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 ANNEX A  
 
ANNEX 5 of the ASEAN Medical Device Directive (AMDD)  
 
Post Marketing Alert System (PMAS) Requirements  
 
1. INTRODUCTION  
 
1.1. Purpose  
 
This document aims to provide guidance on the post -market obligations of persons who place 
medical devices on the markets of ASEAN Member States.  
 
1.2. Background  
 
This document is intended to provide guidelines on the following post - market alerting system 
requirements:  
• Importation and/or distribution records  
• Complaint records  
• Adverse event (AE) reporting criteri a and reporting format  
• Field Safety Corrective Action (FSCA) reporting format  
 
The Regulatory Authorities in the Member States may adopt the recommended post -market 
alerting system requirements in this Annex or prescribe their own post -market alerting syst em 
requirements.  
 
Importation and/or Distribution records  
 
Traceability is not only a requirement of an effective quality system but also the requirement of 
regulatory bodies around the world. Keeping proper and appropriate importation and/or 
distribution records is an important component of ensuring traceability of medical devices in the 
market.  
 
Complaint records  
 
An effective complaint handling system is an important part of any quality system. Any complaint 
received on a medical device should be evaluated and if necessary, thoroughly investigated and 
analy zed, and corrective actions should be taken. The results of the evaluation should lead to a 
conclusion regarding whether the complaint was valid, the causes of the complaint, and what 
actions wer e necessary  to prevent further occurrences.  
 
Dealers of medical devices in the Member State shall be required to:  
• maintain records of complaint reports and of actions taken in response to these reports, and 
produce such records for inspection by the Regula tory Authority in that Member State as 
and when requested; and   
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 • establish and implement documented procedures to conduct  effective and timely 
investigations of reported problems.  
 
Adverse events  
 
A number of post -marketing risk assessment measures to ensure  the continued safe use of medical 
devices may be undertaken. These measures include reporting from healthcare professionals, 
mandatory reporting from medical device dealers, and exchange of regulatory information with 
other medical device regulatory agenc ies. 
 
The mandatory reporting of AEs by medical device dealers is an important part of the post -market 
surveillance system. The objective of AE reporting and subsequent evaluations is to improve 
protection of the health and safety of patients, users and ot hers by disseminating information that 
may reduce the likelihood of, or prevent repetition of AEs, or alleviate consequences of such 
repetition.  
  
Field Safety Corrective Action (FSCA)  
 
A FSCA is required when it becomes necessary for the product owner of the medical device to 
take action (including recall of the medical device) to eliminate, or reduce the risk of, the hazards 
identified.  
 
A FSCA may still be necessary even when the medical device is no longer on the market or has 
been withdrawn but could s till possibly be in use (e.g. implants).  
 
A FSCA only applies to a medical device that has already been distributed by the product owner. 
It does not arise when a product owner is exchanging or upgrading medical devices in the absence 
of a safety risk or w hen removals from the market are for purely commercial reasons.  
 
The product owner, physical manufacturer, authori zed representative(s), importer and/or 
authori zed distributor(s) in the Member State shall be responsible for performing and completing 
the FSCA in that Member State.  
 
1.3. Scope  
 
This document applies to all medical devices, including IVD medical devices.  
 
1.4. Definitions  
 
CUSTOMER COMPLAINT: any written, electronic or oral communication  that alleges 
deficiencies related to the identity, quality,  durability, reliability, safety or performance of a 
medical device that has been placed on the market.  
 
DEALER: any person, which could include the product owner, physical manufacturer, authori zed 
representative or authori zed distributor in a Member State, who has either manufactured, imported, 
placed on the market or put into service a medical device in that Member State.   
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 FIELD SAFETY NOTICE (FSN): A communication sent out by a product owner or its 
representative to the medical device users in  relation to a FSCA.  
 
SERIOUS DETERIORATION IN THE STATE OF HEALTH: any of the  following state or 
condition of a patient:  
• a life -threatening illness or injury suffered by that person;  
• a permanent impairment of a bodily function of that person;  
• any permanen t damage to any part of that person’s body; or  
• a condition requiring medical or surgical intervention to prevent  any such permanent 
impairment or damage.  
 
