To apply for B-class medical device registration with the Indonesian Ministry of Health (MOH), you need to follow these general steps:

1. Prepare Required Documentation

You will need to gather and prepare the necessary documents, which include:

• Product information: Detailed description of the medical device, including its intended use, materials, and features.
• Manufacturing license or certificate (if applicable).
• Free sale certificate from the country of origin, confirming that the product is legally sold in that market.
• Clinical evaluation or performance data (if applicable).
• Labeling and instructions for use in the Indonesian language (Bahasa Indonesia).
• Risk classification documentation to justify the B-class classification.

2. Verify the Product Classification

In Indonesia, medical devices are classified into four classes: A, B, C, and D, based on the risk level. B-class devices are considered to have moderate risk. It's important to ensure that the device you're registering is accurately classified.

The Ministry of Health will review the classification based on the information you submit.

3. Engage a Local Authorized Representative (Optional but Recommended)

If you're an overseas manufacturer, you may need to appoint a local authorized representative in Indonesia who will act on your behalf for the registration process.

4. Submit the Application

• The application must be submitted to BPOM (Badan Pengawas Obat dan Makanan), the Indonesian National Agency of Drug and Food Control.
• You will need to create an account on BPOM's online system (e.g., e-registration portal) to submit the application.
• Ensure that the application is filled out correctly and that all necessary documents are attached.

5. Application Review

BPOM will review the submitted application and documentation. This process may involve:

• Technical review: Ensuring the device meets the necessary safety and performance standards.
• Administrative review: Confirming that all required documentation is complete.

6. Product Testing (if necessary)

For some B-class devices, BPOM may require testing or certification from an accredited testing laboratory in Indonesia or internationally. This is particularly true for devices that require validation of safety or effectiveness.

7. Approval and Issuance of Registration

Once BPOM approves the application, they will issue a Registration Certificate (Surat Izin Edar / SIE) for the device, allowing it to be marketed and sold in Indonesia.

8. Post-Market Surveillance

After approval, the manufacturer or authorized representative must comply with post-market surveillance requirements, including reporting adverse events, conducting regular audits, and maintaining records.

Key Considerations:

• Ensure compliance with Indonesian language requirements for labeling and documentation.
• The registration fee varies depending on the device, so be prepared to pay this when applying.
• B-class devices generally require less rigorous documentation than higher-class devices but still require careful attention to quality standards.

You can reach out to BPOM for any additional clarifications or changes to the process, as regulations may be updated over time.