The medtech industry development in Vietnam presents a landscape of profound opportunity, balanced by significant legal challenges. In addition to legal hurdles, companies face significant challenges such as regulatory pressures, supply chain disruptions, and economic uncertainties that can impact their ability to innovate and expand.

For the many international companies entering this dynamic industry, a theoretical understanding of the law is not enough. What they need is a practical roadmap for their business to achieve profitable growth.

From my experience managing client relationships, success in the medtech industry depends on anticipating regulatory shifts and building a compliance framework that protects an investment from day one. This proactive approach turns challenges into a competitive advantage for our client companies.

Key Takeaways:

• A New Legal Era: Law 15/2023 has officially legalized telemedicine, creating mandatory compliance obligations that impact every business in the health sector.
• Software Is a Medical Device: Under new regulations, many software products are now considered a medical device, fundamentally altering the product development lifecycle for medtech companies.
• EMR Mandate: The government’s mandatory roadmap for Electronic Medical Records requires that all medical technology solutions are fully compatible, a critical factor for market viability.
• Data Governance Challenges: The new Data Law 2025 creates a complex legal environment, posing risks for companies that rely on international data flows and cloud infrastructure.
• Market Access Hurdles: Beyond regulatory approval, achieving profitable growth requires navigating pricing rules and an outdated insurance system to ensure new innovative technologies can reach patients. Innovation, adaptation to local market needs, and new healthcare delivery models are driving growth in the medtech sector, propelling the industry forward in Vietnam.

Introduction to MedTech in Vietnam

The MedTech industry in Vietnam is undergoing a remarkable transformation, fueled by rapid advancements in medical technology and a rising demand for innovative healthcare solutions. As one of Southeast Asia’s fastest-growing economies, Vietnam offers a fertile landscape for medical device companies seeking to expand their footprint in the region.

The country’s burgeoning middle class, coupled with an aging population and increased healthcare spending, is driving significant growth across the medtech industry. This momentum is reshaping the healthcare ecosystem, as both public and private sectors prioritize investments that improve patient outcomes and modernize healthcare delivery.

With these favorable conditions, the MedTech sector is poised to play a pivotal role in elevating the standard of patient care and supporting the sustainable growth of Vietnam’s healthcare industry.

A New Framework for the Medical Device Industry

After managing successful projects across Vietnam, it can be affirmed that a deep understanding of the legal framework is the foundation of any successful investment in the medical device industry. The Law on Medical Examination and Treatment (Law 15/2023/QH15) marks a substantial shift.

This legislation impacts not just healthcare providers but also the entire supply chain, forcing companies to rethink their operational models to ensure full compliance. Companies will need to invest in new capabilities, adapt to evolving regulations, and embrace innovation to remain competitive and capitalize on future growth opportunities.

This industry demands foresight, and this law is a clear signal of the direction of future growth.

Understanding Law 15/2023’s Impact on Your Medical Device

The law requires licensed facilities, secure IT infrastructure, and a clear line of professional responsibility for every medical device. This directly impacts the product development process for medtech companies.

From our experience, this is where many companies encounter issues, as it requires a new level of integrated planning. Navigating the evolving legal landscape adds significant regulatory complexity, making compliance with diverse and changing standards like the EU MDR and ISO particularly challenging.

Our role is to help our client companies structure their operations to meet these standards, ensuring their business is built on a compliant and sustainable foundation for growth. This focus on detail is what improves patient outcomes.

Telemedicine: Core Medical Technology in the Medical Device Industry

The legal reality in Vietnam requires a smart approach to innovation. While telemedicine represents a massive opportunity for the health industry, the regulations are detailed.

Companies must focus on their core capabilities to effectively adapt to telemedicine regulations, ensuring they build on essential strengths while navigating compliance. This specific medical technology is now a core part of the medical device industry.

A study published by the National Center for Biotechnology Information (2022) highlighted that while telemedicine adoption is increasing, regulatory adherence remains a key challenge for providers and companies in Vietnam. This is a critical factor for any business planning to enter one of the most promising new markets in the region.

A Full Report on Compliance for this Critical Medical Device

A key insight for companies is that a healthcare facility cannot shift all liability to a technology provider. Here is our full report on the matter: contracts must clearly define who is responsible for what.

This includes ensuring DICOM standards for any imaging medical device and managing clinical responsibility for patients. The regulations are highly specific, requiring data to be stored for at least ten years and mandating detailed consultation minutes for legal traceability.

They even stipulate technical minimums, such as 4 Mbps bandwidth for diagnostic imaging streams and specialized equipment for remote surgery, to ensure quality of care. By building transparent partnerships, we help companies protect their business and ensure their innovation successfully reaches patients and improves patient outcomes.

Software as a Medical Device (SaMD): High Tech Challenges for Every Medical Device

Navigating SaMD Licensing: A Two-Track System

The risk classification of your SaMD (A-D) directly determines your path to market, creating a two-track system. Low-risk Class A and B devices require a simpler declaration dossier filed with the provincial Department of Health.

However, high-risk Class C and D devices need a full registration dossier submitted to the Ministry of Health, which involves a much longer and more rigorous appraisal process. Understanding this distinction is critical for accurate project timelines and budgeting.

The Clinical Trial Hurdle for High-Risk SaMD

For high-risk SaMD, especially those using AI for diagnosis, clinical evidence is non-negotiable. Companies must prepare a comprehensive clinical research dossier that meets Good Clinical Practice standards.

