INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
Medical Devices Applications to obtain marketing authorisa- tions for medical devices and in vitro diagnostic medical devices are submitted online through the RBA OSS system and the MOH electronic system. The application includes submission of administrative and technical requirements, including a certificate of production/medical device distribution licence, certificate of free sale, quality management system document, and product information. The MOH then evaluates and verifies the admin- istrative and technical requirements of the appli- cation. If the medical devices involve new tech- nology, active substances, or uncommon claims, a review by a designated expert team may be required. If the administrative and technical requirements are fulfilled and the documents are complete, the marketing authorisation is issued electroni- cally within a specified timeframe. Otherwise, the MOH will issue a refusal letter. If additional information is required, the MOH will notify the applicant to provide the necessary details or documents. Variation in the marketing authorisation must be conducted in the event there is a variation in: • the size, packaging or marking of the product; • accessories/attachments to the marketing authorisation; or • the name or address of the representative authorised by the manufacturer. If there are variations other than the foregoing, the marketing authorisation holder must apply for a new marketing authorisation.
Applications for a variation in the marketing authorisation for medical devices are submitted online through the MOH electronic system and fulfil administrative and technical requirements. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations In principle, medical devices and in vitro diag- nostic medical devices that are produced, imported, assembled, and/or repackaged must have a marketing authorisation to be distributed within Indonesia. However, MOH 62/2017 pro- vides specific exemptions to this requirement: • medical devices that enter Indonesia through a special access scheme (SAS) in accordance with laws and regulations; • certain medical devices and in vitro diagnos- tic medical devices produced by household companies; and/or • medical devices and in vitro diagnostic medi- cal devices for certain reasons determined by the MOH. Pharmaceuticals that enter Indonesia through the SAS in accordance with laws and regula- tions are exempted from the requirement for a marketing authorisation. In the event of a public health emergency, the marketing authorisation may be in the form of an emergency use authori- sation (EUA), which is only effective for use of drugs during the public health emergency and for patient medications in accordance with laws and regulations. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations Pharmaceuticals A holder of a marketing authorisation for phar- maceuticals is required to submit production
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