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

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).

EFFECTS OF UNDERWATER LOW-FREQUENCY SOUND PROPAGATION THROUGH CONTINENTAL BARRIER

Обнаружены и исследованы подводный и донный низкочастотные акустические сигналы (400 Гц) от подводного источника излучения, расположенного относительно приемной системы по другую сторону перешейка мыса Шульца. Приемная система состояла из трехкомпонентного донного геофона и приемной акустической комбинированной системы, расположенной в толще волновода на глубине 9 м. Кратчайшее расстояние между источником и приемником через материковый барьер составляет ~ 1000 м. Азимутальный угол прихода сигнала продольных волн совпадает с геометрической линией, соединяющей источник и приемник. Прием поперечной и продольной волн осуществляется по различным ортогональным осям координат геофона. Направление прихода продольной волны в точку измерения близко к горизонтальному. Наличие поперечной волны в донном грунте позволяет предположить, что дно волновода представляет собой твердую жесткую поверхность. The present work studies the underwater and sea bottom low-frequency signals (400 Hz) emitted by the underwater transducer and detected by the receiver system located on the other side of the Schultz cape neck relative to the transducer. The receiver system consisted of a three-component bottom geophone and composite acoustical system immersed 9 m down the water column of the waveguide. The shortest distance between transducer and receiver through the continental barrier was ~1000 m. The azimuth angle of signal arrival corresponds to a geometrical line connecting a pair transducer/receiver. The reception of longitudinal and transverse waves was performed alongside different orthogonal axes of geophone coordinates. The direction of the longitudinal wave arrival at the reception point was close to horizontal. The presence of the transverse wave in the bottom soil suggests that the bottom of the waveguide represents a solid rigid surface.

A Model of an Advanced Communication System for Transmitting Space Monitoring Information to the Ground Control Complex for Reception and Processing of Information

The technology of data transmission from spacecraft of remote sensing of the Earth to reception points on the ground has certain disadvantages such as the inability to quickly receive remote sens-ing data and the need to store large amounts of information on board. The technology of data re-transmission from remote sensing satellites through geostationary satellites retransmitters Luch to the reception points on the ground has the following disadvantages: the inability to quickly receive data when the remote sensing spacecraft is in the central part of the Western Hemisphere and the need for early planning of retransmission sessions. The article presents advanced concepts of com-munication organization and algorithms for establishing connections between the spacecraft and the point of data reception and transmission via a geostationary satellite repeater. The concepts are based on the following modern technologies: the availability of inter-satellite communication lines between geostationary satellites retransmitters that transforms this segment of communication net-work into a transport digital network for data transmission; the application of network technology for data flow routing that enables data transmission in an automatic mode; the application of auto-matic technology for establishing connections between remote sensing satellites and geostationary satellites retransmitters that transforms the ground reception point into a subscriber of the transport digital network by analogy with mobile network.

Structure of the emission field of ensemble of ultra-wideband chaotic sources

The structure of the emission field of ensemble of independent ultra-wideband chaotic sources in collective emission mode is investigated analytically and numerically, including power density, directivity, and far zone border. The waves emitted by independent individual sources are incoherent; hence in the reception point the created incoherent fields are summed by power, and this summation gives no additional directivity to the ensemble emission pattern. If all the individual antennas are equal, emission pattern of the entire ensemble is the same as the emission pattern of any of the individual emitters.

Urban sound energy reduction by means of sound barriers

In urban environment, various heating ventilation and air conditioning appliances designed to maintain indoor comfort become urban acoustic pollution vectors due to the sound energy produced by these equipment. The acoustic barriers are the recommended method for the sound energy reduction in urban environment. The current sizing method of these acoustic barriers is too difficult and it is not practical for any 3D location of the noisy equipment and reception point. In this study we will develop based on the same method a new simplified tool for acoustic barriers sizing, maintaining the same precision characteristic to the classical method. Abacuses for acoustic barriers sizing are built that can be used for different 3D locations of the source and the reception points, for several frequencies and several acoustic barrier heights. The study case presented in the article represents a confirmation for the rapidity and ease of use of these abacuses in the design of the acoustic barriers.