For Class A medical devices registered with Indonesia's Ministry of Health (MOH), annual reviews are not required. The registration process for Class A devices is relatively straightforward and involves a 5-year validity period for the Izin Edar (distribution license).

Key Points on the Review Process for Class A Medical Devices:

1. Initial Registration Validity: Once the device is registered and the Izin Edar is issued, it is typically valid for 5 years. There is no requirement for an annual review during this period.

2. Renewal Process: While there is no annual review, renewal of the Izin Edar is required after 5 years. To renew the registration, the manufacturer or local authorized representative must submit an updated application and relevant documents to BPOM or MOH before the license expires.

3. Post-Market Surveillance: Although no annual review is required, manufacturers and distributors must still comply with post-market surveillance obligations. This involves monitoring the device's safety, effectiveness, and any adverse events. Any significant changes or safety concerns must be reported to the authorities.

4. Updates on Documentation: If any major changes occur to the device (such as a modification in design, manufacturing process, or intended use), the manufacturer must update the MOH and potentially submit new documentation for review, even if these changes occur before the 5-year renewal period.

5. Inspections or Audits: Indonesia's regulatory authorities, such as BPOM or the Ministry of Health, may conduct inspections or audits to ensure ongoing compliance, but these are not routine annual reviews unless specific concerns arise.

Summary

• Annual reviews are not required for Class A medical devices in Indonesia.
• Renewal of registration is required every 5 years.
• Post-market surveillance and reporting of any safety issues are ongoing responsibilities.

This makes the process relatively less burdensome compared to higher-risk devices, where more frequent reviews and updates may be required.