2. IMPORTATION AND/OR DISTRIBUTION RECORDS  
 
2.1. Responsibility for keeping importation and/or distri bution records  
 
In accordance with the requirements of the Regulatory Authority of each Member State, dealers 
shall:  
• establish and   implement   documented   procedures   for   the  maintenance of importation 
and/or distribution records;  
• maintain an importa tion and/or distribution record of each medical  device.  
 
Importation and/or distribution records should be maintained for all medical devices, including 
low risk medical devices that may be exempted from product registration.  
 
2.2. Necessity of importation  and/or distribution records  
 
Keeping importation and/or distribution records will facilitate the accountability and traceability 
of a medical device. This ensures that the medical device import and/or distribution channels in 
Member States are identifiabl e. 
 
Importation and/or distribution records of the medical devices are required to:  
• expedite any recalls of batches of the medical devices;  
• identify the product owner of each batch of the medical devices;  
• identify where each batch of the medical devices is  supplied.  
 
2.3. Information to be retained as importation and/or distribution records  
 
The importation and/or distribution record should contain sufficient information to permit 
complete and rapid withdrawal of the medical device from the market, where ne cessary.  
Information may include:  
• name and address of initial consignee;  
• identification and quantity of medical devices imported/shipped;  
• date imported/shipped;  
• any control number(s) used, including lot / batch / serial number of  the medical device.  
 
  
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 2.4. Retention period for importation and/or distribution records  
 
The importation and/or distribution record maintained with respect of a medical device should be 
retained for the longer of one of the following:  
• the projected useful life of the medical device  as determined by  
the product owner; or  
• two years after the medical device is shipped.  
 
NOTE: The projected useful life of a medical device may be based on technical, legal, commercial 
or other considerations. Product owners may refer to ISO/ TR 14969 Medi cal devices - Quality 
management systems - Guidance on the application of ISO 13485:2003 for some of the 
considerations when defining the lifetime of their medical device.  
 
For medical devices that are imported for export only, it is two years after the date the medical 
device is shipped out of the Member State.  
 
2.5. Records maintenance  
 
Importation and/or distribution records should be maintained in a manner that will allow their 
timely retrieval.  
2.6. Records of implant  
 
The distribution record maintai ned should also contain a record of the information of the implant 
when supplied by a healthcare facility.  
 
3. COMPLAINT RECORDS  
 
The records on complaints related to a medical device may include the following information:  
• the medical device brand name, me dical device registration number, model/catalogue 
number or bar code, control/serial/ lot number and any other means of identification of the 
medical device;  
• the name(s) and address(es) of the dealer;  
• records pertaining to the problem investigation.  
 
All actions taken by dealers in response to the problems and complaints must be kept on record. 
These actions include any communications with the reporter/complainant, the evaluation of the 
problem/complaint, and any steps taken to correct the problem or preve nt the recurrence of the 
problem. Such steps might include increased post -market surveillance of the medical device, 
corrective and preventive action with respect to the design and manufacture of  the medical device 
affected by the recall.  
 
Attention should  also be given to identifying the development of patterns or trends in problems 
with medical devices. The report of an isolated incident would assume much greater significance 
if other similar occurrences were reported.  
 
  
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 3.1. Complaint handling procedure  
 
Dealers should have in place a written procedure for complaint handling that outlines the steps to 
be taken once a complaint report is received for a medical device placed on the market or put into 
service in the Member State. The procedure should identif y the personnel involved, and describe 
their functions and responsibilities.  
 
In addition, the procedure should explain how to maintain records of the complaint reports, and 
where appropriate, how to assess these records and a reasonable time frame for completion of the 
investigation.  
 
The procedure may contain the following:  
• determination of whether there is a health hazard associated with  the medical device;  
• determination of whether the medical device fails to conform to any claim made by the 
dealer re lating to its effectiveness, benefits, performance characteristics or safety;  
• determination of whether the medical device fails to meet any  legislative requirements;  
• determination of the most appropriate preventive/corrective action;  and 
• justification when  no action is taken, for example, in the case of  receiving an unfounded or 
invalid complaint.  
 
