Malaysia’s Medical Device Authority (MDA) has issued two new sets of guidelines establishing post-market reporting and corrective action requirements for devices sold in the country.

The new guidelines cover field safety and corrective action as well as complaint handling rules.

MDA field corrective action requirements

Malaysian regulators state that they consider medical device manufacturers ultimately responsible for determining whether field corrective actions are warranted, but do require manufacturers to perform risk assessments in compliance with the ISO 14971 risk management standard. Manufacturers or authorized representatives in Malaysia may initiate their own field corrective actions based on their own post-market surveillance data, or the MDA may advise that firms take such steps to safeguard public health following adverse events.

If a manufacturer or representative does opt to initiate a field corrective action, the firm must submit a field safety notification as well as a preliminary report to device users as well as to the MDA within 48 hours of beginning the action, according to the guidance. Then, firms will typically have 30 days to conduct their field corrective actions and then submit final reports to the MDA.

Sample forms for field safety notifications are included in the MDA guidance.

Complaint handling

The MDA guidance on complaint handling requires manufacturers or in-country representatives authorized to sell their devices in Malaysia to report all complaints related to death or serious injury from use of their devices to the Malaysian regulator. In addition, the guidance outlines record maintenance requirements pertaining to complaints.

Information covered by MDA complaint record maintenance rules includes device information; manufacturer and/or authorized representative, importer or distributor details; complaint description and history; and complaint reporter contact details. Firms must also keep records of all actions they undertake to address complaints involving their devices.

Firms are also required to establish written procedures for complaint handling that clearly identify key personnel who will manage any potential incidents, as well as explain appropriate record retention and maintenance associated with any complaints.