Introduction
Vietnam is rapidly emerging as a key medical devices market in Southeast Asia, driven by healthcare modernization, foreign investments, and increased adoption of digital and connected medical technologies. However, entering and operating in Vietnam’s medical device market requires strict adherence to evolving regulatory, quality, and cybersecurity requirements.
End-to-End Medical Devices Regulatory Compliance Assessment Services in Vietnam help manufacturers, importers, and distributors ensure full compliance with Vietnam’s Ministry of Health (MOH) regulations, international quality standards, and global cybersecurity frameworks. With expertise from Cyberintelsys and alignment to CREST-approved security methodologies, organizations can confidently navigate regulatory complexities while safeguarding patient safety and data integrity.
Vietnam Medical Devices Regulatory Landscape
Vietnam’s medical device regulations are primarily governed by:
Ministry of Health (MOH), Vietnam
Decree No. 98/2021/ND-CP on medical device management
Circulars issued by the Department of Medical Equipment and Construction (DMEC)
Device classification (Class A, B, C, D)
Product registration and market authorization requirements
Post-market surveillance and vigilance obligations
Compliance assessments are essential to ensure that medical devices meet Vietnamese regulatory, safety, performance, and cybersecurity expectations before and after market entry.
Why Regulatory Compliance Assessment is Critical in Vietnam
Medical device manufacturers face several challenges in Vietnam, including:
Frequent regulatory updates and procedural changes
Strict documentation and technical dossier requirements
Increased scrutiny on software-based and connected medical devices
Growing focus on cybersecurity, data protection, and patient safety
Penalties, delays, or market withdrawal due to non-compliance
An end-to-end compliance assessment minimizes risks, accelerates approvals, and ensures long-term market sustainability.
End-to-End Medical Devices Regulatory Compliance Assessment Services
1. Medical Device Classification & Regulatory Strategy
Device classification as per Vietnam MOH guidelines
Regulatory pathway analysis for local manufacturing or import
Gap analysis against Decree 98/2021/ND-CP requirements
Customized compliance roadmap for Vietnam market entry
2. Technical Documentation & Dossier Review
Review of technical files and essential principles compliance
Clinical evaluation and performance documentation assessment
Labeling, Instructions for Use (IFU), and UDI compliance checks
Vietnamese language and local regulatory alignment
Cyberintelsys ensures documentation is structured to meet Vietnam MOH expectations while aligning with ISO 13485 and international best practices.
3. Quality Management System (QMS) Compliance Assessment
ISO 13485 QMS readiness assessment
Supplier and manufacturing process compliance evaluation
Risk management alignment with ISO 14971
CAPA and change management review
This ensures seamless regulatory approvals and inspection readiness.
4. Cybersecurity & Software Compliance for Medical Devices
With Vietnam increasingly adopting digital healthcare solutions, cybersecurity is now a critical compliance component.
Cyberintelsys, supported by CREST-aligned security frameworks, provides:
Secure Product Development Lifecycle (SPDL) assessments
Medical device software and SaMD cybersecurity risk analysis
Vulnerability assessment and penetration testing
Compliance with IEC 62304, IEC 81001-5-1, and global cybersecurity standards
Data protection and patient safety impact assessment
These services help manufacturers address cyber risks that could compromise device safety, performance, or regulatory approval.
5. Regulatory Gap Assessment & Remediation
Identification of regulatory non-conformities
Practical remediation plans tailored to Vietnam regulations
Support for corrective actions and documentation updates
Pre-submission readiness checks
This proactive approach reduces approval delays and regulatory rejections.
6. Post-Market Surveillance & Vigilance Compliance
Post-market surveillance system assessment
Incident reporting and vigilance process review
Cybersecurity monitoring and vulnerability disclosure readiness
Periodic compliance audits
Ensuring ongoing compliance is critical for maintaining market authorization in Vietnam.
Why Choose Cyberintelsys for Vietnam Medical Device Compliance?
Cyberintelsys delivers a holistic and integrated compliance approach, combining regulatory, quality, and cybersecurity expertise:
Deep understanding of Vietnam MOH and ASEAN regulatory frameworks
CREST-aligned cybersecurity assessment methodologies
Expertise across hardware, software, and AI-enabled medical devices
End-to-end support from pre-market to post-market stages
Practical, risk-based, and audit-ready compliance solutions
This integrated model helps manufacturers meet regulatory requirements while strengthening trust with regulators, healthcare providers, and patients.
Benefits of End-to-End Compliance Assessment Services
Faster market access in Vietnam
Reduced regulatory and cybersecurity risks
Improved product safety and reliability
Enhanced inspection and audit readiness
Stronger brand credibility and long-term compliance assurance
Conclusion
Vietnam’s medical device market offers significant growth opportunities, but regulatory and cybersecurity compliance are non-negotiable. End-to-End Medical Devices Regulatory Compliance Assessment Services in Vietnam, powered by Cyberintelsys and CREST-aligned frameworks, provide manufacturers with the confidence to enter, operate, and scale in the Vietnamese healthcare ecosystem.
By integrating regulatory expertise, quality management, and advanced cybersecurity assessments, organizations can ensure compliance, protect patient safety, and achieve sustainable success in Vietnam’s evolving medical device landscape.
