Medical Device Advertising Requirements in Asia

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.

How New EU MDR Requirements Will Affect Registrations in Asia

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.

Indonesia Revamps eCatalogue Procurement System

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.

Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue

On July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,

What is CSDT Documentation?

Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”

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 to Permit Some Class A Products to Register via Notification

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 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.

COVID Test Kits Now Require In-Country Testing in the Philippines and Indonesia

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.

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.