Post Market Vigilance and

FSCAs
Malaysia, MDA
• Just as HSA, MDA requires medical device manufacturers
and Authorised Representative to comply with a vigilance
system for post-market monitoring and adverse event
reporting.
• Manufacturer or the AR are obliged by law to report an
adverse event in Malaysia if a medical device has
contributed to one of these outcomes:
• serious threat to public health
• death of a patient, user or other person
• serious deterioration in state of health of patient, user or
other person
• no death or serious injury occurred, but the event might lead
to death or serious injury if it recurs
Reporting of Adverse Events for Medical Devices
• Any AE, which meets the three basic reporting criteria listed
below, is considered as a reportable AE:
• an AE has occurred;
• the medical device is associated with the AE;
• the AE led to one of the following outcomes;
• a serious threat to public health;
• death of a patient, user or other person;
• serious deterioration in state of health, user or other person;
• no death or serious injury occurred but the event might lead to
death or;
• serious injury of a patient, user or other person if the event recurs.
Mandatory Problem Reporting
• An establishment shall report to the Authority any incident that
comes to the establishment’s attention occurring:
• inside Malaysia
• Outside Malaysia (if the device is available in Malaysia market)

• Reporting is done via online form submission on MDA’s website

(link)
Field Safety Corrective Action (FSCA) (including
Recalls)
• Examples of the types of actions that may be considered recalls:
 inspecting the device for problems
 repairing the device
 adjusting settings on the device
 re-labeling the device
 destroying the device
 notifying patients of a problem
 monitoring patients for health issues
Field Safety Corrective Action (FSCA) (including
Recalls)
• A recall is either a correction or a removal depending on where
the action takes place:
 Correction - addresses a problem with a medical device in
the place where it is used or sold.
 Removal - addresses a problem with a medical device by
removing it from where it is used or sold.
Field Safety Corrective Action (FSCA) (including
Recalls)
• MDA classifies medical device recalls into three
categories, reflecting the potential risk to public health:
Class I - High risk
Class II - Less serious risk
Class III - Low risk
• This classification process usually takes place after the
company has issued its recall.
Field Safety Corrective Action (FSCA) (including
Recalls)
• Class I - High risk
 Most serious type of recall. There is a reasonable chance that the product will cause
serious health problems, injury or death.
 Examples of Class I recall :
wrong products (label and contents are different products)
microbial contamination of sterile injectable or ophthalmic product
chemical contamination with serious medical consequences
mix up of some products with more than one container involved
wrong active ingredient in a combination product with serious medical consequences
Field Safety Corrective Action (FSCA) (including
Recalls)
• Class I - High risk
 What should the manufacturer do?
 notify their customers (i.e. distributors) and directs them to notify the intended
recipients of the device (i.e. other distributors, hospitals, other healthcare facilities,
doctors or individual patients). The notification usually contains the name of the
device being recalled, identifying lot or serial numbers, the reasons for the recall,
and instructions about how to correct, avoid, or minimise the problem. It should
also provide a telephone number for questions related to the recall.
 issues a press release to notify the public, if appropriate, to minimise health
consequences.
 MDA may also issue its own press release or public health notice. MDA will also posts
consumer information through its website.
FSCA (including Recalls)
• Class II - Moderate risk
 There is either a possibility that the device will cause temporary or reversible health
problems, or there is remote chance that the device will cause serious problems.
 Examples of Class II recall :
mislabeling e.g. wrong or missing text or figures
missing or incorrect information - leaflets or inserts
microbial contamination of non-injectable, non-ophthalmic sterile product with
medical consequences
chemical / physical contamination (significant impurities, cross contamination,
particulates)
mix up products in containers
non-compliance with specification
insecure closure with serious medical consequences
Field Safety Corrective Action (FSCA) (including
Recalls)
• Class II - Moderate risk
 What should the manufacturer do?
 notify their customers (i.e. distributors) and directs them to notify the intended
recipients of the device (i.e. other distributors, hospitals, other healthcare facilities,
doctors or individual patients). The notification usually contains the name of the
device being recalled, identifying lot or serial numbers, the reasons for the recall,
and instructions about how to correct, avoid, or minimise the problem. It should
also provide a telephone number for questions related to the recall.
 MDA does not issue its own press release or public health notice, through its website. It
doesn’t require the manufacturer to issue a press release to notify the public, as well,
unless there is a specific need to do so.
FSCA (including Recalls)
• Class III - Low risk
 There is little chance that using or being exposed to the device will cause
health problems.
 Examples of Class III recall :
faulty packaging e.g. wrong or missing batch number or expiry date
faulty closure
contamination - microbial spoilage, dirt or detritus, particulate matter
Field Safety Corrective Action (FSCA) (including
Recalls)
• Class III - Low risk
 What should the manufacturer do?
 notify their customers (i.e. distributors) and directs them to notify the intended
recipients of the device (i.e. other distributors, hospitals, other healthcare facilities,
doctors or individual patients). The notification usually contains the name of the
device being recalled, identifying lot or serial numbers, the reasons for the recall,
and instructions about how to correct, avoid, or minimise the problem. It should
also provide a telephone number for questions related to the recall.
 MDA does not issue its own press release or public health notice, through its website. It
doesn’t require the manufacturer to issue a press release to notify the public.
FSCA – Recall Strategy
• Recall strategy (detailed plan) is expected to address the
following elements, regarding the conduct of the recall:
Depth of Recall
Recall Communication
Effectiveness Checks
Stock Control

*For detailed information on these, please refer to the MDA’s Guidance on Product
Recalls on their official webist
FSCA – Elements of A Recall SOP

To be notified and submit a preliminary report

with thorough information about the recall to
MDA, according to recall risk classification

Submit a full detailed report on the recall 2

to 6 weeks after the procedure