To register for Class II medical device approval with the Indonesian Ministry of Health (MOH), through the National Agency of Drug and Food Control (BPOM), follow these structured steps:

1. Verify Device Classification

• Confirm Device Class: Ensure that your device is correctly classified as a Class II medical device. Class II devices generally present moderate risks and may require additional documentation, such as clinical evaluations or performance testing.
• Determine Requirements: Based on the device’s classification, confirm the specific regulatory requirements with BPOM. Class II devices usually require submission of clinical evaluation reports, product testing results, and risk management documentation.

2. Appoint an Authorized Representative (if applicable)

• If you are a foreign manufacturer, you must appoint a local authorized representative in Indonesia. This representative will handle the submission and regulatory communication with BPOM on your behalf.
• The authorized representative must be a legally registered entity in Indonesia and have knowledge of BPOM regulations.

3. Prepare Required Documents

BPOM requires various documents for the registration of Class II medical devices. Here are the essential documents you will need to prepare:

1. Application Form: Complete the online registration form available on the BPOM e-registration system.
2. Certificate of Free Sale (CFS): A document issued by the country of origin certifying that the device is legally sold and meets the regulatory standards in its home country.
3. Product Information: Detailed technical information about the device, including product specifications, intended use, design, and performance characteristics.
4. ISO Certifications: Include ISO 13485 certification (Quality Management System for medical devices) and ISO 14971 (Risk Management).
5. Clinical Evaluation Reports: Provide evidence that the device has been evaluated for clinical safety and efficacy (if applicable).
6. Risk Management Documentation: A risk analysis based on ISO 14971 to demonstrate how the risks associated with the device are managed.
7. Good Manufacturing Practice (GMP) Certificate: Proof that the manufacturing facility complies with Good Manufacturing Practices (GMP). If you are a foreign manufacturer, you may need to provide a GMP certificate from your home country.
8. Post-Market Surveillance Plan: A document outlining how you will monitor the device's safety and performance in the market.
9. Labeling and Instructions for Use (IFU): Product labels and instructions for use must be in Bahasa Indonesia and meet regulatory standards.
10. Declaration of Conformity: A statement from the manufacturer declaring that the device complies with applicable regulatory requirements.

4. Submit the Application to BPOM

• Create an Account on BPOM’s Portal: To submit your application, create an account on BPOM’s e-licensing portal.
• Complete the Application: Fill out the required forms and upload all necessary documents.
• Payment of Fees: Pay the registration fee. The fee may vary depending on the type of device.
• Submit the Application: Submit the application for BPOM’s review. You will receive a tracking number to monitor the progress of your submission.

5. BPOM’s Review Process

BPOM will evaluate the documentation and the device’s compliance with Indonesian regulations:

1. Initial Review: BPOM checks the completeness of the submitted documents.
2. Technical Evaluation: BPOM evaluates the device’s safety, efficacy, clinical data, and risk management plans.
3. Good Manufacturing Practice (GMP) Compliance: If the manufacturer is foreign, BPOM may require evidence of GMP compliance or an inspection of the manufacturing facility.
4. Request for Additional Information: BPOM may request additional information or clarification if needed. Timely responses are important to avoid delays.

6. BPOM Inspection (if applicable)

If the device is manufactured outside Indonesia, BPOM may conduct an inspection of the manufacturing facility to ensure compliance with GMP and other local standards.

• Inspection Procedure: BPOM may visit the facility or require a GMP certificate from the manufacturer’s home country or certification authority.

• Foreign Manufacturing Facility: In some cases, if BPOM requires an inspection and cannot visit the site, they may rely on certifications from competent authorities in the manufacturing country.

7. Approval and Issuance of Registration Certificate

Once BPOM is satisfied with the documentation and evaluations, they will approve the registration. The outcome will be:

• Registration Certificate: BPOM will issue an official registration certificate, which will be valid for 5 years.
• Market Access: Upon receiving the registration certificate, your device is authorized for sale in Indonesia.

8. Post-Market Surveillance

After the registration is approved and the product is marketed, there are ongoing requirements for post-market surveillance:

• Adverse Event Reporting: Report any adverse events or product-related issues to BPOM.
• Market Monitoring: You must monitor the device’s safety and efficacy, and maintain a post-market surveillance system.

9. Renewal of Registration

The registration certificate is valid for 5 years. To ensure continuous market access, you must apply for renewal before the certificate expires. Start the renewal process at least 6 months before the expiration date to avoid any gaps in market availability.

Summary of Steps to Register Class II Medical Device with BPOM:

1. Verify Device Classification: Confirm that your device is a Class II medical device.
2. Appoint an Authorized Representative: If you are a foreign manufacturer, appoint a local representative in Indonesia.
3. Prepare Documentation: Gather all necessary documents (application form, CFS, ISO certificates, labeling, risk management, GMP, etc.).
4. Submit Application: Complete and submit the registration application through BPOM’s online portal.
5. BPOM Review: BPOM evaluates the application, including technical and safety assessments.
6. Inspection (if applicable): If required, BPOM conducts an inspection of the manufacturing facility.
7. Approval: BPOM approves the device and issues a registration certificate valid for 5 years.
8. Post-Market Surveillance: Monitor device safety and performance post-market and report any issues.
9. Renewal: Apply for registration renewal 6 months before the expiration date.

By following these steps and ensuring compliance with BPOM’s requirements, you can successfully register a Class II medical device in Indonesia.

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