In 2010 the Indonesian Ministry of Health issued regulations relating to the production of medical devices and Household (PERMENKES 1189/VIII/2010), PERMENKES 1191/VIII/2010 concerning medical device distributors, and PERMENKES 70/2010 concerning household producer. With the latest presidential regulation, No. 91/2017 and 24/2018 related to business acceleration and integrated licensing services by electronic, the Ministry of Health issued a regulation to integrate licensing services in the health sector to accelerate the process of medical equipment licensing in Indonesia.

In Indonesia regulation before process product approval in regards for Manufacturing and Distribution company, the manufacturing license and Medical equipment distributor license should be obtained. To obtain the both licenses is required investigation from regional province (Health offices) refer the company domicile. In new regulation PMK 26/2018 the investigation is doing by central government (Ministry of Health) to accelerate the process. Furthermore, fewer requirement, the Timelines reduced, and Validity stated in Distributor license for 5 years.

There are around 33 health sectors that are under the auspices of the Ministry of Health, one of which is related to the Product Approval of Medical Device / IVD / Household, Distribution Certificate, and GDPMD (Good Distribution Practice for Medical Device) Certification.

WIth the presidential regulation related to integrated licensing services by electronic, the Indonesian government issued new system in July 2018, namely OSS (Online Single Submission), that all permits or licensing will be carried out through single window processes including medical device licensing.

There is no certainly when this regulation will be realized for all health sector but is still process to changes. In regulation 26/2018 chapter IV there are 3 heads of government who have right to issue permits including the Ministry of Health, regional governors, and regents or mayors. Especially for product approval licensing, manufacturing license, distribution license and GDPMD certification are under the Ministry of Health.