INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
Medical Devices Indonesia does not embrace the notion of regu- latory reliance for the medical device authori- sation process. Consequently, despite having obtained authorisations in a country with a well- established evaluation system, all products and establishments must still undergo local authori- sation processes in adherence to MOH 62/2017. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Pharmaceuticals The manufacturing of pharmaceuticals is sub- ject 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) cer- tificate from the BPOM. The process to obtain both authorisations is conducted online through the RBA OSS system. For the standard certifi- cate application, the RBA OSS system will then redirect to the MOI electronic system. For the CPOB certificate application, the RBA OSS sys- tem will redirect to the BPOM electronic system. The standard certificate and the CPOB certifi- cate authorise the company to conduct manu- facturing of pharmaceuticals pursuant to their Indonesian Business Classification Code ( Klasi- fikasi Baku Lapangan Usaha Indonesia , or KBLI). The period of validity of both the standard certifi- cate and the CPOB certificate is five years and can be extended.
Medical Devices The manufacturing of medical devices is sub- ject to an authorisation. Companies must obtain a Good Manufacturing Practice for Medical Devices ( Cara Pembuatan Alat Kesehatan yang Baik , or CPAKB) certificate and a manufacturing licence. The process to obtain a CPAKB certifi- cate and a manufacturing licence is conducted online. The CPAKB certificate and the manufac- turing 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. Companies 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 con- ducted through the RBA OSS system and the MOH electronic system. The CDOB certificate authorises the company to conduct the whole- sale of pharmaceuticals pursuant to their Indo- nesian KBLI. The period of validity of both the CDOB certificate and the wholesaler licence is five years and can be extended. Medical Devices Pharmaceuticals
160 CHAMBERS.COM
Powered by FlippingBook