Medical Device Permission Progress

The era of digital transformation is a period that carries the application of digital technology in all aspects of life in society. A superior nation is seen in the development of Science and Technology (Science and Technology) which is characterized by many innovations in technology. Innovation is an important pillar in determining the competitiveness of a nation.

Regarding technological innovation, various studies have been conducted to find modern drugs and medical devices that still prioritize quality so that they can be well received by the public. Indonesia has special institutions to conduct standardization in granting distribution permits for health products, namely the Food and Drug Administration (POM) and the Directorate General of Health. The distribution permit will be granted when the product has fulfilled the requirements of good manufacturing practice and clinical evidence according to the indication. The Ministry of Health (MOH) issued Minister of Health Regulation (Permenkes) number 63 of 2017 on Good Clinical Trials of Medical Devices. The Permenkes states that there are two types of clinical trials, namely pre-marketing and post-marketing clinical trials.

A pre-marketing clinical trial is a clinical trial using a test product that has not been authorized for marketing in Indonesia, including a clinical trial with a test product that has been authorized for a new indication or intended use. Meanwhile, post-marketing clinical trials are clinical trials using test products that have undergone pre-marketing clinical trials and have been licensed in Indonesia to obtain data on benefits, safety or to confirm approved performance. The existence of the Permenkes is expected to overcome the obstacles associated with clinical trials of medical devices. So that Indonesia is able to produce research-based medical devices and make Indonesia one of the research-based medical device producers that should be taken into account by the world.

The potential development of medical device manufacturers must be in line with the improvement of national medical device product technology. The number of domestic medical device industries at the beginning of 2018 has increased by 25.3%, namely 27 industries. So that currently there are 242 industries with 294 types of medical devices produced.

It is hoped that the development of the domestic medical device industry can produce safe, quality and useful products. So that the work of the nation’s children can be widely utilised by the community towards the independence of medical devices in Indonesia.