Malaysia medical device postmarket requirements
Post-market medical device compliance in Malaysia includes renewals, modifications, postmarket surveillance, and vigilance.
Overview of postmarket requirements in Malaysia
Once you have obtained market authorization for your medical device from the Medical Device Authority (MDA) in Malaysia, you must be proactive to maintain regulatory compliance. Postmarket compliance obligations include timely renewals of your device registration, notifying MDA of any changes or modifications to your device, establishing a postmarket surveillance (PMS) system, and reporting adverse events involving your device, also known as vigilance.
Renewals
MDA device registrations must be renewed every five (5) years. Renewal applications should be submitted through the MeDC@St application system up to one year before the expiration date of your current registration.
Modifications
Some device changes or modifications can be implemented via a change notification to MDA while others may require a new registration submission. There are three categories of modifications. Category 1 modifications comprise significant changes that may affect the safety and performance of the device, such as its intended use or risk classification, and require a new registration application. Category 2 modifications require MDA approval before implementation; specific documentation must be submitted via MeDC@St according to the type of modification. Category 3 changes can be implemented as soon as the necessary documentation is submitted to MDA via MeDC@St. Specific documentation and modification scenarios are addressed in MDA’s change notification guidance.
Medical device postmarket surveillance and vigilance in Malaysia
Manufacturers selling medical devices in Malaysia must have a postmarket surveillance system in place to monitor the safety and performance of their device on the market. Postmarket requirements also include vigilance, which requires manufacturers to evaluate, document, and report adverse events involving their medical device registered in Malaysia.
Postmarket surveillance and vigilance requirements are laid out in the Medical Device Act of 2012, Medical Device Regulations of 2019 (link in Bahasa Malaysia), and guidance documents that address required activities. These activities include:
- Distribution Records
- Mandatory Problem Reporting
- Complaint Handling
- Field Corrective Actions (FCA)
- Medical Device Recalls
Mandatory Problem Reporting Timelines for Medical Devices in Malaysia
Incidents involving your medical device must be reported to the MDA. Following the initial report, manufacturers are required to investigate the cause of the incident and conduct field corrective action (FCA), if necessary, to prevent a recurrence. All findings and outcomes of the investigation should be reported to MDA. MDA will review the report and you will receive a written letter from the MDA if the findings and corrective actions are acceptable.
Manufacturers and authorized representatives are obligated to report incidents as soon as they learn of them. Depending on the nature of the incident, reporting must occur within a mandatory timeline:
- within 30 days if the incident is related to the failure of the medical device or a deterioration in its effectiveness, inadequacy in its labeling or Instructions for Use, and the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person.
- within 10 days if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person, but could do so if the incident recurred.
- within 48 hours if the incident is a serious threat to public health.
Frequently
Asked Questions
If an adverse event occurred outside Malaysia, must it be reported to the MDA?
If your device is registered in Malaysia, adverse events must be reported to MDA even if the event occurred outside Malaysia. However, this requirement does not apply if the incident has been reported by the establishment to the regulatory authority in the market where the incident occurred and necessary field corrective action has been taken on all the affected devices in the Malaysian market.
An incident occurred during off-label use. Do we need to report it to the MDA?
No, off-label use incidents do not require a report to the MDA. Incidents of off-label use should be addressed to the healthcare facility where the events occurred.
Do medical device use errors need to be reported to MDA?
Yes and no. Use errors that result in a death or serious deterioration of health, are common or increasing in frequency, or result in an FCA should be reported. Use errors that do not meet these criteria should be addressed within the manufacturer’s quality management system; the event should still be documented along with evidence supporting the decision not to report.
