INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
4.2 Regulatory Reliance Pharmaceuticals
For domestically produced devices, the evaluation timelines are as follows: • Class A (low risk) – maximum 16 days; • Class B (low-to-moderate risk) – maximum 26 days; • Class C (moderate-to-high risk) – maximum 26 days; and • Class D (high risk) – maximum 40 days. For imported devices, the evaluation timelines are as follows: • Class A (low risk) – maximum 21 days; • Class B (low-to-moderate risk) – maximum 36 days; • Class C (moderate-to-high risk) – maximum 36 days; and • Class D (high risk) – maximum 55 days. After all administrative and technical requirements are deemed complete and compliant, the MOH will issue the marketing authorisation within ten days. In prac- tice, the above timelines can be longer. Notably, during the COVID-19 pandemic, a temporary fast-track registration process (EUA) was introduced under the COVID-19 EUA Guidelines issued by the MOH in 2021. Under the COVID-19 EUA Guidelines, the evaluation timeline for Class A, Class B and Class C would only be ten days. However, this process only applied to certain types of medical device products determined under the COVID-19 EUA Guidelines, such as N95 masks, surgeons’ gloves, oxygen masks, and portable oxygen generators. However, as the pan- demic emergency has resolved, the registration pro- cess has reverted to the standard procedures outlined in MOH 62/2017 and MOH 11/2025. Pharmaceuticals For pharmaceuticals, although no fast-track mecha- nism exists, the BPOM embraces the notion of regu- latory reliance (see 4.2 Regulatory Reliance ), which streamlines the authorisation process for pharmaceu- ticals.
Indonesia has embraced the notion of regulatory reli- ance to streamline its drug authorisation process. Under BPOM 24/2017, the evaluation for registration of a medicine can take 300 business days. However, if the medicine has been approved in at least one country with a well-established evaluation system, the evaluation for registration of such medicine can be expedited to only 90 business days. This expedit- ed timeline applies specifically to registrations of new medicines and registration of major variations with new indications or posology for biological products and new chemical drugs. Medical Devices Indonesia does not embrace the notion of regulatory reliance for the medical device authorisation process. Consequently, despite having obtained authorisations in a country with a well-established evaluation system, all products and establishments must still undergo local authorisation processes in adherence to MOH 62/2017 and MOH 11/2025. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants Pharmaceuticals The manufacturing of pharmaceuticals is subject to authorisation from the Ministry of Industry (MOI) and the BPOM. Companies must obtain a standard certificate from the MOI and a Good Manufacturing Practice for Pharmaceuticals ( Cara Pembuatan Obat yang Baik , or CPOB) certificate from the BPOM. The process to obtain both authorisations is conducted online through the RBA OSS system. For the standard certificate application, the RBA OSS system will then redirect to the MOI electronic system. For the CPOB certificate application, the RBA OSS system will redi- rect to the BPOM electronic system. The standard certificate and the CPOB certificate authorise the company to conduct manufacturing of pharmaceuti- cals pursuant to their Indonesian Business Classifica- tion Code ( Klasifikasi Baku Lapangan Usaha Indone - sia , or KBLI).
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