Medical Device Post Market Surveillance (PMS) in Vietnam
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.
Medical Device PMS Management for Regulatory Alignment and Market Stability -Vietnam
Navigating Vietnam’s regulatory framework for medical device post-market surveillance requires structured oversight and a clear understanding of local compliance expectations. Once a device is approved and placed on the market, manufacturers and their appointed local representatives must continue to fulfill regulatory obligations under Vietnam’s PMS requirements.
Post-Market Surveillance (PMS) in Vietnam supports the continued safety and performance of medical devices after commercialization. It establishes the processes for complaint handling, incident evaluation, reporting requirements, and corrective action management in accordance with national regulations.
At Andaman Medical, we manage these post-market responsibilities on your behalf. Our team supports compliance with Vietnam’s regulatory framework, maintains structured documentation processes, and coordinates required reporting activities to help keep your products aligned with local requirements.
Why Medical Device PMS Matters in Vietnam
Post-Market Surveillance (PMS) is an important component of Vietnam’s medical device regulatory system, providing continued oversight once a device enters the market.
Manufacturers and local representatives are responsible for maintaining complete records, reviewing reported issues, and fulfilling reporting obligations in accordance with national regulations.
Here’s how Andaman Medical helps you address the challenges of medical device post-market surveillance in Vietnam:
Ensuring Patient Safety
Ensuring Patient Safety
- PMS enables manufacturers and regulatory authorities to detect safety issues early by monitoring real-world device performance.
- It helps identify and address potential adverse events that could impact users’ health.
- Timely corrective actions, such as suspending distribution or recalling defective devices, can be taken to protect patients.
Regulatory Compliance
Regulatory Compliance
- Medical device PMS in Vietnam is a regulatory requirement, as outlined in Decree No. 98/2021/ND-CP on Medical Device Management.
- Licence holders must maintain detailed device history records and follow mandatory reporting procedures.
- Non-compliance can result in import delays or loss of market access.
Quality Improvement
Quality Improvement
- PMS data provides valuable insights into device performance, helping manufacturers identify areas for improvement.
- Analysing PMS data supports informed decisions on product enhancements and updates.
- Addressing issues found through PMS can lead to better product quality and reliability.
Market Access and Competitiveness
Market Access and Competitiveness
- A robust PMS system ensures compliance with evolving regulatory requirements.
- Proactive monitoring and resolving of issues give manufacturers a competitive advantage.
- Positive safety and performance data build trust with healthcare providers and patients.
Ongoing Monitoring
Ongoing Monitoring
- The Infrastructure and Medical Device Administration (IMDA) conducts post-market inspections to ensure the quality of imported and circulated devices.
- PMS activities include inspections, sampling, testing, and adverse event reporting.
- Manufacturers and distributors must report any adverse events or product defects to the authorities.
Medical Device PMS Requirements in Vietnam
The Ministry of Health (MoH) in Vietnam regulates Post-Market Surveillance (PMS) activities for medical devices under Decree No. 98/2021/ND-CP on Medical Device Management, along with amendments in Decree No. 07/2023/ND-CP and Decree No. 96/2023/NĐ-CP. The guidelines cover:
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:
- the handling of medical devices that pose serious threats to public health or could possibly lead to the death of users
- the handling of cases in which medical devices have caused adverse events affecting the health of users
- product rectification and recall of defective medical devices
- the disposal of medical devices whose owners or holders of the product registration number no longer manufacture, go bankrupt or cease to exist.
Documentation for after-sale management of medical devices in Vietnam
License Holders must store the following documents:
- Letter of Authorisation from the owner of the medical device for organisations applying for circulation
- Certificate of Warranty issued by the owner of the medical device, except for disposable medical devices or cases in which warranty services are not required,
- Certificate of Free Sale
- Logs of adverse events, complaints and remedial measures specifying brand/product names, types, quantities and batch numbers of the medical devices involved, especially those that are defective or unsafe for users.
Importers must store the following quality control documents:
- Certificate of Origin
- Certificate of Quality for each batch of the medical device issued by the manufacturer
- Inspection results of medical devices (required for devices specified in Decree 98/2021/ND-CP
- Distribution 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:
- support for your mandatory reporting of Adverse Events and Field Safety Corrective Actions
- identify requirements in medical device directives, standards, and guidance documents to ensure effective implementation of a post-market surveillance system
- evaluate your PMS data to ensure that existing processes and outputs are fully compliant
- monitor and report on any regulatory changes to ensure ongoing compliance
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