Post Market Surveillance of Medical Devices in Vietnam

The Department of Medical Equipment and Construction (DMEC) of the Ministry of Health (MoH), requires foreign manufacturers to undertake post market surveillance (PMS) in accordance with the ASEAN Medical Device Directive (AMDD) which came into effect on 1st January 2015. However, each ASEAN member state is free in implementing these PMS requirements and each country has its own specificities, please read on to understand how post market surveillance is implemented in Vietnam.

What are the medical device PMS requirements in Vietnam?

The MoH issued guidelines for PMS activities which are regulated for by Decree 36 and Decree 169 regarding medical device management. The guidelines specify:

Documentation for after-sale management of medical devices in Vietnam

License Holders must store the following documents:

Importers must store the following quality control documents:

Mandatory reporting responsibilities

License Holders have varying mandatory reporting responsibilities and actions to be undertaken according to the gravity of the incident relating to their medical device.  

In cases where medical devices harm users' health, license holders are responsible for:

a) suspending circulation of the medical device
b) informing the Ministry of Health, organizations and individuals distributing and using the medical device in writing. The notice must specify the batch number and the defect that pose harm to health of users and whether or not the defect can be rectified
c) preparing plans to rectify or recall batches of the defective medical device
d) reporting to Ministry of Health after completing any rectification or recall.

In cases where medical devices have caused serious threat to public health or the death of users, license holders are responsible for:

a) informing on the license holders’ website (if it exists), sending notice about the adverse event to facilities that trade or utilize the batches medical devices and to Ministry of Health
b) suspending circulation of the medical device
c) conducting investigations and verification to determine the reason for the case
d) reporting to the Ministry of Health after receiving investigation and verification results. In cases where incidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to the Ministry of Health after completing rectification or recall.

In cases where medical devices do not cause death of users but pose serious threats to public health license holders are responsible for:

a) informing the Ministry of Health about the incident
b) conducting investigations and verification to determine the reason for the case
c) reporting to the Ministry of Health after receiving investigation and verification results. In cases where incidents are identified to be caused by defects of medical devices, specify the defects and whether or not rectification of the defects is possible. Rectify or recall batches of defective medical devices and report to the Ministry of Health after completing rectification or recall.

After receiving the relevant report from the license holder, the Ministry of Health is responsible for suspending circulation of the concerned medical device batch(es) or for issuing decisions for the recall of defective medical device batch(es).

What are the timelines for adverse event reporting?

All cases should be reported and informed to authorities and medical establishments within 30 days from the date the manufacturer, importer or distributor is made aware of the adverse event.

How Andaman Medical can help you with post market surveillance in Vietnam

With 6 local offices throughout Southeast Asia, Andaman Medical provides support for your post-market surveillance activities including Adverse Event and Mandatory Reporting. Our local, in-house staff liaise with the Ministry of Health to help you maintain compliance once your medical device is placed on the market. Our services include:

Get a quote on our PMS services in Vietnam

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