August 13, 2018

In connection with the stipulation of Government Regulation No. 24 of 2018 on Electronic Integrated Licensing Service or commonly named as OSS (Online Single Submission), the Ministry of Health of R.O.Indonesia stipulates Republic of Indonesia Ministry Regulation number 26 of 2018, to regulate the acceleration and increase ininvestment and strive in the Healthcare sector,. This has been enacted since July 12, 2018. As for matters regulated in this rule, they are as following:

a.      type of Business Licensing the health sector;

b.      requirements;

c.      the procedures for issuing permits;

d.      the validity period of the license; and

e.      supervision.

In this regulation, there are 33 types of business licensing, which are regulated in the healthcare sector. Some of them are Medical Device distributor license (for Branch Office), In Vitro Diagnostic Medical Device and PKRT (Household Health Supplies) licenses for New Innovation and Development Medical Device and PKRT locally produced Indonesia.

By using this OSS system, companies can get all the necessary licenses through one online platform. It is no longer required for these companies to go to related authorities to get their necessary licenses. They only need to register via the OSS and submit the required documents through this online system and get the necessary license.