The Compliance of Medical Equipment Design Technology against Indonesian Medical Regulatory Board

Abstract

The government policy on Indonesian National Health program demands adequate supply of medical devices in terms of the number and type of equipment. Currently, there are about 90% of the medical devices are obtained through imports and 10% are sourced locally. In 2035, the Health Ministry has projected to reduce their dependency to imported devices up to 35% through a localization program which to be accelerated by domestic industry. During the implementation effort, the progress is rather slow due to technology limitation coupled with acute shortage of expertise in the area of medical device products. This technology is scarce but it is a foothold for the development of safe and effective as intended use and shorter time to market. In this study the medical device’s design technologies are examined to established the regulatory requirement and specifications. A paper review on medical devices technology and regulatory were done to formulate a systematic approach to identify the design requirement to meet the required standards. The main requirements are functionality, usability, safety and conformity against standards.