Post Market Surveillance of Medical Devices in Indonesia
Post market surveillance of medical devices in Indonesia is under the control of the Surveillance Directorate of Medical Device and Household Health Supplies (PKRT) in the Ministry of Health (MoH). Manufacturers and their local authorized representative or importer are required to implement post market surveillance (PMS) in accordance with the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. However, each ASEAN member state is free in implementing the PMS requirements and each country has its own specificities, please read on to understand how post market surveillance is implemented in Indonesia.
What are the medical device PMS requirements in Indonesia?
There are four pillars to the post market surveillance system in Indonesia through which medical devices are proactively monitored and sampled by government civil police investigators who work together with hospitals and healthcare facilities, the police, customs and province health officers. These are:
- Medical device sampling and testing – periodically samples of medical devices are selected for laboratory testing to ensure compliance; any resulting corrective or preventive actions are informed to the manufacturer and importer
- Quality Management System (QMS) auditing – periodically the MoH will audit production and distribution facilities’ compliance to the Quality Management System
- Adverse event report auditing – mandatory obligation for distributors via the E-Watch system
- Advertising and labelling monitoring – the MoH supervises medical device advertising with related stakeholders and issues public warnings if necessary.
Manufacturers and importers are required to report the following through the Medical Device E-Watch system (see below):
- Unexpected Events (UE), referred to as Adverse Events (AE) in the AMDD
- Field Safety Corrective Actions (FSCA)
Importers and distributors are required to submit distribution records through the Medical Device E-Report system (see below) to ensure full traceability of the whereabouts of a medical device in case of recall.
Indonesia’s Medical Device E-Watch System
This is a national surveillance, early detection, and alert system for medical devices. Easily accessed by the public, it contains information on medical devices that may cause/have caused harm to patients, healthcare professionals or anyone affected by the medical device.
Users of a medical device, whether a patient or healthcare professional, may submit complaints and Unexpected Events via the E-Watch system.
The E-Watch system is also used manufacturers and distributors for mandatory reporting of Unexpected Events (KTD = Kejadian Tidak Diharapkan) and Field Safety Corrective Action (FSCA).
Unexpected Event Reporting
The criteria for reporting Unexpected Events to the Ministry of Health is as follows:
- An event has occurred in relation to the use of a medical device
- It has caused serious deterioration/serious injury to the user or others
- It has caused the death of a patient, user, or other person
- It has caused a serious threat to public health with mass impact
- An event could result in the death or serious injury to the user or others if repeated.
What are the timelines for Unexpected Event reporting?
| Adverse events | Report within |
|---|---|
| Serious threat to public health | 48 hours |
| Death | 10 days |
| Serious deterioration in state of health | 10 days |
| Possible death or serious injury if the adverse event were to recur | 30 days |
FSCA reporting
Field Safety Correction Action (FSCA) is one aspect in the Good Distribution Medical Device Directive (GDPMD) that must be met by distributors:
a.
Distributors must have standard operating procedures for FSCAs.
b.
Distributors shall assign responsibility for planning, implementing, and reporting corrective actions.
c.
Distributors shall establish product recall procedures after coordinating with producers. If or when a decision is made to withdraw the product, a recall notification must be made.
d.
Distributors must report their planned corrective action activities to the competent authority
e.
Distributors must inform corrective actions to consumers who have received the product, according to the level of importance of the FSCA
f.
Records of repair activities must be maintained.
Adequate corrective actions with respect to the safety and functional aspects of the product shall be determined as soon as possible and implemented in order to eliminate the acute hazard. Necessary action shall be carried out based on the guidelines from the Principal/Manufacturer.
Indonesia’s Medical Device E-Report System
This Medical Device & PKRT E-Report system was built to facilitate reporting on the production and distribution of medical devices and household health supplies (PKRT) by manufacturers, distributors and importers.
The system lists those products in circulation in Indonesia as well those that are exported and facilitates the traceability of medical devices lists complaints about medical devices and household health supplies. It is the appointed distributor’s responsibility to submit information to the E-report system.
How Andaman Medical can help you with post market surveillance in Indonesia
With 6 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including adverse event and FSCA mandatory reporting. Our local, in-house staff liaise with the Ministry of Health to help you maintain compliance once your medical device is placed on the market. Our services include:
- support for your mandatory reporting of Unexpected Events and Field Safety Corrective Actions
- evaluate your PMS data to ensure that existing processes and outputs are fully compliant
- monitor and report on any regulatory changes to ensure ongoing compliance