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Field Safety Corrective Actions (FSCA) & Recalls

A Field Safety Corrective Action (FSCA) is any action taken by a manufacturer to reduce the risk of death or serious deterioration in health associated with a medical device already placed on the market. An FSCA is communicated to users through a Field Safety Notice (FSN).

When is an FSCA required?​

An FSCA is required when a post-market safety investigation reveals that a device on the market presents an unacceptable risk, such as:

  • A design defect that could cause harm
  • A manufacturing non-conformance affecting specific lots/batches
  • Incorrect or inadequate labelling that could lead to misuse
  • A previously unknown interaction or contraindication that poses safety risk

An FSCA may involve:

  • Device recall β€” removing devices from the market and/or the field
  • Device correction β€” modification, adjustment, relabelling, or software update of devices in the field
  • User advice β€” advising users of risks and precautions without physical action on the device

Notifying DAV​

The Authorised Representative must notify DAV before or simultaneously with initiating an FSCA (except where immediate action is required for patient safety, in which case notification must be made as soon as possible).

FSCA notification to DAV includes:

  • Device identification (name, model, registration/declaration number, affected batch/lot numbers)
  • Description of the problem and associated risk
  • Scope of the FSCA β€” number of devices affected, distribution countries
  • Description of the action being taken
  • Draft or final Field Safety Notice (FSN)
  • Timeline for completing the FSCA

Submissions are made through the DMEC portal.

Notifying provincial health departments​

In addition to DAV, the Authorised Representative or local distributor must coordinate notification with the relevant provincial health departments (Sở Y tế) in provinces where affected devices are distributed. Provincial health departments are the primary link to healthcare facilities receiving the FSN.

The Field Safety Notice (FSN)​

The FSN is the communication sent to users (healthcare facilities, patients where applicable) explaining the problem and what action they should take. An FSN must:

  • Clearly identify the affected device(s) β€” name, model, serial/lot numbers
  • Describe the identified problem and risk in plain language
  • State clearly what action the user should take (cease use, return device, apply a software update, etc.)
  • Provide contact information for the Authorised Representative or distributor
  • Be in Vietnamese (or accompanied by a Vietnamese translation)

FSCA completion reporting​

Upon completion of the FSCA, the Authorised Representative must submit a completion report to DAV through DMEC, confirming:

  • Total number of devices recovered/corrected
  • Outcome of the FSCA
  • Any residual risk assessment

DAV-initiated recalls​

DAV has authority to issue a mandatory recall or market suspension order for a medical device that poses an unacceptable risk to public health, even if the manufacturer has not initiated a voluntary FSCA.

Do not delay FSCA notification

Delayed notification of an FSCA to DAV is an offence under Decree 98/2021 and can significantly increase regulatory and legal exposure. When in doubt, notify early and update DAV as the situation develops.