The registration period for Class II medical devices with the Indonesian Ministry of Health (MOH) through BPOM typically lasts for 5 years from the date of approval.

Class II medical device registration with the Indonesian Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), refers to the process of obtaining approval to market and distribute moderate-risk medical devices in Indonesia. The registration ensures that the device complies with Indonesian regulatory requirements for safety, effectiveness, and quality before it can be legally sold and used in the country.

Confirm Device Class: Ensure that your device is correctly classified as a Class II medical device. Class II devices generally present moderate risks and may require additional documentation, such as clinical evaluations or performance testing.

Applying for Class II medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) involves a systematic process designed to ensure that the medical device complies with Indonesian regulations.

Handling the Class II medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) involves a series of steps, from preparing your documentation to maintaining compliance with Indonesian regulations after approval.

The review timeline for Class II medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) typically takes about 3 to 6 months, depending on the complexity of the device and the completeness of the application. However, this can vary based on several factors, such as the accuracy of your submission, the need for additional information, or inspections.

The registration process for Class II medical devices in Indonesia is governed by the Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control). This process ensures that medical devices placed on the Indonesian market are safe, effective, and comply with local regulations. Below is an overview of the registration process and steps for Class II medical devices.

For regular updates and maintenance of a Class II medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control), it is essential to adhere to certain standards and processes. Regular updates ensure that the device continues to meet regulatory requirements and remains compliant with any changes in local laws, standards, and safety requirements. Below is a detailed guide on the standards and processes for maintaining your Class II medical device registration in Indonesia.