Field Corrective Action (FCA)
Field corrective action is also a post market requirements need to be followed by an establishment under Section 41 of Act 737. To ensure compliance with these requirements, the establishment has taken proactive steps to inform about the corrective actions made.
Manufacturers or their representatives may need to carry out corrective or preventive activities in relation to their medical devices. This corrective action can be initiated through the establishment post market information such as product complaints, incident reports and so on. These include the field corrective actions taken by the manufacturer to reduce the risk of harm to the patient, the operator or others and/or to reduce the re-occurrence of the incident.
Field corrective action means any action taken by the establishment to reduce the risk of incidents to enhance the safety and performance of a medical device. These may include:
- Return of the medical device to the manufacturer or its representative.
- Modification of the medical device.
- Exchange of medical devices.
- Destruction of medical devices.
- Specific advice by the manufacturer on the use of medical devices.
Safety Notice means any communication of information released by the establishment to users of the corrective action to be taken in the field.
To Notify FCA
Field corrective action may be requested by the Medical Device Authority for specific cases such as complaints and problem reports mandatory. Field safety notice should be presented to the user and the Medical Device Authority before/during corrective action is taken.
Template field safety notice form can be download here.
Template field corrective action form can be download here
Completed forms can be submitted to the Office of the Medical Device Authority at the address :
Level 6 , Prima 9 ,
Prima Avenue II , Persiaran APEC ,
email to Notice_FCA @ mda.gov.my