A list of recently published and updated articles regarding medical device regulatory updates from the MOH and other governing bodies in Indonesia.

Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices

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.

Indonesia Market Summary and Registered Devices Review

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.

Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories

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.

MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMIC

COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.

INDONESIA E-CATALOGUE MEDICAL DEVICE ENROLLMENT 2020

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.

INDONESIA CALLS FOR NEW ROUND OF E-CATALOGUE APPLICANTS

In response to the overwhelming interest to a June invitation for registered medical device license holder to request inclusion of their device/s in the 2019 e-Catalogue enrollment, the Indonesia Ministry of Health (MOH) has extended the application deadline.

Indonesia Tightens Enforcement of Medical Device Licensing

With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.

INDONESIA E-CATALOGUE ENROLLMENT DEADLINE JUNE/JULY 2019

The Indonesian government procurement agency, known as LKPP, has invited medical device companies to apply for any existing e-Catalogue contract extensions by July of 2019