Mandatory Post-Market Surveillance (PMS) for Medical Devices in Indonesia

Mandatory Post-Market Surveillance (PMS) for Medical Devices in Indonesia

Post-Market Surveillance (PMS) is a mandatory and critical component of medical device compliance for all manufacturers selling in Indonesia. The Indonesian Ministry of Health (MoH) has harmonized its PMS expectations with the ASEAN guidelines on Post Market Vigilance (Annex 5 of the AMDD), focusing on traceability, complaint handling, and adverse event reporting.

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Reporting Systems and Compliance Responsibility

All communication and reporting related to PMS are centralized through two online platforms managed by the MoH:

• E-Report System: Used for submitting records of importation and distribution. Maintaining accurate records is essential for the traceability of medical devices within the Indonesian market.
• E-Watch System: Used for mandatory reporting of Adverse Events (AEs), complaint records, and Field Safety Corrective Actions (FSCA).

The local medical device dealer (importer/distributor/License Holder) is legally responsible for maintaining complaint records, establishing investigation procedures, and mandatory reporting to the MoH.

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Adverse Event (AE) Reporting Timelines

The timely reporting of Adverse Events is paramount. The required reporting timeline to the MoH depends on the severity of the event:

Event Severity	Reporting Timeline
Serious Threat to Public Health	Not later than 48 hours
Led to Death or Serious Deterioration in Health	Not later than 10 days
Recurrence Might Lead to Death or Serious Deterioration	Not later than 30 days

The objective of AE reporting is to improve public health and safety by disseminating information that can prevent the recurrence of safety issues.

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Field Safety Corrective Action (FSCA)

An FSCA is required when the product owner must take action (including product recall) to eliminate or reduce the risk associated with identified hazards.

• Scope: An FSCA applies to any medical device that has already been distributed, even if it has been withdrawn from the market but could still be in use (e.g., implants).
• Responsibility: The product owner, physical manufacturer, authorized representative(s), importer, and/or authorized distributor(s) in Indonesia are collectively responsible for performing and completing the FSCA within the country. FSCA does not apply to purely commercial actions like product upgrades without a safety risk.