Handling the Class II medical device registration with the Indonesian Ministry of Health (MOH) and BPOM (National Agency of Drug and Food Control) involves a series of steps, from preparing your documentation to maintaining compliance with Indonesian regulations after approval. Here’s a step-by-step guide to effectively navigate this process:

Step-by-Step Guide to Handling Class II Medical Device Registration

1. Determine the Classification and Appointment of Authorized Representative

• Device Classification: First, verify that your device is classified as Class II. Class II devices typically include those with moderate risk, such as diagnostic equipment, dental devices, or certain surgical instruments.
• Authorized Representative: If you are a foreign manufacturer, you need to appoint an authorized representative in Indonesia to handle the registration process and ensure compliance with Indonesian regulations. This representative must be registered with BPOM.

2. Prepare Necessary Documentation

The next step is to gather and prepare all required documentation to submit your registration application to BPOM. Missing or incomplete documents can delay the registration process.

Key Documents Needed for Class II Medical Device Registration

1. Application Form: Complete the BPOM medical device registration application form available online through BPOM’s e-registration platform.
2. Certificate of Free Sale (CFS): Obtain a CFS from the country of origin that confirms the device is legally sold there and complies with local regulations.
3. Product Specifications: Include a detailed description of the device, including its intended use, technical specifications, and performance characteristics.
4. ISO Certifications: Submit ISO 13485 (for quality management systems) and other relevant certificates (e.g., ISO 14971 for risk management).
5. Clinical Evaluation Report (if applicable): Depending on the device, BPOM may request a clinical evaluation report or clinical data to support its safety and efficacy.
6. Labeling and Instructions for Use (IFU): Ensure that the labeling is compliant with Indonesian regulations, and that the IFU is provided in Bahasa Indonesia.
7. GMP Certification: If applicable, submit proof of Good Manufacturing Practices (GMP) compliance for the manufacturing facility.
8. Declaration of Conformity: A statement confirming the device meets the applicable regulatory standards.

3. Submit the Registration Application

Once all the documents are prepared, you can submit your application through BPOM’s e-registration system (or e-licensing system, depending on the current setup).

Steps for Submission

1. Create an Account: Create an account in BPOM’s online platform if you do not already have one.
2. Complete the Online Application: Fill in the required fields and upload the necessary documents.
3. Pay Registration Fees: BPOM charges a registration fee for processing the application. This fee varies depending on the device and its classification.
4. Track Submission: After submission, you will receive a confirmation and can track the progress of your application via the BPOM portal.

4. BPOM’s Review and Evaluation

After submission, BPOM will start reviewing the documents. This involves checking the safety, efficacy, and regulatory compliance of the device. If everything is in order, BPOM will proceed to approve the registration.

Review Process Details

• Initial Document Review: BPOM will first check the completeness of your submission. If any documents are missing or unclear, you will be asked to provide additional information or corrections.
• Technical Evaluation: BPOM assesses the technical specifications, clinical data, risk management, and product safety to ensure compliance with international standards.
• GMP Inspection: If the manufacturing facility is outside of Indonesia, BPOM may require a GMP inspection or a GMP certificate from the manufacturer.
• Regulatory Assessment: BPOM evaluates whether the device meets the safety, efficacy, and performance requirements defined by Indonesian regulations.

5. Address BPOM’s Requests for Additional Information

During the review, BPOM may ask for clarifications or additional documentation. It’s crucial to respond promptly to avoid delays in the process. Ensure that all requests from BPOM are handled efficiently.

6. Final Approval and Issuance of Registration Certificate

If BPOM is satisfied with the application and documentation, they will issue the registration certificate, granting market access in Indonesia. This certificate will be valid for 5 years, after which renewal is required.

Issuance Details

• Once the device is approved, BPOM will issue a registration certificate for the device, which is required for distribution in Indonesia.
• BPOM will also list the product in their database, allowing importers and distributors to sell the device in the market.

7. Post-Approval and Post-Market Surveillance

After receiving the registration certificate, you must comply with post-market requirements, such as monitoring the device’s performance in the market and reporting any adverse events or defects.

Post-Approval Requirements

1. Post-Market Surveillance: Implement a system for tracking device safety and performance in the market. BPOM may require periodic reports.
2. Adverse Event Reporting: Any adverse events (e.g., malfunctions or harm caused by the device) must be reported to BPOM promptly.
3. Renewal of Registration: Registration must be renewed every 5 years. Begin the renewal process at least 6 months before the expiration date.

8. Handling Device Modifications and Updates

If there are any changes to the device (e.g., updates to the design, labeling, or intended use), you must notify BPOM. Significant changes may require a new submission and approval process.

Tips for Effective Registration Management

1. Ensure Complete Documentation: Thoroughly check all documents before submission to avoid delays caused by incomplete or inaccurate information.
2. Maintain Communication with BPOM: Stay in regular contact with BPOM or your local representative to track the status of the application and address any queries quickly.
3. Monitor Post-Market Activities: Once your device is on the market, monitor its performance and ensure you comply with post-market surveillance requirements to maintain your registration.
4. Plan for Renewal: Don’t wait until the last minute to renew your registration. Submit your renewal application at least 6 months before expiration to ensure there’s enough time for review.

Summary of Steps for Handling Class II Medical Device Registration in Indonesia

1. Determine Classification & Appoint Authorized Representative: Confirm your device is Class II and appoint a local representative if necessary.
2. Prepare Documentation: Gather all required documents, including the application form, CFS, ISO certifications, product specifications, clinical data, and GMP certification.
3. Submit Application: Complete and submit the application through BPOM’s online portal and pay the registration fee.
4. BPOM Review and Evaluation: BPOM will review your documents, evaluate technical specifications, and may request additional information or conduct a GMP inspection.
5. Approval and Issuance: If everything is in order, BPOM will approve the registration and issue the registration certificate.
6. Post-Market Surveillance: After registration, continue monitoring the device’s performance and ensure compliance with post-market surveillance requirements.
7. Device Modifications: Notify BPOM if any modifications or updates are made to the device.

By following these steps, you can effectively handle the registration of a Class II medical device with the Indonesian MOH and BPOM. Let me know if you need more specific advice or help with any part of the process!

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