3.2. Retention of complaint records  
 
Complaint records maintained with respect to a medical device should be retained for a period of 
five years on top of the pr ojected useful life of the medical device as determined by the product 
owner. For example, if the projected useful life of the medical device is one year, the complaint 
records should be kept for six years.  
 
4. ADVERSE EVENTS  
 
4.1. Adverse event (AE) repor tability criteria  
 
As a general principle, there should be a pre -disposition to report rather than not to report in case 
of doubt on the reportability of an AE. Any AE, which meets the three basic reporting criteria 
listed below, is considered as a reporta ble AE. The criteria are that:  
• 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 hea lth, 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.  
 
An event or other occurrence relating to a medical device represents a serious threat to public 
health if one or more of the following occur:   
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 • the event or other occurrence is a hazard arising from a systematic failure of the medical 
device that becomes known to the dealer of the medical device;  
• the event or other occurrence may lead to the death of, or a serious  injury to, a patient, a 
user of the medical device or any other person;  
• the probable rate of occurrence of or degree of severity of harm caused by the hazard was 
not previously known or anticipated by the product owner of the medical device;  
• it becomes necessary for the product owner of the medical device  to take prompt action 
(including the recall of the medical device)  to eliminate or reduce the risk of the hazard.  
 
A serious deterioration in state of health can include:  
• life-threatening illness or injury;  
• permanent impairment of a body function or permanent damage  to a body structure;  
• a condition necessitating medical or surgical intervention to prevent permanent impairment 
of a body function or permanent damage to a body str ucture.  
 
Not all AEs that should be reported involve a death or serious deterioration in health that actually 
occurred. The non -occurrence of an adverse effect might have been due to other fortunate 
circumstances or to the timely intervention of health -care personnel. In such cases, it is sufficient 
that either:  
• an AE associated with a medical device happened, and the AE was such that, if it occurred 
again, it might lead to death or serious deterioration in health; or  
• testing, examination of the medical dev ice, information supplied with the medical device, 
or any scientific literature indicated some factor (e.g. a deterioration in characteristics or 
performance, or a shortcoming in the information) which could lead to an AE involving 
death or serious deterio ration in health.  
 
For IVD medical devices, it would be sufficient that:  
• an AE associated with an IVD medical device occurred, and  
• the AE might lead to death or serious deterioration in health if it  happens again;  
• for the adverse event to become reportable . 
 
In assessing the type of AE, medical practitioner involved or other health -care professional should 
be consulted wherever practicable. All persons who place medical devices on the markets of 
Member States should be vigilant for any changes in trends or frequency  of occurrences of AEs 
with regards to medical devices they deal in.  
 
4.2. Adverse events involving IVD medical devices  
 
Most IVD medical devices do not come into contact with patients and so it is not easy to establish 
direct harm to patients, un less the IVD medical device itself causes deterioration in the state of 
health in a patient. However, an adverse event involving an IVD medical device could result in 
indirect harm as a result of an action taken or not taken on the basis of an incorrect re ading obtained 
with an IVD medical device.  
 
There should always be a predisposition to report even though it may not be easy to establish that 
a serious deterioration in the state of a patient’s health was the result of an erroneous test result  
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 obtained with an IVD medical device, or if the harm was the result of an error by the user or third 
party.  
 
Information supplied by the product owner when inadequate, can lead users, patients or third 
parties to harm and should be reported. For self - testing IVD me dical devices, where a medical 
decision may be made directly by the user who is the patient, insufficient information on the 
product presentation could lead to an incorrect use of the IVD medical device or a misdiagnosis. 
Hence, AEs involving IVD medical d evices will most likely result from a consequence of a 
medical decision or action taken, or not taken, on the basis of result(s) provided by the IVD medical 
device.  
 
Examples of these types of AEs include (non -exhaustive list):  
• misdiagnosis;  
• delayed diagno sis; 
• delayed treatment;  
• inappropriate treatment;  
• transfusion of inappropriate materials.  
 
