To apply for Class C medical device registration in Indonesia, you will need to follow a structured process via the National Agency of Drug and Food Control (BPOM), which operates under the Ministry of Health (MOH). The registration process is done through BPOM's e-Registration System.

Here’s a step-by-step guide on how to apply and where to apply for the registration:

Where to Apply:

1. BPOM's e-Registration System:

   • The e-Registration System is an online portal provided by BPOM for the registration of medical devices in Indonesia.
   • All submissions for Class C medical device registration must be made through this online system. BPOM does not accept physical submissions.

2. BPOM Website:

   • You can access the e-Registration system through the official BPOM website:
     • BPOM Official Website: https://www.pom.go.id/

3. Local Authorized Representative (AR):

   • Foreign manufacturers are required to appoint a local Authorized Representative (AR) in Indonesia to handle the registration process. The AR will submit the application and handle all communications with BPOM on your behalf.

4. BPOM's Regional Offices:

   • For local manufacturers or if additional support is needed, BPOM has regional offices where you can seek assistance, but the main registration process is done online.

Steps for Class C Medical Device Registration in Indonesia:

Step 1: Appoint an Authorized Representative (AR) (for foreign manufacturers)

• Foreign manufacturers must appoint a local AR in Indonesia. The AR is responsible for submitting the application on your behalf and ensuring that all regulatory requirements are met.
• The AR must be a legally registered entity in Indonesia and knowledgeable about medical device registration processes.

Step 2: Prepare Required Documentation

• Prepare all necessary documents for the registration, including:
  1. Product Technical File (device description, classification, intended use, etc.).
  2. Clinical Evaluation Report (clinical data supporting safety and efficacy).
  3. Risk Management File (risk assessment and mitigation strategies).
  4. Labeling and Instructions for Use (IFU) in Bahasa Indonesia.
  5. Certificate of Free Sale (CFS) from the country of origin.
  6. Manufacturing License and GMP Certificate.
  7. Biocompatibility Test Results (if applicable).
  8. Performance Test Data (if applicable).
  9. Regulatory Certifications (if the device has been approved elsewhere, such as FDA or CE mark).
• All documents must be translated into Bahasa Indonesia (except for documents already in English or other recognized languages).

Step 3: Register on BPOM's e-Registration Portal

• The Authorized Representative (AR) must create an account on BPOM's e-Registration system.
• Submit the application by filling out the online forms and uploading all required documents. The documents should be in PDF format and organized according to BPOM's specifications.

How to Register:

• Visit the BPOM website and go to the e-Registration portal.
• Create an account or log in if you already have one.
• Complete the online application form with the relevant information about the medical device.
• Upload the required documents as specified by BPOM.
• Ensure that all fields are completed accurately to avoid delays.

Step 4: Pay the Registration Fee

• BPOM charges a registration fee for the submission of medical device applications.
• The fees vary depending on the device classification and the complexity of the application.
• The payment is typically made through the e-Registration system, and a receipt of payment will be generated.

Step 5: BPOM Review and Evaluation

• BPOM will review the application and the submitted documents. During this review, they may:
  • Request additional information or clarification.
  • Conduct tests or inspections (especially for high-risk devices).
  • Evaluate compliance with local regulatory requirements.
• For Class C devices, BPOM's review process may be more detailed and may take longer due to the higher risk associated with these devices.

Step 6: BPOM Inspection or Testing (if required)

• BPOM may require additional testing or an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).
• If testing or inspections are requested, ensure that you comply promptly to avoid delays.

Step 7: Receive Marketing Authorization (NOM)

• Once BPOM has completed the review and is satisfied with the submission, they will issue a Marketing Authorization (NOM - Nomor Registrasi Obat dan Makanan).
• The NOM allows you to legally sell and distribute the medical device in Indonesia.
• The Marketing Authorization is typically valid for 5 years, and you can renew it before expiration.

Step 8: Post-Market Surveillance

• After receiving the NOM, you are required to follow Indonesia’s post-market surveillance regulations.
• This includes reporting any adverse events, device recalls, or safety concerns to BPOM.
• BPOM may also conduct periodic audits or inspections to ensure ongoing compliance.

Summary of Steps to Apply:

1. Appoint a Local Authorized Representative (AR) (for foreign manufacturers).
2. Prepare all required documentation (technical file, clinical data, risk management, etc.).
3. Register on BPOM's e-Registration portal and submit the application online.
4. Pay the registration fee via the e-Registration system.
5. BPOM review and evaluation of the application.
6. Undergo additional testing or inspections (if required by BPOM).
7. Receive Marketing Authorization (NOM) from BPOM.
8. Comply with post-market surveillance requirements after approval.

Where to Apply

• BPOM Website and e-Registration System: The application is submitted online through BPOM's official website:
  • BPOM Official Website: https://www.pom.go.id/

By following these steps and working closely with a knowledgeable Authorized Representative (AR), you can successfully navigate the Class C medical device registration process in Indonesia. Let me know if you need more details on any specific part of the process!

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