A list of recently published and updated articles regarding medical device regulatory updates from the MOH and other governing bodies in Indonesia.
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 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 will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
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.
In recent years, the government has made healthcare a priority for the 261 million Indonesians, providing a lot of potential for medical device manufacturers of all technology levels. The government has also taken numerous steps to curb corruption through their online e-catalogue and other methods which has helped bring in more foreign companies and investment.
The Indonesia Ministry of Health recently announced that they will be opening the e-catalogue enrollment period and will soon begin accepting applications for 1,480 product categories.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
Medical device manufacturers are advised to prepare e-Catalogue applications early and be vigilant for the enrollment announcement. Implementing an optimal pricing strategy will be critical to successful public hospital sales. The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is little room for regional dealer margin under the price scheme.
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