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There is a clear increase of enforcement actions taken by health authorities, both at the Federal and State level, where authorities are verifying if both physician and dining rooms at manufacturing plants, from all industries, have been properly supported by the applicable Notices of Operation. At the same time, many local health authorities are unduly requesting companies to have a Notice of Operation for their manufacturing operations. Companies shall comply the former and be prepared to reject the latter in order to prevent disruptions of operations and future sanctions. 

With Judgment No. 5063 of 17 August 2020, in line with the most recent case law, the Council of State confirmed that the equivalence criterion applies in the award of tenders for the supply of medical devices. According to said criterion, the assessment of bids with respect to the relevant technical specifications must be grounded on criteria of substantial conformity of the offered technical solutions and not to formalistic findings.

The Indonesian Financial Services Authority (OJK) has issued OJK Regulation No. 44 of 2020 on Risk Management for Non-Bank Financial Institutions. Non-bank financial institutions under this regulation include insurance companies, pension funds and financing companies. This regulation replaces OJK Regulation No. 1 of 2015 on the same subject matter. This regulation has already come into effect.

In this publication, we focus on the impact of the regulation on insurance companies and insurance intermediary companies. For the purpose of this publication, ‘insurance companies’ also refers to insurance intermediary companies.