To apply for Class I medical device registration with the Indonesia Ministry of Health (MOH), the process is done through the e-RD (electronic Registration) system, which is managed by the Indonesian National Agency of Drug and Food Control (BPOM). The local authorized representative (AR) is required to handle the submission process, as foreign manufacturers cannot submit directly. Below is a detailed guide on how to apply for Class I medical device registration and where to submit the application.

Steps to Apply for Class I Medical Device Registration

1. Appoint a Local Authorized Representative (AR)

• As a foreign manufacturer, you must appoint a local authorized representative (AR) in Indonesia to handle the registration process.
• The AR is typically an Indonesian company registered with BPOM that has the legal authority to manage the registration process on behalf of the manufacturer.
• The AR is responsible for submitting all the required documents, ensuring the application complies with Indonesian regulations, and communicating with BPOM.

2. Prepare the Required Documents

Before submitting the application, the AR must gather and prepare the following documents, which are required for registration:

• Manufacturer Information: Business license, GMP or ISO certification.
• Device Information: Detailed device description, labeling (in Bahasa Indonesia), risk classification, and photos of the device.
• Certificate of Free Sale (CFS): A certificate from the country of origin showing the device is legally sold there.
• Safety and Performance Test Reports (if applicable): Any relevant safety and performance data or test results (e.g., biocompatibility, electrical safety).
• Packaging and Labeling Information: Product labeling, packaging details, and instructions for use in Bahasa Indonesia.

3. Register on the BPOM e-RD Portal

• The application must be submitted through the BPOM's e-RD system. The AR will need to create an account or log in to the e-RD system.

• The official e-RD portal can be accessed at:
  BPOM e-RD Portal

• The AR will fill out the online registration form, providing details about the manufacturer, device, and its classification, and uploading all required documents.

4. Submit the Application

• After completing the online registration form and uploading all required documents, the AR will submit the application electronically via the e-RD portal.
• Once submitted, the AR will receive a confirmation receipt for the application.

5. BPOM Evaluation and Approval

• BPOM will review the submitted application and documents to ensure compliance with Indonesian medical device regulations.
• Class I devices are generally low-risk and are subject to a relatively faster review process compared to higher-risk devices.
• If BPOM finds the submission complete and in compliance with regulations, they will approve the registration.

6. Receive the Registration Certificate

• Upon approval, BPOM will issue a registration certificate for the medical device. This certificate authorizes the device to be marketed and distributed in Indonesia.
• The registration certificate is typically valid for 5 years from the date of issuance. After 5 years, a renewal application is required.

7. Post-Market Surveillance

• After obtaining registration, the device must adhere to post-market surveillance requirements, including reporting any adverse events or quality issues.
• The local AR is responsible for ensuring compliance with post-market surveillance and ensuring the device remains in compliance with regulations during its time on the market.

Where to Apply

1. BPOM e-RD Portal:

• The application for Class I medical device registration is submitted through the BPOM's e-RD system. The e-RD system is the official electronic platform for all medical device registrations in Indonesia.
• The portal can be accessed by the local authorized representative at the following link:
  BPOM e-RD Portal

2. Authorized Representative (AR) Role:

• The local authorized representative (AR) is responsible for creating an account and submitting the registration through the e-RD portal. The AR ensures all documents are correctly uploaded and submitted on behalf of the foreign manufacturer.

3. BPOM Headquarters:

• In case of any queries or issues that arise during the registration process, the BPOM office in Jakarta or the nearest BPOM branch office can provide assistance, although the process is mainly managed online.

Summary of the Process

1. Appoint a local authorized representative (AR) in Indonesia.
2. Prepare required documents (manufacturer info, device info, CFS, labeling, test reports, etc.).
3. Register via the BPOM e-RD system.
4. Submit the application electronically.
5. BPOM will review and approve the application.
6. Receive the registration certificate and begin marketing the device.
7. Ensure compliance with post-market surveillance.