A list of recently published and updated articles regarding medical device regulatory updates from the MOH and other governing bodies in Indonesia.
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.
On February 11th and 14th, the Ministry of Health of the Republic of Indonesia implemented significant structural and procedural changes to the government procurement system known as e-Catalogue as it applies to medical devices (reference announcement KN.01.04/3/630/2022). Under the new rules, oversight of the e-Catalogue has been moved under the Ministry of Health and will not require negotiations.
On July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,
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.
In 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country.
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.
At this time Indonesia’s Ministry of Health will only regulation Rapid Diagnostic Tests (RDTs) while the Philippines Department of Health will require testing for RDTs, along with other related products such as Nucleic Acid Extraction Kits and COVID-19 antibody tests. It’s expected that the process will require 1-2 months in each country.
Per Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring products with a Domestic Component Level (TKDN) and Benefit Weigh Value (BMP) of 40% or more be purchased by government hospitals regardless of available foreign products.
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