The process for registering a Class A medical device with Indonesia’s Ministry of Health (MOH) typically takes 2 to 4 months. The duration may vary depending on the completeness and accuracy of the application, as well as the workload of the regulatory authorities. Class A devices are considered low-risk, so their review process is generally faster compared to higher-risk medical devices.

Stages of the Review Process for Class A Medical Device Registration with Indonesia MOH

1. Preparation of Application (1–2 Weeks)

• What Happens: The first stage involves preparing and compiling all the necessary documentation, including technical data, device descriptions, labels, and proof of compliance with applicable standards (e.g., ISO 13485, SNI).
• Documents Required:
  • Certificate of Free Sale (CFS).
  • Technical documentation (device description, intended use, specifications).
  • ISO 13485 certification (or equivalent).
  • Quality management system documentation.
  • Labeling and IFU in Bahasa Indonesia.
• Estimated Time: This stage generally takes 1–2 weeks depending on the readiness of the documents. If any documents need to be prepared or translated, this can extend the timeline.

2. Submission of Application (via e-Registration) (1–2 Weeks)

• What Happens: Once the documentation is ready, the local authorized representative (distributor) in Indonesia submits the application to the MOH or BPOM through the e-registration system. The application includes all the required technical documents, product description, and other supporting materials.

• Submission Platform: The registration is done electronically via the Indonesian regulatory system, which streamlines the process. The application is assessed by the authorities for completeness and compliance with Indonesian medical device regulations.

• Estimated Time: This stage can take 1–2 weeks, depending on how fast the authorized representative can submit the application and if there are any immediate clarifications or issues raised during submission.

3. Document Review by MOH/BPOM (4–6 Weeks)

• What Happens: After the application is submitted, the Indonesian Ministry of Health (MOH) or BPOM will review the documents to ensure that the medical device complies with all applicable regulations and standards. For Class A devices, this review is relatively straightforward, but still involves checking the technical documentation, quality management system, labeling, and any other safety information.
  • Technical Review: The authorities will evaluate whether the device meets Indonesian standards for safety, performance, and labeling requirements.
  • Risk Assessment: A risk assessment will be conducted, though this is generally simpler for Class A devices compared to higher-risk categories.
• Estimated Time: The document review typically takes 4–6 weeks, depending on the completeness of the application and the workload of the MOH. If any additional information is required or if there are discrepancies in the submitted documents, the process may take longer.

4. Issuance of Izin Edar (Distribution License) (1–2 Weeks)

• What Happens: Once the document review is completed and the authorities are satisfied with the application, the MOH will issue the Izin Edar (distribution license), which is required for marketing and distributing the device in Indonesia. The device will also receive a Certificate of Registration confirming its approval for sale in the country.
  • Approval Notification: Once approved, the local authorized representative will receive the official registration certificate, and the device can be legally distributed in Indonesia.
• Estimated Time: Issuance of the Izin Edar typically takes 1–2 weeks once the review process is completed and everything is in order.

Overall Timeline:

• Total Time for Registration: The entire registration process typically takes between 2 and 4 months, depending on the completeness of the submission and the time required for document review. This includes:
  • Preparation: 1–2 weeks.
  • Submission: 1–2 weeks.
  • Review: 4–6 weeks.
  • Issuance: 1–2 weeks.

Factors That Can Affect the Timeline:

1. Completeness of the Application: If the application is missing key information or documents, it can delay the review process. Make sure all required documents are included in the initial submission.
2. Regulatory Workload: During peak periods, such as when there is an influx of applications, processing times may be longer.
3. Clarifications and Additional Information: If the authorities request clarifications or additional information about the device, this can add time to the process.
4. Quality of Technical Documentation: The clearer and more detailed your technical documentation, the quicker the review process is likely to be.

Summary of the Review Process:

1. Preparation of documents (1–2 weeks).
2. Submission of application via e-Registration (1–2 weeks).
3. Document review by MOH/BPOM (4–6 weeks).
4. Issuance of Izin Edar (1–2 weeks).

In total, the entire registration process for a Class A medical device in Indonesia typically takes 2 to 4 months, assuming there are no major issues with the application.

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