This guidance document has been adapted from IMDRF/NCAR WG/N14FINAL:2022 (Edition 3) - Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form

ASEAN Medical Device Committee (AMDC) agreed to allow all ASEAN Member States (AMS) to exchange post market information, including information related to significant concerns or potential trends that individual authorities have observed in their jurisdictions, in order to facilitate the AMS in implementing the post market surveillance activities.

Below are the requirements on exchange on the post-market information in which the concerns or potential trends that individual authorities have observed in their jurisdictions to the following:

1. Events leading or highly likely to lead to unanticipated public health threat.

• Reportable events, associated with a medical device that have led or are highly likely to lead to unanticipated serious public health threat and fulfil the following criteria:

1. Death of a patient, user or other person;
2. Serious injury of a patient, user or other person; or
3. 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. Some jurisdictions refer to these events as near incidents.

2. Observations from national trend analysis:

• A trend noticed by an AMS is circulated to the other AMSs s when. :

1. The frequency of the event associated with the device is significantly higher than the frequency recorded in the product owner’s file or significantly higher than the frequency observed with similar devices; and
2. The event has led or is highly likely to lead to a serious public health threat.

 

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References:

POST MARKET INFORMATION EXCHANGE FOR ASEAN MEMBER STATES