A list of recently published and updated articles regarding medical device regulatory updates from the MOH and other governing bodies in Indonesia.
On May 6th, 2024 the President of Indonesia, Joko Widodo launched the new hospital-based Specialist Doctor Education Program which supports Indonesia’s growing commitment to the healthcare industry and provides strong support for investment in Indonesia.
On April 30th, 2024, the Ministry of Health in Indonesia announced that it will be implementing a Good Distribution Practice of Medical Devices (GDPMD) requirement.
Recent developments have made the Indonesian market an even more attractive place to generate medical device sales growth.
April 23rd to 27th, 2024, Asia Actual Indonesia hosts Asia Actual USA, Singapore, China, Vietnam, Philippines, and Thailand, for a Summit.
Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”
On January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately.
Indonesia’s Ministry of Health announced that as of September 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.
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
On April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.
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