INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
als must keep confidential all information relat- ing to individuals participating in clinical trials. Researchers may also be instructed to maintain the confidentiality 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 pro- cess must adhere to the procedures set forth by MOH 62/2017. The regulation requires all devices to undergo evaluation based on their risk classification (Class A, B, C, or D), with cor- responding timelines and requirements. For domestically produced devices, the evalua- tion timelines are as follows: • Class A (low risk) – maximum ten days; • Class B (low-to-moderate risk) – maximum 20 days; • Class C (moderate-to-high risk) – maximum 20 days; and • Class D (high risk) – maximum 30 days. For imported devices, the evaluation timelines are as follows: • Class A (low risk) – maximum 15 days; • Class B (low-to-moderate risk) – maximum 30 days; • Class C (moderate-to-high risk) – maximum 30 days; and • Class D (high risk) – maximum 45 days. After all administrative and technical require- ments are deemed complete and compliant,
the MOH will issue the marketing authorisation within ten days. In practice, the above timelines can be longer. Notably, during the COVID-19 pandemic, a tem- porary 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 pandemic emergency has resolved, the reg- istration process has reverted to the standard procedures outlined in MOH 62/2017. Pharmaceuticals For pharmaceuticals, although no fast track mechanism exists, the BPOM embraces the notion of regulatory reliance (see 4.2 Regulatory Reliance ), which streamlines the authorisation Indonesia has embraced the notion of regula- tory reliance to streamline its drug authorisation process. Under BPOM 24/2017, the evaluation for registration of a medicine can take 300 busi- ness 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 120 business days. This expedited time- line applies specifically to registrations of new medicines and registration of major variations with new indications or posology for biological products and new chemical drugs. process for pharmaceuticals. 4.2 Regulatory Reliance Pharmaceuticals
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