AEs for IVD medical devices may arise due to (non -exhaustive list):  
• shortcomings in the design or manufacture of the IVD medical  device itself;  
• inadequate instruction s for use;  
• inadequate servicing and maintenance;  
• locally initiated modifications or adjustments;  
• inappropriate user practice;  
• inappropriate management procedures;  
• inappropriate environment in which an IVD medical device is used  or stored;  
• selection of the incorrect IVD medical device for the purpose.  
 
4.3. Adverse Event Reporting Timeline  
 
All AEs should be reported immediately and  
 
• not later than 48 hours for events that represent a serious threat to  public health;  
• not later than 10 days for events that has led to the death, or a serious deterioration in the 
state of health, of a patient, a user of the medical device or any other person;  
• not later than 30 days for events where a recurrence of which might lead to the death, or a 
serious deterioration in th e state of health, of a patient, a user of the medical device or any 
other person  
 
The clock for reporting starts as soon as any personnel of the medical device dealers, including 
sales representatives, is made aware of the AE. If there is uncertainty about whether the AE is 
reportable, dealers should still submit a report within the timeframe stipulated.  
 
Dealers should not unduly delay the reporting of AE(s) if information is incomplete. The initial 
report of an AE should contain as much relevant deta il as is immediately available, but should not 
be delayed for the sake of gathering additional information.   
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 Dealers of medical devices are to follow up with a final report within 30 days of the initial reports, 
detailing the investigation into the AE. If t he final report is not available within 30 days, a follow -
up report is to be submitted. Follow -up reports may be requested as and when  necessary.  
 
4.4. Reporting obligations  
 
All dealers shall be required to report AEs involving medical devices, which they  have placed on 
the market in the Member State.  
 
Reports should be submitted using the prescribed format of the Regulatory Authority of the 
Member State, which may follow the ASEAN AE Report Form (Reference No. ASEAN -MDAR).  
 
5. FIELD SAFETY CORRECTIVE ACTI ON (FSCA)  
 
5.1. Determining the need for a field safety corrective action  
 
The product owner of the medical device in question is responsible for determining the need for a 
FSCA. In accessing the need for an FSCA, the product owner should perform a risk as sessment in 
accordance to the current ISO 14971. If the risk assessment performed by the product owner is 
deemed deficient by the Regulatory Authority of the Member State, the Regulatory Authority of 
the Member State may instruct the relevant companies and  persons who placed the medical device 
in the market of the Member State to take additional measures to safeguard public health.  
 
FSCA may be triggered when information from the product owner’s post market surveillance 
(including product complaints, advers e incidents, etc) indicates an unacceptable increase in risk.  
 
On occasions, the Regulatory Authority may advise product owners or their representative to 
implement a FSCA in relation to a medical device due to risk of serious injury or death to patients, 
users or others. Such risks are usually identified through adverse events reports or other means.  
 
In certain cases it may be necessary to use precautionary measures in the interest of public health 
and restrict or prohibit medical devices subject to parti cular requirements. In other cases, for safety 
reasons,  it may be necessary to remove a medical device from the market.  
 
5.2. Notification of field safety corrective action  
 
When the dealer decides to initiate a FSCA, they shall notify the Regulatory Authority.  
 
The time frame for notification of an FSCA shall be prescribed by the  Regulatory Authority of the 
Member State.  
 
All notification and reports are to be submitted in the manner that the  Regulatory Authority 
prescribes.  
 
 
  
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 5.3. Information to be provided  
 
When the need for an FSCA has been established, the dealer should gather all relevant information 
on incident reports, the medical device and its distribution, and the action proposed. Some 
information may not be available immediately (e.g. distr ibution chains, batch size etc). 
Notification to the Regulatory Authority in the Member State should not be delayed pending 
collation of these data.  
 
Reports should be submitted using the prescribed format of the Regulatory Authority of the 
Member State, w hich may follow the ASEAN FSCA Report Form (Reference No. ASEAN -
MDFR).  
 
5.4. Closure of FSCA  
 
On completion of a FSCA, the dealer should provide details to the Regulatory Authority of the 
Member State of the proposed corrective action to prevent recurrence  of the problem that give rise 
to the FSCA.  
 
The FSCA will only be closed when  all appropriate  corrective actions have been undertaken, 
subject to the concurrence of the Regulatory Authority of the Member State.