INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
The period of validity of both the standard certificate and the CPOB certificate is five years and can be extended. Medical Devices The manufacturing of medical devices is subject to an authorisation. Companies must obtain a Good Manu- facturing Practice for Medical Devices ( Cara Pembua- tan Alat Kesehatan yang Baik , or CPAKB) certificate and a manufacturing licence. The process to obtain a CPAKB certificate and a manufacturing licence is con- ducted online. The CPAKB certificate and the manu- facturing licence authorise the company to conduct the manufacturing of medical devices pursuant to their KBLI. The period of validity of both the CPAKB certificate and manufacturing licence is five years and can be extended. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and The wholesale of pharmaceuticals is subject to authorisation from the BPOM and the MOH. Com- panies must obtain a Good Distribution Practice for Pharmaceuticals ( Cara Distribusi Obat yang Baik , or CDOB) certificate from the BPOM and a wholesaler licence from the MOH. The process to obtain a CDOB certificate is conducted online through the RBA OSS system and the BPOM electronic system, whereas the process to obtain a wholesaler licence is conducted through the RBA OSS system and the MOH electronic system. The CDOB certificate authorises the company to conduct the wholesale of pharmaceuticals pursuant to their Indonesian KBLI. The period of validity of both the CDOB certificate and the wholesaler licence is five years and can be extended. Medical Devices The wholesale of medical devices is subject to author- isation from the MOH. Companies must obtain a Good Distribution Practice for Medical Devices ( Cara Distri- busi Alat Kesehatan yang Baik , or CDAKB) certificate and a distribution licence from the MOH. The pro- cess to obtain a CDAKB certificate and a distribution Medical Devices Pharmaceuticals
licence from the MOH is conducted online through the RBA OSS system and the MOH’s electronic system. The CDAKB certificate and the distribution licence authorise the company to conduct the wholesale of medical devices pursuant to their KBLI. The period of validity of both the CDAKB certificate and the distribu- tion licence is five years and can be extended. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Different Categories of Pharmaceuticals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The import and export of pharmaceuticals and medi- cal devices in Indonesia are primarily overseen by the Minister of Trade (MOT), the MOH, and the BPOM. The primary regulation for imports is the MOT Regula- tion No 16 of 2025 on Import Policy and Provisions, as lastly amended by MOT Regulation No 37 of 2025 (“MOT 16/2025 as amended”), which outlines the requirements and procedures for importing goods into Indonesia. For exports, the primary regulation is MOT Regulation No 23 of 2023 on Export Policy and Provisions, as lastly amended by MOT Regulation No 9 of 2025. In the health sector, the MOH and the BPOM play cru- cial roles in applying and enforcing the import regu- lations of pharmaceuticals and medical devices. For instance, the BPOM is responsible for issuing market- ing authorisations for pharmaceuticals and oversees the adherence to these authorisations at the point of entry and beyond. At the point of entry, the Indonesian customs col- laborates with the MOT, the MOH, and the BPOM to inspect and verify the compliance of imported phar- maceuticals and medical devices with all relevant reg- ulations. After entry, the BPOM and the MOH continue to monitor and enforce compliance through routine inspections and market surveillance.
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