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. Below are the key processes involved in this registration procedure:

1. Classification Verification

• Confirm the Classification: Before starting the application process, ensure that your device is classified as Class II according to Indonesian regulations. Class II medical devices typically present moderate risks and may include devices like diagnostic equipment, dental instruments, or some surgical tools.
• Authorized Representative (if applicable): If you are a foreign manufacturer, you must appoint a local authorized representative in Indonesia to handle the registration process and regulatory compliance. This representative is responsible for liaising with BPOM on your behalf.

2. Documentation Preparation

Preparing the necessary documents is a crucial part of the process. Missing or incomplete documentation can delay registration.

Required Documents for Class II Medical Device Registration:

1. Application Form: Complete the BPOM medical device registration application form, which is available on the BPOM's e-registration portal.
2. Certificate of Free Sale (CFS): Obtain a CFS or a similar document from the country of origin that confirms the device is legally marketed there.
3. Product Information and Specifications: Provide detailed information about the device, including its technical specifications, intended use, and product labeling.
4. ISO Certifications: Submit copies of ISO 13485 (quality management) and, if applicable, ISO 14971 (risk management) certifications.
5. Clinical Evaluation Report (if applicable): Depending on the device, BPOM may require a clinical evaluation or clinical data to demonstrate its safety and efficacy.
6. Good Manufacturing Practice (GMP) Certificate: Submit evidence that the manufacturing facility adheres to GMP. If the facility is located outside Indonesia, BPOM may require an inspection or certification from the competent authority in the manufacturing country.
7. Post-Market Surveillance Plan: Provide a plan for tracking the device's performance after it is placed on the market, including how you will handle adverse event reporting.
8. Risk Management Documentation: Ensure you have submitted risk management documentation, in line with ISO 14971.
9. Labeling and Instructions for Use (IFU): Provide the product’s labeling and instructions for use (in Bahasa Indonesia).

3. Application Submission

Once all documents are ready, you need to submit the application to BPOM:

1. Create an Account: If you don’t already have an account, create one on BPOM’s e-licensing platform or e-registration system.
2. Complete the Application: Fill out the online application form, upload all the required documents, and submit them through the BPOM portal.
3. Pay Registration Fee: BPOM requires a registration fee, which can vary depending on the type of device. Ensure the payment is made as per BPOM’s instructions.
4. Submit and Track: After submission, you will receive a confirmation receipt and can track the status of your application through BPOM’s online portal.

4. BPOM's Initial Review

After submission, BPOM will conduct an initial review to check the completeness of the application.

• Document Evaluation: BPOM checks if all the required documents are present and compliant with local regulatory standards. This includes verifying the Certificate of Free Sale, product labeling, and ISO certifications.
• Outcome: If any documents are missing or there are issues with the application, BPOM will request corrections or additional information. If everything is in order, BPOM proceeds with the technical evaluation.

5. Technical and Safety Evaluation

In this phase, BPOM evaluates the technical aspects of the medical device, ensuring it complies with safety, efficacy, and regulatory standards.

• Technical Review: BPOM assesses the device's specifications, risk management, clinical data, and clinical evaluation reports (if applicable).
• Regulatory Compliance: The device must meet Indonesian National Standards (SNI) or equivalent international standards.
• Labeling Compliance: BPOM checks that the device’s labeling and instructions for use comply with Indonesian regulations and are provided in Bahasa Indonesia.

6. GMP Inspection (If Applicable)

• GMP Compliance: If the device is manufactured outside Indonesia, BPOM may request a GMP certificate from the manufacturing site, or they may require an inspection of the facility.
• Foreign Facility Inspections: If BPOM requires a site inspection, this can cause delays, as the process may involve coordination with regulatory authorities in the country of origin.

7. Review of Additional Information or Modifications (if required)

• If BPOM finds any issues with the application or the product, they may request additional information or modifications. This can include clarifications on risk management, product labeling, or clinical data.
• Responding quickly and thoroughly to these requests will help minimize delays.

8. Final Review and Approval

Once BPOM completes the evaluation and is satisfied with the documents, they will issue an approval for the device registration. If BPOM has no further concerns, the product is approved for sale in Indonesia.

• Registration Certificate: BPOM issues a registration certificate, which is required to legally market the device in Indonesia. This certificate is typically valid for 5 years.

9. Post-Market Surveillance and Ongoing Compliance

• Post-Market Surveillance (PMS): After the device is registered, the manufacturer or authorized representative must implement a post-market surveillance plan, monitoring the device’s safety and performance in the market.
• Adverse Event Reporting: Any adverse events or product failures must be reported to BPOM.
• Renewal: The registration certificate is valid for 5 years. You must submit a renewal application well before the certificate expires to avoid disruptions in your market access.

Additional Considerations

• Changes to Product: If there are any changes to the device (e.g., new features, intended use, or manufacturing process), these must be reported to BPOM. For significant changes, you may need to submit a new registration.
• Indonesian Language Requirement: All documents related to the device, including the labeling, instructions for use, and clinical data (if applicable), must be provided in Bahasa Indonesia.
• Communication with BPOM: Maintain regular communication with BPOM or your appointed local representative to track the status of your application and respond promptly to requests for additional information.

Timeline for Class II Medical Device Registration

• Preparation of Documents: Can take 2-4 weeks depending on the complexity of the device.
• Review Process: BPOM’s review typically takes 3 to 6 months, including document verification, technical evaluation, and inspections (if needed).
• Approval and Issuance: After successful review, BPOM issues the registration certificate, and the device can be marketed in Indonesia.

Summary of Key Steps in Class II Medical Device Registration in Indonesia:

1. Confirm Classification and Appoint Authorized Representative (if applicable).
2. Prepare Necessary Documents (application form, CFS, product specifications, ISO certifications, clinical data, etc.).
3. Submit Application via BPOM’s online portal.
4. BPOM’s Initial Review to check for completeness.
5. Technical and Safety Evaluation by BPOM.
6. GMP Inspection (if applicable, especially for foreign manufacturers).
7. Request for Additional Information (if necessary).
8. Final Review and Approval by BPOM, leading to issuance of the registration certificate.
9. Post-Market Surveillance and Adverse Event Reporting after registration.

By following this process and ensuring compliance with the documentation and regulatory requirements, you can successfully navigate the Class II medical device registration process with Indonesia MOH and BPOM. Let me know if you need further assistance!

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