INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
Medical Devices The wholesale of medical devices is subject to authorisation from the MOH. Companies must obtain a Good Distribution Practice for Medical Devices ( Cara Distribusi Alat Kesehatan yang Baik , or CDAKB) certificate and a distribution licence from the MOH. The process to obtain a CDAKB certificate and a distribution licence from the MOH is conducted online through the RBA OSS system and the MOH’s electronic sys- tem. The CDAKB certificate and the distribution licence authorises the company to conduct the wholesale of medical devices pursuant to their KBLI. The period of validity of both the CDAKB certificate and the distribution licence is five years and can be extended. 6.2 Different Classifications Applicable to Pharmaceuticals See 1.3 Different Categories of Pharmaceuti - cals and Medical Devices . 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The import and export of pharmaceuticals and medical devices in Indonesia are primarily over- seen by the Minister of Trade (MOT), the MOH, and the BPOM. The primary regulation for imports is the MOT Regulation No 36 of 2023 on Import Policy and Provisions, as lastly amended by MOT Regula- tion No 8 of 2024( “MOT 36/2023 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 last- ly amended by MOT Regulation No 21 of 2024. In the health sector, the MOH and the BPOM play crucial roles in applying and enforcing the import regulations of pharmaceuticals and medi- cal devices. For instance, the BPOM is respon- sible for issuing marketing 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 collaborates with the MOT, the MOH, and the BPOM to inspect and verify the compliance of imported pharmaceuticals and medical devic- es with all relevant regulations. After entry, the BPOM and the MOH continue to monitor and enforce compliance through routine inspections and market surveillance. 7.2 Importer of Record of Pharmaceuticals and Medical Devices Any legal entity with a valid import business licence can act as the importer of record for pharmaceuticals and medical devices. However, the import of certain products requires specific documents issued by the relevant authorities (see 7.3 Prior Authorisations for the Importa- tion of Pharmaceuticals and Medical Devices ). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices The import of pharmaceuticals and medical devices requires marketing authorisation of the products (see 3.5 Access to Pharmaceu- ticals and Medical Devices Without Marketing Authorisations ). The import of pharmaceuticals also requires an import certificate ( surat keteran- gan impor , or SKI) from the BPOM. Additionally, certain products require an import approval and/
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