To apply for the registration of a Class 3 medical device with the Ministry of Health (MOH) of Indonesia, you need to follow these steps:

1. Appoint an Indonesian Authorized Representative

• If you are a foreign manufacturer, you must appoint a local authorized representative in Indonesia who will handle all communication and submission on your behalf.

2. Prepare Required Documentation

• Product Information: Include the device’s intended use, design, manufacturing process, and detailed technical specifications.
• Clinical Data: Class 3 devices typically require clinical data demonstrating safety and performance. This could include clinical trial reports or scientific literature supporting the device’s use.
• Quality Management System: Evidence of compliance with international quality standards such as ISO 13485.
• Product Labeling and Instructions for Use: Must be in Indonesian and meet the regulatory requirements.
• Risk Management: A report in line with ISO 14971 showing the device’s risk management process.
• Certificate of Free Sale (CFS): This certificate should be issued by the health authority in the country where the device is manufactured, showing that the device is legally sold in that country.
• Declaration of Conformity: From the manufacturer, affirming that the device meets all relevant regulatory requirements.

3. Prepare the Registration Dossier

• Assemble the technical dossier as per the guidelines provided by the Indonesian Food and Drug Authority (BPOM) and the MOH. This may include:
  • Product description
  • Design and manufacturing details
  • Risk management documentation
  • Clinical trial data (if applicable)
  • Certificate of Free Sale
  • ISO certification or other quality management documentation

4. Submit the Application

• The application is submitted to BPOM (Badan Pengawas Obat dan Makanan), the regulatory body in Indonesia responsible for medical device registration.
• BPOM will evaluate the device’s risk profile and determine whether additional information or inspections are required.

5. Evaluation by BPOM

• BPOM will review the application dossier to assess the safety, efficacy, and quality of the medical device.
• For Class 3 devices, BPOM may request additional clinical or performance data to evaluate risk and benefit.
• BPOM may also conduct inspections or request product samples for testing.

6. Issuance of Registration Certificate

• Upon successful evaluation, BPOM will issue the registration certificate (also known as the "Pendaftaran Alat Kesehatan" certificate) for the Class 3 medical device, allowing it to be marketed in Indonesia.

7. Post-Market Surveillance and Compliance

• After registration, manufacturers must comply with local regulations for post-market surveillance, including adverse event reporting, device recalls, and periodic updates to product information.
• Regular inspections by BPOM may also occur to ensure ongoing compliance with regulatory standards.

Timeline and Costs

• The process can take several months, depending on the complexity of the device and the completeness of the submission.
• Costs will vary based on the type of device and the complexity of the registration process. You may need to factor in registration fees, testing fees, and costs for local representation.

By following these steps and ensuring that your device complies with local regulations, you can successfully register a Class 3 medical device with the Indonesian MOH.

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