INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
3.7 Third-Party Access to Pending Applications for Marketing Authorisations Information relating to pending applications for mar- keting authorisations both for pharmaceuticals and medical devices is not made available to, and thus cannot be accessed by, third parties. Specifically with regard to pharmaceuticals, Article 27 (4) of H.BPOM 24/2017 as amended provides that any information submitted to the BPOM for the purpose of applying for marketing authorisation is strictly confidential and may only be used solely for evaluation purposes by authorised parties. The BPOM provides a website where third parties can access information concerning the status of market- ing authorisations (ie, whether the said authorisation is active, suspended, or has been revoked). Article 1 (9) of BPOM 8/2024 and Article 1 (6) of MOH 63/2017 affirm that the confidentiality of information relating to individuals participating in clinical trials of pharmaceuticals and medical devices is an integral part of the Good Clinical Practice standard, which must be adhered to when conducting clinical trials. Additionally, the Appendix to BPOM 8/2024 and the Appendix to MOH 63/2017 further clarify that clinical trials must keep confidential all information relating to individuals participating in clinical trials. Researchers may also be instructed to maintain the confidential- ity of any information relating to pharmaceuticals and medical devices. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes Medical Devices In Indonesia, there is no fast-track registration route for medical devices. The registration process must adhere to the procedures set forth by MOH 62/2017 and MOH 11/2025. MOH 11/2025 requires all devices to undergo evaluation based on their risk classification (Class A, B, C, or D), with corresponding timelines and requirements.
marking and information. The marking and informa- tion are prohibited from including certain contents – for example, using superlative words such as “very”, “top” and “super” and mentioning the name of the test lab. Holders of a marketing authorisation must submit reports, including production reports or distribu- tion reports, to the MOH. They must also submit an adverse event report if an adverse event occurs. Manufacturers and distributors of medical devices and in vitro diagnostic medical devices must super- vise their products and ensure conformity to stand- ards of quality, safety, and usefulness. The supervi- sion can take the form of an audit, re-examination of products to determine serious adverse events, and reporting serious adverse events to the government. Further, MOH 11/2025 also provides that a holder of a medical device marketing authorisation shall, among other things: • take responsibility for every medical device cov- ered by the issued marketing authorisation; • submit periodic and event-driven reports via the National Health Information System (including distribution reporting, reporting of adverse events, and reporting any potential supply shortages); • ensure each authorised product has a Pharmaceu- tical and Medical Device Dictionary ( Kamus Far- masi dan Alat Kesehatan or KFA) code; • for software-based medical devices (including those with AI/ML features), comply with speci- fied ethics and “Good Machine Learning Practice” principles and implement data governance and cybersecurity measures, including privacy/secu- rity, transparency/accountability, cloud security, data minimisation, retention/deletion, and incident/ breach reporting; and • where relevant, meet telecom certification require- ments, and follow MOH rules on stock run-down and relabelling/re-stickering approvals in situations such as labelling changes or agency/distributor transitions.
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