Medical Devices means any instruments, apparatus, machines and/or implants that do not contain drugs used to prevent, diagnose, cure and relieve any diseases, treat sick person, recover human health, and/or form the structure , and improve, body functions. The purpose of the Indonesian regulatory system is to provide health protection to the public, evaluate the safety, quality, and efficacy/performance of medical devices. To facilitate innovative access of technology to the market must be in line with global standards and practices such as AMDD, IMDRF, APEC, AHWP. The aim of the Indonesian regulatory system is to make good registration management such as good submission practice & good review practice. good submission practice & good review practice.

The Ministry of Health (KEMENKES) is the health authority that handles medical devices in Indonesia. Some regulations related to pre-market dan post-market As follows:

• 62/2017 Concerning Regulation of Circulation Permit of Medical Devices, In Vitro Diagnostic Medical Devices and Household Health Supplies.

• 63/2017 Concerning Supervision of the Import Trading System of Medical Devices, In Vitro Diagnostic Medical Devices and Household Health Equipment.

• 26/2018 Concerning Integrated Electronic Business Licensing Services for the Health Sector.

The companie that wants to enter the medical device market in Indonesia must follow the regulations issued by the Ministry of Health (KEMENKES). To register Medical Devices in Indonesia, all medical devices, IVD and household health equipment (PKRT) must obtain OSS access at first in order to access the online registration portal (regalkes). Online Single Submission (OSS) is an electronically integrated business licensing system managed by the OSS Institution (Ministry of Investment/BKPM). The companie that already have IDAK/IPAK/SDAK (distribution license of medical devices) can move forward to register medical mevices to the Ministry of Health. The Ministry of Health (KEMENKES) will issue a product approval (NIE) according to the risk class of the medical device. Registrants only have 7 calendar days to process goverment fees.

The Ministry of Health (KEMENKES) normaly requests additional document, this means that if any uncompleted document provided by applicant or the MoH requests another document that must be completed before 10 calender days. After the documents are complete, the Ministry of Health will re-evaluate the application. Product approval will be issued when all documents are approved and if not, then the application will be rejected.

In accordance with PMK 62/2017 article 13, that each of type of medical device, in vitro diagnostic medical device, and household health supplies (PKRT) imported into Indonesia with one trade name/brand originating from the manufacturer can only be hold by one local distributor/ license holder.

Indonesia has three categories in the main product classification:

1. Medical Devices are instruments, apparatus, machines and/or implants that do not contain drugs that are used to prevent, diagnose, cure and alleviate disease, treat sick people, restore health to humans, and/or form structures and improve body functions.

2. Medical Devices IVD In Vitro Diagnostic Medical Device is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, apparatus or system, whether used alone or in combination with other reagents, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or systems that the product owner expects to use in vitro for the examination of any specimen

3. Household Health Supplies are tools, materials, or a mixture of materials for maintenance and care for human health, which are intended for use in households and public facilities.

Medical Devices has 4 classes which are classified based on the risks posed during use, in accordance with the Asean Medical Device Directive (AMDD):

• Class A (Low risk)

• Class B (Low – moderate risk)

• Class C (Medium – high risk)

• Class D (High risk)

IVD Medical Devices are classified into 4 risk classes which are influenced by individual risk factors and Public Healthin accordance with the provisions of the Asean Medical Device Directive (AMDD):

• Class A (Low individual risk – low public health risk)

• Class B (Middle individual risk and/or low public health risk)

• Class C (High individual risk and/or middle public health risk)

• Class D (High individual risk and high public health risk)

Household Health Supplies have 3 classes which are classified based on the risks posed by the use of PKRT to users:

• Class 1 (Low risk)

• Class 2 (Moderate risk)

• Class 3 (High risk)

In Indonesia, the Surveillance Directorate of Medical Device and Household Health Supplies (PKRT) of the Ministry of Health is in charge of post-market surveillance of medical devices (MoH). Post market surveillance (PMS) must be implemented by manufacturers and their local authorized agent or importer in compliance with the ASEAN Medical Device Directive (AMDD), which went into effect on January 1st, 2015. However, each ASEAN member state is allowed to implement PMS rules as they see fit, and each nation has its own unique characteristics; please continue reading to learn more about how post-market surveillance is conducted in Indonesia.

In conducting PMS, there are several requirements in Indonesia that will be followed up by the responsible party and the police, such as sampling and testing of medical devices, Quality Management System (QMS) audits, side audits, Advertising monitoring and labeling.

Indonesia has a system to facilitate reporting when conducting post-market, namely:

• The e-Watch system is a system for monitoring or detecting medical devices that can be accessed by the public. E-Watch contains information on medical devices that can cause harm to users. The e-Watch system can also be used for reporting by producers and distribution, such as reporting Unexpected Events (KTD) and Field Safety Corrective Action (FSCA).

• The e-Report system is a system that contains products circulating in Indonesia as well as those exported and makes the complaint search tool for medical equipment and domestic health products more traceable, to facilitate product reporting, distribution, and circulation of medical devices and Household health supplies

In carrying out an unfortunate event report, it takes time for the level of side effects caused by the product to affect the reporting time, for example:

• For serious threats to public health have a maximum time of 48 hours

• For events that cause death, the time limit is at least 10 days

• For or serious deterioration in health conditions have a period of at least 10 days

• For events that possible death or serious injury if the side effects recur‎ have a maximum period of 30 days

Source:http://regalkes.kemkes.go.id/informasi_alkes/PMK_No_62.pdfhttp://regalkes.kemkes.go.id/informasi_alkes/PMK_No_63.pdfhttps://persi.or.id/wp-content/uploads/2020/11/pmk262017.pdfhttps://oss.go.id/en/panduan