EMERGO SUMMARY OF KEY POINTS:

• The Malaysian Medical Device Authority has updated its mandatory problem reporting criteria.
• MDA reporting timeframes have been updated to reflect severity of problems involving medical devices for sale in Malaysia.

Malaysian medical device regulators have updated their criteria for mandatory problem reporting applicable to both domestic and foreign manufacturers registered in the country.

The Malaysian Medical Device Authority’s (MDA) reporting updates were made in early April 2017, but only now announced to Malaysian market registrants.

Updated MDA criteria and timeframes

The MDA has established new reporting timelines based on the severity of an event involving a medical device sold on the Malaysian market.

For an incident involving a device’s failure to operate, decrease in effectiveness or improper labeling or instructions for use, manufacturers, authorized representatives and/or distributors have 30 days from the discovery of the incident to notify the MDA.

For an incident in which use of a device leads to the death or serious injury of a patient or user, the MDA must be notified within 10 days of discovery.

Finally, in cases where use of a device presents a serious threat to public health, registrants must notify the MDA within 48 hours of an incident’s discovery.

The MDA’s announcement also includes a new mandatory problem reporting form.

Related Malaysian medical device market resources:

• Malaysian MDA registration support for medical device companies
• Malaysia Authorized Regulatory Representation for foreign manufacturers
• Whitepaper: Malaysian medical device registration requirements
• Malaysia medical device regulatory process chart