To apply for Class II medical device registration with the Indonesian Ministry of Health (MOH), you will need to submit your application to the National Agency of Drug and Food Control (BPOM), which is the regulatory body responsible for overseeing the registration and approval of medical devices in Indonesia.

Here are the steps and platforms where you can apply for Class II medical device registration in Indonesia:

1. BPOM's Online Registration System

• BPOM operates an online registration system where manufacturers, authorized representatives (ARs), and importers can submit their application for medical device registration. The system is known as the e-registration platform for medical devices.
• Website: You can access the registration system through BPOM’s official website:
  • BPOM Website: www.pom.go.id
  • The online system allows you to submit your registration documents, track the status of your application, and communicate with BPOM.

2. Manual Application Submission (If Required)

• In some cases, BPOM may require or allow for manual submission of the application, particularly if there are issues with the e-registration system or if the device requires additional review.
• Applications can be submitted at the BPOM office in Jakarta or to the designated regional BPOM office, depending on the specific device category.
  • BPOM Headquarters:
    Badan Pengawas Obat dan Makanan (BPOM)
    Jalan Percetakan Negara No. 23
    Jakarta Pusat, Indonesia
• It is advisable to check with BPOM or a local representative to determine if manual submission is required.

3. Role of Local Authorized Representative (AR)

• If you are a foreign manufacturer, you must have a local authorized representative (AR) or an importer in Indonesia. The AR will act as your liaison with BPOM and handle the submission process on your behalf.
• The AR will submit the application documents on your behalf through the BPOM e-registration system or manual submission, depending on the situation.

4. Submission Process

The application process involves the following steps:

1. Prepare Documentation: Ensure all required documents (such as product description, certificate of free sale, clinical evaluation report, ISO certification, etc.) are ready and, where necessary, translated into Bahasa Indonesia.
2. Register Online: Log in to the BPOM e-registration system and submit your application along with the required documents. You will need to create an account on the platform if you haven’t done so already.
3. Payment: Pay any associated registration fees as instructed by BPOM.
4. Document Review: BPOM will review your application and, if necessary, request additional information.
5. Approval and Registration: Upon successful review, BPOM will issue the Registration Certificate (Surat Tanda Pendaftaran, STP), which will allow you to market your device in Indonesia.

5. Important Notes

• Local Representative Requirement: Foreign manufacturers must have a local representative to submit the application and communicate with BPOM. This representative is responsible for handling all regulatory communications.
• Communication and Follow-Up: Regular follow-up and communication with BPOM may be necessary, especially if additional information or clarification is required during the review process.
• BPOM Helpdesk: If you encounter any issues or need guidance, BPOM provides a helpdesk for technical support and inquiries related to registration.

For Class II medical devices, the process typically takes 3 to 6 months, depending on the completeness of your application and BPOM’s workload.

Would you like more details on how to navigate the e-registration system or how to work with a local representative?