Indonesia to Require Post-Market In-Country Testing of Medical Devices

Indonesia’s Ministry of Health announced that as of September 22, 2023, certain medical devices will require post-market in-country product testing. While the Ministry of Health explained that initially there is no compulsion to carry out the testing currently, there are rewards for doing so.

Details of In-Country Testing

License holders are expected to carry out local, post-market testing of devices in Indonesia to ensure the products continue to meet defined standards of safety, quality and benefits. This testing is required at least every two years in an accredited testing laboratory and the results must be reported to the Ministry of Health Directorate of Medical Device Supervision electronically.

Benefits of In-Country Testing

Although the new testing requirement will not initially be enforced, there will be benefits to doing so. If a company decides to do in-country testing in Indonesia, the Ministry of Health will list the product on the Supervision Directorate portal and prioritize the product in the e-Katalog (AKA eCatalogue).

Issues with New Testing Rules

Indonesia’s Ministry of Health announced draft guidance on July 21, 2023, that certain medical devices would require post-market testing within Indonesia to ensure products continue to meet safety, quality and benefit requirements independently. They allowed commentary on the announcement through September 22, 2023.

While seeking input on the new regulations for in-country post-market testing, several parties brought up issues with the regulations. For instance, requiring testing every two years in-country will incur greater costs for license holders and/or manufacturers. Furthermore, many manufacturers are of the opinion that this testing should be performed by local authorities and not be a burden to the license holder.

Additionally, many distributors do not have stock in inventory to carry out testing of certain large products, such as CT scanners. Even if the manufacturer does have the required inventory, the tested products are likely to be considered “used goods”, which means they will not be able to be sold.