception control. Any change in product information should be reported to the NMRA as soon as possible during the evaluation process and after product registration, especially if it involves rejection/withdrawal, additional data on product quality, effectiveness, or safety, or the manufacturers' current Good Manufacturing Practice (cGMP) compliance. The sample license will be produced in three copies, each of which will be valid for one year from the date of issue, and will be available for pick-up at the reception point. (An extra copy of the dossier will be included).