Post Market Surveillance is mandatory for medical device manufacturers selling medical devices in Indonesia. Adverse Events (AEs), distribution records and other required communication with the Ministry of Health (MoH) is facilitated through the online E-Report and E-Watch Systems.
The MoH has harmonized their expectations with the ASEAN guidelines on Post Market Vigilance (Annex 5 of the AMDD).
Importation and/or Distribution Records (Submitted through E-Report System)
Traceability is not only a requirement of an effective quality system but also the requirement of regulatory bodies around the world. Keeping proper and appropriate importation and/or distribution records is an important component of ensuring traceability of medical devices in the market.
Complaint records (Submitted through E-Watch System)
An effective complaint handling system is an important part of any quality system. Any complaint received on a medical device should be evaluated and if necessary, thoroughly investigated and analyzed, and corrective actions should be taken. The results of the evaluation should lead to a conclusion regarding whether the complaint was valid, the causes of the complaint, and what actions were necessary to prevent further occurrences.
Dealers of medical devices in the Member State shall be required to:
maintain records of complaint reports and of actions taken in response to these reports, and produce such records for inspection by the Regulatory Authority in that Member State as and when requested; and establish and implement documented procedures to conduct effective and timely investigations of reported problems.
Adverse events (Submitted through E-Watch System)
A number of post-marketing risk assessment measures to ensure the continued safe use of medical devices may be undertaken. These measures include reporting from healthcare professionals, mandatory reporting from medical device dealers, and exchange of regulatory information with other medical device regulatory agencies. The mandatory reporting of AEs by medical device dealers is an important part of the post-market surveillance system. The objective of AE reporting and subsequent evaluations is to improve protection of the health and safety of patients, users and others by disseminating information that may reduce the likelihood of, or prevent repetition of AEs, or alleviate consequences of such repetition.
Field Safety Corrective Action (FSCA) (Submitted through E-Watch System)
A FSCA is required when it becomes necessary for the product owner of the medical device to take action (including recall of the medical device) to eliminate, or reduce the risk of, the hazards identified. A FSCA may still be necessary even when the medical device is no longer on the market or has been withdrawn but could still possibly be in use (e.g. implants). A FSCA only applies to a medical device that has already been distributed by the product owner. It does not arise when a product owner is exchanging or upgrading medical devices in the absence of a safety risk or when removals from the market are for purely commercial reasons. The product owner, physical manufacturer, authorized representative(s), importer and/or authorized distributor(s) in the Member State shall be responsible for performing and completing the FSCA in that Member State.
Excerpt from Annex 5 of the AMDD
Reporting Adverse Events Timeline
All AEs should be reported immediately and
Not later than 48 hours for events that represent a serious threat to public health,
Not later than 10 days for events that led to death or serious deterioration in state of health,
Not later than 30 days for events where a recurrence of which might lead to death or serious deterioration in state of health.
Contact Asia Actual with questions regarding Indonesia Post Market Surveillance. Our local, bi-lingual regulatory experts are well positioned to assist.