INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Under Law No 5 of 1986 on the State Adminis- trative Court, as lastly amended by Law No 51 of 2009( “Law 5/1986 as amended” ), there exists a legal avenue for challenging administrative decisions. This legislation allows any party who believes that their rights have been infringed upon by a state administrative decision to file a lawsuit in the State Administrative Court ( Pen- gadilan Tata Usaha Negara , or PTUN). For a decision to be the object of a PTUN law- suit, it must meet the criteria of being concrete, individual and final. The BPOM is a govern- mental agency responsible for regulating and controlling drugs and food products, whereas the MOH is responsible for regulating and con- trolling medical devices. As such, the BPOM’s and the MOH’s decisions are considered state administrative decisions. These decisions can be challenged in the State Administrative Court, provided they meet the aforementioned criteria. To challenge a BPOM and MOH decision, the claimant must demonstrate that the decision directly affects their legal rights or interests and is flawed either procedurally or substantively. The lawsuit must be filed within 90 days from when the decision was issued or became known to the claimant. The State Administrative Court will then review the case to determine the legal- ity and justification of the decision. If the court deems the decision unlawful, it can annul the decision and order corrective actions.
• MOH Regulation No 20 of 2017 on Good Manufacturing Practices for Medical Devices and Household Health Supplies ( “MOH 20/2017” ) • MOH Regulation No 1189/MENKES/PER/ VIII/2010 Year 2010 on Production of Medi- cal Devices and Household Health Supplies as partially revoked by MOH Regulation No 26 2018 on Electronic Integrated Busi- ness Licensing Services in the Health Sector ( “MOH 1189/2010” ) and • MOH Regulation No 4 of 2014 on Good Dis- tribution Practice for Medical Devices ( “MOH 4/2014” ). Regulatory Bodies Pharmaceuticals The BPOM is the primary regulatory body responsible for the supervision and regulation of pharmaceuticals in Indonesia. The BPOM oper- ates under Presidential Regulation (PR) No 80 of 2017 on Indonesian Food and Drug Authority ( “PR 80/2017” ) and is a non-ministerial govern- ment institution tasked with overseeing drug control. Under PR 80/2017, the BPOM oper- ates under and is accountable to the President The MOH is the primary regulatory body respon- sible for the supervision and regulation of medi- cal devices in Indonesia. As part of the central government, it operates under PR No 161 of 2024 on Ministry of Health ( “PR 161/2024” ). Under PR 161/2024, the MOH formulates and enforces health policies, including those related to medical devices. through the MOH. Medical devices
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