The procedure for Class I medical device registration with the Indonesia Ministry of Health (MOH) involves several steps to ensure compliance with Indonesian regulations. Here's a detailed breakdown of the steps:

Step-by-Step Procedures for Class I Medical Device Registration

1. Confirm Device Classification

• Classification Determination: Ensure your medical device qualifies as a Class I device, which is typically a low-risk device. Class I devices generally include non-invasive devices, such as thermometers, bandages, and gloves.
• Class I devices are exempt from clinical trials, but they must meet the regulatory standards for safety and performance.

2. Appoint a Local Authorized Representative (AR)

• If you are a foreign manufacturer, you must appoint a local authorized representative (AR) in Indonesia. This AR will handle the registration process with the Ministry of Health and communicate with the National Agency of Drug and Food Control (BPOM).
• The AR must be a licensed entity in Indonesia authorized to distribute medical devices.

3. Prepare Required Documents

You will need to prepare and submit several key documents. The documents required for Class I registration may include:

• Company Registration: Valid registration and documentation of the local representative or distributor.
• Manufacturer Information: Proof that the manufacturer complies with relevant international standards (e.g., ISO 13485, Good Manufacturing Practice (GMP)).
• Certificate of Free Sale (CFS): A document from the country of origin confirming the device is approved and freely marketed in that country.
• Product Description: A description of the device, its intended use, and technical specifications.
• Labeling: The product’s labeling must be translated into Bahasa Indonesia and meet local regulatory requirements.
• Test Reports/Technical Documentation: Any relevant safety or performance testing reports that demonstrate the device’s compliance with international standards (e.g., IEC, ISO).
• Packaging Information: Details on the packaging and any shipping requirements.

4. Submit the Application via the e-RD System

• The registration application for Class I devices is submitted electronically through the e-RD (electronic Registration) system.
• The local authorized representative will submit the application on behalf of the manufacturer via the BPOM e-RD system.
• The following steps are involved in submitting the application:
  1. Create an account: The AR must create an account on the e-RD system.
  2. Complete the registration form: The AR will complete the registration application, providing information about the device and uploading the necessary documents.
  3. Upload supporting documents: All required documentation must be submitted in digital format through the system.

5. BPOM Evaluation

• BPOM (Badan Pengawas Obat dan Makanan) will review the submitted documents. This includes an evaluation of:
  • Product compliance: Ensuring the device meets safety, performance, and labeling requirements.
  • Manufacturing compliance: Ensuring the manufacturer complies with international manufacturing standards.
• For Class I devices, BPOM typically reviews the submission more quickly than for higher-risk devices, as the risk to patient safety is lower.

6. Issuance of Registration Certificate

• After the application has been successfully evaluated, BPOM will issue a registration certificate for the medical device.
• The registration certificate is usually valid for 5 years, and the device can be marketed and distributed in Indonesia during this period.
• Once the certificate is issued, the device can be legally imported, marketed, and sold in Indonesia.

7. Post-Market Surveillance and Compliance

• Even after the device is registered, it must comply with post-market surveillance requirements, including reporting adverse events, complaints, and recalls if necessary.
• The local representative is responsible for ensuring that the device remains in compliance with any updated regulations during its time on the market.
• The registration must be renewed every 5 years.

Timeline and Costs

• Timeline: The registration process for Class I medical devices generally takes around 1-3 months, depending on the completeness of your application and the review time by BPOM.
• Costs: The registration fees are typically lower for Class I devices compared to higher-risk devices. The exact cost will depend on the specific device and administrative requirements.

Key Considerations

• Language Requirements: All documentation, including labels and instructions, must be provided in Bahasa Indonesia.
• Regulatory Changes: Be aware of any changes in Indonesian medical device regulations, as these may affect the registration process or requirements for your device.
• Authorized Representative: The local authorized representative must be proactive in managing the registration process and ensure compliance with local laws, as they will be the point of contact for any regulatory inquiries or audits.

Summary of Steps

1. Confirm device classification as Class I.
2. Appoint a local authorized representative (AR).
3. Prepare necessary documents, including CFS, product description, safety reports, labeling in Bahasa Indonesia, etc.
4. Submit application via e-RD system.
5. BPOM evaluation of submitted documents.
6. Receive registration certificate upon approval.
7. Compliance with post-market surveillance requirements and device renewal after 5 years.

By following these steps, you can successfully register your Class I medical device with the Indonesia Ministry of Health and legally distribute it in Indonesia.

Let me know if you'd like more information about any specific part of the process!

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