Based on the mandate of Law Number 36 of 2009 concerning Health, medical devices circulating in Indonesia must meet the requirements of safety, quality and usefulness, as evidenced by the ownership of a distribution license, which is a form of government protection for the public to be protected from the use of medical devices that do not meet the requirements.
In 2016, based on the President's direction, the XV Economic Policy Package was issued in the form of simplifying the export and import trade system, one of which was through shifting the supervision of the import trade system from the customs area (border) to outside the customs area (post-border) or the so-called post-border trade system supervision.
The post-border trade control policy not only has a positive impact in the form of increasing the smooth flow of goods, but also the formation of more optimal coordination / cooperation between Ministries / Institutions in monitoring imported commodities, including in this case between the Ministry of Health with the Directorate General of Customs and Excise and the National Single Window (LNSW).
The era of globalization and free trade in the ASEAN economic community increases the opportunity for imported products to enter Indonesia, including medical devices. Currently, the number of imported medical devices that have a distribution license is 87.5% and domestic medical devices are 12.5%.
In order to support the post-border trade system policy, the Ministry of Health has issued Permenkes No. 60/2017 on the Supervision of Import Trade System of Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies, and Kepmenkes No. HK 01.07/Menkes/234/2018 which regulates the division of supervision of medical devices, in vitro diagnostic medical devices and PKRT, namely 107 HS Codes in border and 81 HS Codes in post-border.
The implementation of monitoring the import and export of medical devices and PKRT certainly cannot be done alone by the Ministry of Health but requires synergy with related cross-sectors such as the Directorate General of Customs and LNSW.
In order to strengthen cooperation in the supervision of imported medical devices, the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Medical Device Supervision organizes Memorandum of Understanding (MoU) activities between the Ministry of Health (Directorate General of Pharmaceuticals and Medical Devices) and the Ministry of Finance (Directorate General of Customs and Excise and the National Single Window Institution).
In her report, the Director of Medical Device Supervision, Cut Putri Arianie, said that the preparation of this MoU had gone through a series of long processes, initial discussions since September 2021 and through intense and collaborative discussions until finalization in March 2022.
Until finally this signing activity can be carried out in the Dr. Johannes Leimena Room, Adhyatma Building, Ministry of Health on Tuesday, May 24, 2022. The signing was carried out by the Director General of Customs and Excise, Askolani; Head of the National Single Window Institution, M. Agus Rofiudin; and the Director General of Pharmaceuticals and Medical Devices, L. Rizka Andalucia, witnessed by the Secretary General of the Ministry of Health, Kunta Wibawa Dasa Nugraha.
This cooperation focuses on:
- Strengthening integrated supervision through Single Stakeholders Information (SSI) Indonesia Single Risk Management (ISRM).
- Joint handling of violations of import and/or export activities of medical devices and household health supplies.
- Harmonization of the HS Code, for the benefit of international trade in regulating goods leaving or entering Indonesia that have different taxation rates.
- Integration of information systems, in order to facilitate reports on the production and distribution of Alkes and PKRT and be able to detect complaints from product users.
- Joint follow-up and evaluation of the results of border and post-border trade control.
“With this cooperation, we hope that the commodities of medical devices circulating in Indonesia will be able to ensure that they meet the requirements and have an impact on the resilience of medical device resilience and protection of public health,” said Rizka in her speech.