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Field Safety Corrective Actions (FSCA)

What Is an FSCA?​

A Field Safety Corrective Action (FSCA) is any action taken by a manufacturer to reduce a risk of death or serious injury associated with the use of a medical device that is already on the market. FSCAs include:

  • Device recalls (return of product to the manufacturer)
  • Device modifications or retrofits
  • Device exchanges (replacement of a device)
  • Device destructions
  • Advice to modify use, including retraining of users
  • Field safety notices (safety alerts to users without physical retrieval)

Triggering an FSCA in Indonesia​

An FSCA in Indonesia is triggered when:

  • The manufacturer initiates a global or regional FSCA that covers products on the Indonesian market
  • Kemenkes directs a recall or corrective action following market surveillance findings or adverse event investigation
  • A serious safety signal emerges from the Indonesian post-market surveillance programme

Notification to Kemenkes​

When an FSCA is initiated (whether manufacturer-led or regulator-directed):

  1. Prompt notification to Kemenkes via the Regalkes portal (and direct contact with the Directorate of Medical Devices if the FSCA is serious)
  2. Bahasa Indonesia FSCA communication — all field safety notices, recall letters, and user communications for the Indonesian market must be in Bahasa Indonesia (and may be bilingual)
  3. Distribution list — the LAR must provide Kemenkes with a list of all affected customers (hospitals, clinics, distributors) who received affected product
  4. Progress reports — Kemenkes may request regular FSCA progress reports

Traceability Requirements​

Effective FSCAs depend on traceability. For Class C and D devices, Kemenkes expects that the LAR can:

  • Identify all customers who received affected lot numbers
  • Contact all affected customers promptly
  • Confirm retrieval of returned product
  • Maintain records for a defined retention period post-FSCA

Establish traceability systems at the LAR level as part of the CDAKB quality system — before an FSCA is needed.

Recall Levels and Consequences​

Kemenkes sanctions can mandate a Level 3 recall:

  • NIE revocation
  • Mandatory recall of all product in the Indonesian market
  • The NIE holder bears the full cost of the recall operation

A manufacturer-initiated voluntary recall, executed promptly and transparently, is always treated more favourably than a Kemenkes-directed recall.