To apply for B-class medical device registration in Indonesia, you must go through the Indonesian Food and Drug Authority (BPOM) under the Ministry of Health (MOH). The application process is primarily handled through BPOM's e-Registration portal.

Steps to Apply for B-Class Medical Device Registration in Indonesia (MOH)

1. Determine Device Classification

Before applying, confirm that your device qualifies as a B-class medical device according to BPOM's classification system. B-class devices are typically those that are moderate risk to patient health and usually require standard safety and performance data.

2. Appoint a Local Authorized Representative (for Foreign Manufacturers)

If you are a foreign manufacturer, you must appoint a local authorized representative in Indonesia. The representative will be responsible for submitting the application and interacting with BPOM on your behalf. The authorized representative must be a legal entity registered with BPOM.

3. Prepare Required Documents

Gather all the necessary documents for the registration. This includes:

• Device Information: Product description, intended use, and classification.
• Manufacturing License: Certificate from the regulatory authority in the country where the device is produced.
• Free Sale Certificate (FSC): Proving that the device is legally sold in the country of origin.
• Clinical Data (if applicable): For some B-class devices, you may need to provide clinical data or a clinical evaluation report.
• Risk Management Report: Risk analysis and safety evaluation.
• Product Labeling and Instructions for Use: Labels and IFUs in Bahasa Indonesia (Indonesian language).
• ISO Certifications (if applicable): Proof of compliance with ISO 13485 or other relevant standards.

4. Register Through BPOM’s e-Registration Portal

BPOM’s registration process is conducted through an online system called e-Registration. To apply for a B-class medical device registration:

1. Access the BPOM e-Registration Portal:

   • Visit the BPOM e-Registration portal: https://eservice.pom.go.id

2. Create an Account:

   • If you don’t already have one, you’ll need to register for an account on the portal. You will need to provide company details (for local representatives) or manufacturer details.

3. Fill Out the Registration Application:

   • Complete the application form with information about the medical device, its intended use, risk classification, and other product details.

4. Upload Required Documents:

   • Upload scanned copies of the required documentation, such as:
     • Free Sale Certificate (FSC)
     • Manufacturing License
     • Clinical Data (if applicable)
     • Product labeling (with translations in Bahasa Indonesia)
     • ISO certifications (if applicable)
     • Risk Management documentation

5. Pay Registration Fees:

   • Pay the registration fees via the e-Registration system. BPOM provides the fee structure on their portal.

6. Submit the Application:

   • Once everything is filled out and documents uploaded, submit the application for BPOM’s review.

5. BPOM’s Review and Evaluation

• After submission, BPOM will review your application and documents. The BPOM team will verify the compliance of your device with Indonesian regulations, focusing on safety, performance, and quality.
• If required, BPOM may ask for additional information or documentation during the evaluation process.

6. Additional Testing or Inspection (if required)

• Depending on the nature of the device, BPOM may request local testing, clinical data, or even an inspection of the manufacturing facility.

7. Receive Approval and Registration Certificate (Surat Izin Edar)

• If everything is in order, BPOM will approve the registration and issue a Surat Izin Edar (SIE), which is the official registration certificate that authorizes the device for sale in Indonesia.

8. Post-Market Surveillance

• Once registered, you are responsible for adhering to post-market surveillance requirements. This includes monitoring the device’s performance, reporting any adverse events, and ensuring compliance with ongoing regulatory requirements.

Where to Apply: BPOM’s e-Registration Portal

You must apply for B-class medical device registration through the official BPOM e-Registration portal.

BPOM e-Registration Portal Link:

• e-Registration Portal: https://eservice.pom.go.id

Contact BPOM for Assistance:

If you need assistance or have questions about the application process, BPOM provides contact details and support through their official website.

• BPOM Official Website: www.pom.go.id