In line with the objective to assist the healthcare professionals in the industry towards compliance with the Medical Device Act (Act 737), the Medical Device Authority (MDA) has issued a guidance document on June 2020.
The document lists the requirements on complaint handling for all medical devices applicable to exporters dealing with medical devices.
A system is put in place to handle complaints from patients, home users, healthcare practitioners, maintenance providers, or the general public. The user of any medical device can submit a complaint using a standard form to the establishments.
The document also discloses the procedure of receiving and recording complaints. The complaint should also be assessed to determine if it is a reportable event. All complaints received shall be recorded and tracked. The complaint is assessed based on the nature of the complaint and deemed as a reportable event.
Further, the Authorised Representative (AR) or manufacturer submits the complaint to the Authority within the specified time. These problems can be reported by submitting a Mandatory Problem Reporting Form and Investigation Form to the Authority.
The root cause of the incident is investigated upon the reporting and a field corrective action is conducted to avoid future recurrence of events.
The investigation will be assessed by the Authority to ascertain if it is satisfactory and they shall determine if the matter can be closed.
The implementation of the Corrective and Preventive Action (CAPA) is based on the root cause of the complaint.
The annexure of the guidance document contains the process flow for handling medical device complaints and the medical device complaint form.
Kindly refer to the link for the two guidance documents:-