The high number of imported medical devices in health services in Indonesia must be anticipated with policies that regulate medical device spending at government health service facilities. In addition, it is also necessary to increase the use of domestic medical devices based on applied research and utilization of domestic resources, to support the strengthening of the competitiveness of the domestic medical device industry.

Located at the Novotel Bogor Golf Resort and Convention Center Hotel, the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Production and Distribution of Medical Devices held a meeting "Discussion of Policies and Technicalities in the Field of Pre-Marketing of Medical Devices and PKRT" on 25-27 July 2022.

In his report, Director of Production and Distribution of Medical Devices Sodikin Sadek said that the meeting, which was attended by 134 participants, was held as a form of support from the Ministry of Health for the production of domestic medical devices and efforts to increase the use of domestic medical devices with the aim of building the independence of the medical device industry.

"This activity is held to socialize programs and policies related to the purchase and use of domestic medical devices, as well as a means to introduce domestic medical devices to stakeholders in the hope of increasing the marketing of domestic medical devices which are currently able to compete with imported medical devices," said Sodikin.

Based on medical device transaction data in the 2019-2020 LKPP e-catalogue and regalkes system data, of the 19 types of medical devices that are widely transacted by volume and value, 16 types can be produced domestically and 3 types are still imported. The data indicates that the types of medical devices needed can be fulfilled domestically. The number of manufacturers and distribution licenses for these types of medical devices has also increased along with the needs in health services.

Director General of Pharmaceuticals and Medical Devices, Lucia Rizka Andalucia in her remarks said that the Ministry of Health has made policies to encourage pharmaceutical and medical device resilience, including the substitution of imported products. "The guarantee of domestic medical device supply needs to be a concern because hospitals need certainty to be able to buy domestic medical device products and whether the products are available in the e-catalogue," Rizka continued.

Before the sectoral catalog, the authority to freeze and unfreeze medical devices was at LKPP, after the sectoral catalog, the authority is at the Ministry of Health. "If domestic products can meet national needs, then freeze imported medical device products will be carried out," said Rizka.

Rizka further said that Indonesia has followed ASEAN harmonization in the field of medical devices and ASEAN Medical Device Directives (AMDD) regulations. Indonesia is also an active member of APEC, WHO-SEARN, and actively participates in GHWP. Thus, the requirements and standards of medical device regulation in Indonesia have followed global practice.

Currently, it should be noted that Law Number 33 of 2014 concerning Halal Product Guarantee states that products that enter, circulate and are traded in the territory of Indonesia must be halal certified which is implemented by Government Regulation Number 39 of 2021 concerning the Implementation of the Halal Product Guarantee Field, one of which is used goods originating from and / or containing animal elements including medical devices and PKRT. In this government regulation, it is also regulated regarding the staging time of halal certification obligations for medical devices and household health supply products.

The Director General of Pharmaceuticals advised that to support the optimization of the use of safe, useful and quality medical device products, collaboration and synergism between the central, provincial and district / city governments, health facilities, academics, business actors and the community are needed. Through this activity, appreciation was given to hospitals that made the most purchases of domestic medical devices for the period January 1, 2022 to July 20, 2022, namely Dr. M. Goenawan Partowidigdo Lung Hospital and Prof. Dr. R. D. Kandou Manado General Hospital as representatives of vertical hospitals, and Morowali Regional Hospital as a representative of RSUD.