To apply for Class I medical device registration with the Indonesia Ministry of Health (MOH) through the BPOM (National Agency of Drug and Food Control), certain conditions must be met. These conditions ensure that the device complies with Indonesian regulations and is deemed safe and effective for use in the country. Below are the main conditions that must be met for Class I medical device registration in Indonesia.

Conditions for Applying for Class I Medical Device Registration in Indonesia

1. Classification of the Device

• The device must be correctly classified as a Class I medical device under the Indonesian medical device classification system.
• Class I devices are generally considered low-risk and include products such as non-invasive devices (e.g., bandages, gloves, thermometers, etc.).
• The classification of the device must meet the criteria set by BPOM based on its intended use, risk profile, and contact with the body (e.g., non-invasive, low-risk).

Note: Misclassification of a device as Class I when it should be Class II or III may lead to delays or reclassification to a higher-risk category, which requires a more complex and longer registration process.

2. Appointment of a Local Authorized Representative (AR)

• If the device is manufactured outside of Indonesia, the local authorized representative (AR) must be an Indonesian company registered with BPOM.
• The AR will be responsible for managing the entire registration process, ensuring that all required documents are submitted, and maintaining communication with BPOM.
• The AR must be authorized to submit applications and support post-market surveillance once the device is on the market.

3. Compliance with Indonesian Regulatory Standards

• The device must meet Indonesian regulatory standards for medical devices, which include safety, performance, and quality standards. This includes ensuring that the device:
  • Does not pose any significant risk to the user.
  • Complies with labeling, packaging, and documentation requirements.
  • Meets any specific national safety standards (e.g., electrical safety for electronic devices, biocompatibility for body-contacting devices).

4. Proof of Product Safety and Quality

• The manufacturer must provide evidence that the device has been tested and proven to meet international safety and quality standards. This typically includes:
  • A Good Manufacturing Practice (GMP) certificate or ISO 13485 certification (or equivalent) to demonstrate that the device is manufactured following internationally recognized quality standards.
  • If applicable, test reports (e.g., electrical safety, biocompatibility, sterility) to show the device’s compliance with relevant international standards.

Note: For Class I devices, the requirements are generally less stringent compared to higher-risk devices, but the device must still meet basic safety and performance standards.

5. Labeling Compliance

• The device’s labeling and packaging must meet the Indonesian regulatory requirements. Key points for labeling include:
  • Labels must be in Bahasa Indonesia (the official language of Indonesia).
  • Labels must include important information such as the device’s intended use, manufacturer’s name and contact information, instructions for use, warnings, and precautions.
  • Packaging must also comply with Indonesian standards, particularly in relation to the device’s safety and handling.

The AR should ensure that the translated labels and instructions meet the required format and content.

6. Certificate of Free Sale (CFS)

• A Certificate of Free Sale (CFS) is required to demonstrate that the device is legally sold in the country of origin or other countries.
  • The CFS must be issued by the regulatory authority in the manufacturer’s home country (e.g., FDA for the U.S., CE mark for the EU, or other recognized authorities).
  • The CFS must state that the device is legally sold in the market, and it must include the device’s name, description, and regulatory approval status.

Note: If the device is not sold in the country of origin but is approved in another market, evidence of approval in that market (e.g., CE certification, FDA clearance) can also be used.

7. No Clinical Trial Required for Class I Devices

• Class I devices generally do not require clinical trials to be conducted in Indonesia. This makes the registration process faster compared to higher-risk devices (e.g., Class II and III), which may require clinical data.
• However, for Class I devices that are innovative or involve new technologies, safety and performance test data may still be required to demonstrate the device’s safety and efficacy.

8. Importer or Distributor License (for Imported Devices)

• If the device is to be imported into Indonesia, the importer or distributor must hold a valid import license and be registered with BPOM.
• The importer must comply with Indonesian importation regulations for medical devices and ensure that all products sold in Indonesia are registered with BPOM.

Note: If you are manufacturing the device locally in Indonesia, the importer license is not required, but other local regulations may still apply.

9. Compliance with Post-Market Surveillance

• After registration, post-market surveillance is required to ensure that the device continues to meet safety and performance standards once it is in the market.
• The AR is responsible for reporting any adverse events, quality issues, or product recalls to BPOM.
• The AR must also ensure that the product is regularly inspected, and any necessary updates to the registration are communicated to BPOM.

10. Online Registration via BPOM’s e-RD System

• All applications must be submitted through BPOM’s e-RD system. The local authorized representative is required to create an account and submit the registration application online.
• The e-RD system is the official electronic platform for medical device registration in Indonesia, where the AR will upload the required documentation and track the status of the registration.

Summary of Conditions

To apply for Class I medical device registration with BPOM, the following conditions must be met:

1. Correct Classification: Ensure the device is classified as Class I.
2. Local Authorized Representative (AR): Appoint an AR in Indonesia to handle the application process.
3. Regulatory Compliance: Ensure the device meets Indonesian safety, performance, and quality standards.
4. Evidence of Safety and Quality: Provide GMP or ISO certification, and if applicable, safety and performance test reports.
5. Labeling Compliance: Ensure the device’s labeling and packaging comply with Indonesian requirements, with labels in Bahasa Indonesia.
6. Certificate of Free Sale (CFS): Provide a CFS from the country of origin or another market.
7. No Clinical Trial Needed: Clinical trials are not required for Class I devices, but test data may be necessary.
8. Importer License: If importing the device, the distributor or importer must have a valid BPOM import license.
9. Post-Market Surveillance: Adhere to post-market surveillance and reporting requirements.

Next Steps:

• Appoint a local authorized representative in Indonesia.
• Prepare all required documentation and ensure compliance with BPOM regulations.
• Submit the registration application via BPOM’s e-RD system.

If you need further clarification or assistance with any specific aspect of the process, feel free to ask!