This dossier is reviewed and must be approved by Vietnam's National Ethics Council, often on a strict timeline of around 25 days for review, before trials can even begin.

Post-Market Surveillance for Your Medical Technology

Approval is not the end of the road. The regulations require ongoing post-market surveillance for your medical technology.

This means medtech companies must have robust systems to monitor the performance of every medical device, report adverse events, and manage software updates. Ongoing technology investments are essential to maintain effective surveillance and ensure compliance.

The EMR Mandate: Paving the Way to Become the Largest Medical Device Market

As Vietnam works to become the region’s largest medical device market, the Electronic Medical Record (EMR) system is its digital backbone. According to an official announcement from Vietnam’s Ministry of Health (2024), the mandatory EMR implementation is a national priority for the health industry.

Among the key areas of strategic focus are digital health infrastructure and interoperability, which are essential for supporting the successful rollout of EMR systems.

Integrating Your Medical Device with National Digital Health Infrastructure

For medtech companies, this means any new medical device or platform must be built for interoperability using standards like HL7/FHIR and DICOM. We make this a core part of the product development strategy for our client companies to avoid costly issues later.

This ensures their medical device can integrate seamlessly with healthcare providers across the country, which ultimately improves patient outcomes for millions of patients.

A Full Report on Data Governance in the Medical Device Industry

After years in FDI legal work, I can spot potential problems. Here is a full report on the biggest risk in the medical device industry: data governance.

You have multiple laws creating a complex web of compliance. Investor expectations are increasingly focused on data security, prioritizing these factors when evaluating medtech companies.

Protecting Data from Your Medical Technology

The risk of “duplicate compliance” is real. The new Data Law 2025 introduces ambiguous concepts like 'core' and 'important' data, without clear guidelines yet on classification.

This creates a risk of overlapping authority, where companies may need to report to and be inspected by the Ministry of Health for medical data, the Ministry of Public Security for security, and the Ministry of Information & Communications for data infrastructure. A research article in the International Journal of Environmental Research and Public Health (2021) noted that navigating such overlapping data regulations is a significant hurdle for healthcare innovation.

Protecting data generated by your medical technology is critical. For medical device manufacturers, a secure data strategy is no longer optional.

Market Access and the Push for Constant Innovation in the Medical Device Industry

Sustained growth in the medical device industry requires constant innovation. However, a license is just the first step.

The reality for many companies is that market access is the next major hurdle. The fastest growing segments include robotics, digital healthcare, and cardiovascular health.

Price Declaration and Confidentiality Risks

Adding to market access challenges are new pricing regulations under Circular 29/2024. Companies are now required to declare detailed prices for each specific product model.

From our clients' perspective, a major concern is the risk of exposing sensitive business information and cost structures in a highly competitive market.

Reimbursement Challenges for a New Medical Device

The biggest barrier we see for a new medical device is the outdated insurance reimbursement system. Your cutting-edge medical device might be approved, but if there is no service code for it, patients cannot get it reimbursed through public insurance.

This limits access and slows down growth. New treatment modalities are especially impacted by these outdated reimbursement systems.

Strategies for Profitable Growth in New Markets

This reimbursement gap means medical device companies need smart strategies to achieve profitable growth. We help them build a multi-channel approach, targeting the private market while engaging in policy advocacy to open up public new markets.

This strategic thinking is vital for any business looking for long-term success. A healthy supply chain ensures the technology reaches patients who need it.

IP Strategy for the Modern Medical Technology Industry

The revised IP Law has strengthened patent protections, but a patent alone won’t protect the innovation driving the modern medical technology industry. Medtech leaders play a crucial role in driving comprehensive IP strategies.

Protecting Your Core Medical Technology

We advise companies to adopt a hybrid strategy: use patents for the core medical technology, but rely on robust contracts and cybersecurity to protect the high-value data associated with their medical device. This strategy is what allows the medical technology industry to thrive.

Aligning IP Rights with Clinical Trials

Delays in clinical trials can erode the value of a patent for a new medical technology. We help clients align their IP registration timeline with their clinical trial and market approval roadmap to maximize their return on investment.

Over the past decade, historical trends have shown this alignment is crucial for long-term success. This is a cornerstone of our advisory for medical device companies.

These principles are just the beginning. For companies seeking success in Vietnam’s medtech industry, we have developed comprehensive support systems to navigate this evolving industry and drive sustainable growth.

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Frequently Asked Questions

What is the biggest compliance risk for foreign medical device companies in Vietnam?

In my experience, the biggest risk is the intersection of healthcare and data laws. Many companies focus on getting medical device approval but fail to comply with Vietnam’s strict data localization and personal data protection requirements, which can impact their entire business.

How long does it realistically take to bring a new medical technology to market in Vietnam?

The timeline depends entirely on its risk classification. A low-risk medical device can be on the market in months. However, a high-risk medical technology requiring full registration and clinical trials can take anywhere from 12 to 24 months, a critical consideration for any business plan.

My company uses international cloud servers. Do I really need to store data in Vietnam?

Yes, for certain types of data. Vietnam's Law on Cybersecurity requires that personal data of Vietnamese patients be stored onshore. We advise all our client companies to conduct a thorough data audit and implement a hybrid storage model to ensure full compliance for their health solutions.