The procedures for applying for Class A medical device registration with Indonesia's Ministry of Health (MOH) involve a series of steps to ensure compliance with local regulatory requirements. These procedures are designed to confirm that the medical device is safe and effective for use in Indonesia, even for low-risk devices like Class A. Below is a step-by-step guide for applying for Class A medical device registration with the Indonesian Ministry of Health (MOH).

To process Class A medical device registration with Indonesia’s Ministry of Health (MOH), you need to follow a series of steps to ensure compliance with local regulatory requirements. Class A medical devices are considered low-risk and typically have a simpler registration process compared to higher-risk devices. Below is a step-by-step guide to processing Class A medical device registration with the Indonesian Ministry of Health (MOH).

The process for registering a Class A medical device with Indonesia’s Ministry of Health (MOH) typically takes 2 to 4 months. The duration may vary depending on the completeness and accuracy of the application, as well as the workload of the regulatory authorities. Class A devices are considered low-risk, so their review process is generally faster compared to higher-risk medical devices.

The process for Class A medical device registration with Indonesia's Ministry of Health (MOH) involves several steps to ensure the device meets safety, quality, and regulatory standards. Class A medical devices are considered low-risk devices and have the simplest registration process compared to higher-risk devices (Class B, C, or D).

Periodic updates and renewals of Class A medical device registration with Indonesia’s Ministry of Health (MOH) are essential for maintaining compliance with Indonesian regulations and ensuring that your product continues to meet safety, performance, and quality requirements. The process for updating or renewing the registration is outlined in various regulatory frameworks, including Regulation No. 62/2017 on Medical Device Distribution and BPOM (Indonesian National Agency of Drug and Food Control) guidelines.

After obtaining Class A medical device registration with Indonesia’s Ministry of Health (MOH), manufacturers and distributors must adhere to a range of regulatory requirements and obligations to ensure ongoing compliance with Indonesian medical device laws. These regulations help ensure that medical devices are safe, effective, and remain compliant throughout their lifecycle in the market.

Class A Classification: Verify that your device qualifies as a Class A medical device under Indonesian regulations. Class A devices are low-risk devices, and it’s essential to confirm this classification to ensure you follow the correct regulatory path.

After obtaining Class A medical device registration with Indonesia's Ministry of Health (MOH), there are several important actions and considerations to ensure continued compliance with regulations, successful market entry, and smooth distribution of your product in Indonesia.