Medical Device Post-Market Surveillance (PMS) in Vietnam
Keeping your medical devices safe, compliant, and reliable in Vietnam’s regulatory landscape can be challenging. With Andaman Medical’s expert medical device post-market surveillance in Vietnam, we take the stress off your shoulders by managing the entire process for you. From navigating local regulations to demonstrating ongoing device performance and safety, we ensure your products remain compliant, reliable, and ready for market success.
Medical Device Post-Market Surveillance in Vietnam
The Department of Medical Equipment and Construction (DMEC) under the Ministry of Health (MoH) requires foreign manufacturers to conduct post-market surveillance (PMS) of medical devices in Vietnam, in line with the ASEAN Medical Device Directive (AMDD), which took effect on 1st January 2015. However, each ASEAN member state has flexibility in implementing PMS requirements, and each country has its own specific regulations. Read on to learn how medical device post-market surveillance in Vietnam is specifically implemented in Vietnam.
Why Get Medical Device PMS in Vietnam?
Post-market surveillance is about more than just meeting regulatory requirements—it’s about ensuring patient safety, maintaining market access, and strengthening trust in your brand.
At Andaman Medical, we offer comprehensive PMS solutions to help you navigate Vietnam’s regulatory landscape with confidence. With our deep understanding of local regulations and the medical device industry, we help you ensure your device’s safety and compliance while proactively managing risks, improving product quality, and supporting better patient outcomes.
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.
Why Choose Andaman Medical with the Post-Market Surveillance of Medical Devices in Vietnam
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:
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:
- Handling medical devices that pose serious public health threats or could result in user death.
- Addressing adverse events caused by medical devices that affect user health.
- Product rectification and recall of defective medical devices.
- Disposal of medical devices when the manufacturer or registration holder goes bankrupt, ceases production, or no longer exists.
Documentation for After-Sale Management of Medical Devices in Vietnam
- Letter of Authorization from the medical device owner for organisations applying for circulation.
- Certificate of Warranty from the medical device owner (except for disposable devices or cases where no warranty is required).
- Certificate of Free Sale.
- Logs of adverse events, complaints, and remedial actions, detailing brand/product names, types, quantities, and batch numbers of defective or unsafe medical devices.
- Certificate of Origin.
- Certificate of Quality for each batch issued by the manufacturer.
- Inspection results for medical devices (as required by Decree 98/2021/ND-CP).
- Distribution documents.
Mandatory Reporting Responsibilities
- Suspend circulation of the device.
- Notify the Ministry of Health, distributors, and users in writing, specifying the batch number and defect.
- Prepare plans to rectify or recall the defective batches.
- Report to the Ministry of Health after rectification or recall.
- Inform the licence holder’s website (if applicable) and notify relevant facilities and the Ministry of Health.
- Suspend circulation of the device.
- Conduct investigations to determine the cause.
- Report to the Ministry of Health after receiving investigation results, specifying defects and rectification possibilities. Complete rectification or recall and report back to the Ministry of Health.
- Notify the Ministry of Health.
- Investigate and verify the cause.
- Report to the Ministry of Health, detailing the defects and whether rectification is possible. Complete rectification or recall and report back.
All adverse events must be reported to authorities and medical establishments within 30 days from when the manufacturer, importer, or distributor becomes aware of the event.