MDA mandatory problem reporting (adverse event reporting).

Reporting deadlines under section 40 of Act 737.

Under MDA/GD/0014 the clock starts as soon as any person at the manufacturer or its authorised representative, including sales staff, becomes aware of the incident. The duty applies only to devices registered in Malaysia, and covers incidents inside and outside Malaysia. Not reporting is an offence under section 40(2): a fine of up to RM200,000, up to two years’ imprisonment, or both.

Who reports what

The manufacturer and AR must set up communication channels with everyone else in the supply chain so that reports, investigations and any field corrective action reach them. “Immediately” means without any delay that cannot be justified. A foreign manufacturer’s reports go through its Malaysian AR, which holds the registration.

Is it reportable? The three criteria

An incident is reportable when all three apply (MDA/GD/0014, section 3.2.1):

1. an incident has occurred;
2. the medical device is associated with the incident; and
3. it led to death, a serious deterioration in health, a serious threat to public health, or no harm but might lead to death or serious injury if it recurred.

A serious deterioration in health includes a life-threatening illness or injury, permanent impairment of a body function or permanent damage to a body structure, or a condition that needs medical or surgical intervention to prevent either. Near-misses count: harm may have been avoided only by luck or by staff stepping in. Where several devices and drugs are involved and the link is unclear, assume the device may have caused or contributed to the incident. In doubt, report.

• IVDs usually cause indirect harm: misdiagnosis, delayed diagnosis or treatment, inappropriate treatment, or transfusion of inappropriate materials, often from false results or inadequate calibration or quality control. These are reportable. See IVD registration.
• Use error is reportable when it caused death, a serious deterioration in health or a serious public health threat, when the manufacturer sees a significant change in its trend or pattern, or when it triggers a field corrective action. Other use errors are handled in the quality system, and a decision not to report must be justified and documented.
• Off-label use is not reported by the manufacturer.
• Trend reports are required when known, labelled side effects become more frequent or more severe in a way that could lead to death or serious deterioration in health.

When no report is needed

MDA/GD/0014 section 5 lists five conditions, each with MDA’s own examples:

Two further exclusions: incidents with devices under clinical investigation are outside the scope of MDA/GD/0014, and an overseas incident needs no Malaysian report if it was reported to that country’s regulator and a field corrective action was taken there and on all affected devices in Malaysia (regulation 5(7) of the 2019 Duties and Obligations Regulations).

What the report contains

Annex A of MDA/GD/0014 is the template for the online report; the layout can vary, but every field is mandatory. It asks for:

• where the incident happened (in Malaysia, with the type of facility, or which country);
• the device’s class, Malaysian registration number, name, brand and manufacturer, and whether it is available in Malaysia;
• affected batch, lot or serial numbers and expiry dates;
• the report category, the date of the incident and the date your establishment became aware of it;
• the incident type, a description, the operator, how the device was being used and where it is now;
• any immediate action taken, such as advice to stop use or quarantine;
• when the investigation report will follow: within 30 days, or a requested 90, 120 or 150 days.

The investigation form (Annex B) records the findings, root cause, corrective and preventive action, whether the incident leads to a field corrective action or a recall in Malaysia, whether it was reported to other regulators, and patient outcome. It must be submitted with a written investigation report or MDA will not accept it. If users or third parties may have erred, review the labelling and instructions for use for inadequacy. When the investigation leads to action in the field, follow MDA’s recall and field corrective action process.

The records that make reporting possible

• Complaint handling (Act 737 s.39, MDA/GD/0011, June 2020): give users a standard complaint form, appoint dedicated personnel, record oral complaints, assess each one for reportability, and keep records for 5 years plus the device’s projected useful life.
• Distribution records (Act 737 s.37, MDA/GD/0012, June 2020): kept for 2 years after supply (or after export shipment), or for the projected useful life if longer. For implants, record the facility, patient where possible and implantation date. These records let you find every affected unit quickly.
• Change of ownership: post-market obligations continue after a model is discontinued. If they move to another company through a merger or acquisition, tell MDA and give it the new contact details as soon as possible.

MDA’s Post Market Division evaluates mandatory problem reports, field corrective action reports and recall reports, and tests devices already on the market. Under MDA/GD/0067 (January 2024), MDA can share information on events that have led, or are highly likely to lead, to a serious public health threat with other ASEAN regulators through the ASEAN Secretariat. A serious incident in Malaysia can therefore reach the regulators in your other ASEAN markets. Distributors also cover complaint and incident handling in their GDPMD quality system.