The cost for registering a Class A medical device in Indonesia depends on several factors, including the type of device and specific fees set by the Ministry of Health (MOH).

A foreign manufacturer must appoint a local representative (distributor or regulatory consultant) registered with Indonesia's MOH. This representative acts as the legal license holder.

Ensure that your device qualifies as a Class A medical device (low-risk category).

Class A medical device registration is the process of obtaining official approval from Indonesia's Ministry of Health (MOH) for low-risk medical devices. These devices are classified as "Class A" based on their minimal risk to the patient or user (e.g., bandages, surgical gloves, or thermometers).

Ensure your device is classified as Class A (low-risk) according to Indonesia's classification system.

After submitting an application for Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM, there are several regulations and requirements that must be followed to ensure the successful approval and ongoing compliance of the medical device in the Indonesian market. These regulations cover both the registration process and the post-market requirements for medical devices.

Before applying for Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM, it is important to make thorough preparations to ensure that your application is complete, accurate, and compliant with Indonesian regulations. Proper preparation will help streamline the registration process and minimize delays.

Once Class I medical device registration with the Indonesia Ministry of Health (MOH) through BPOM is approved, there are several key considerations to ensure compliance with Indonesian regulations and maintain market access.