Medical Device Post-Market Review: Vietnam Strengthens Oversight of Medical Device Administrative Procedures (2026)

Introduction

Medical device post-market review has become an increasingly important focus of regulatory oversight as authorities continue to strengthen quality management for medical devices available on the market. In addition to completing administrative procedures, businesses are expected to maintain ongoing compliance throughout the manufacturing, distribution, and commercialization of their medical devices. Understanding the latest regulatory requirements will help companies better prepare for inspections while minimizing potential legal and compliance risks.

The Ministry of Health Strengthens Inspection and Post-Market Review of Administrative Procedures for Medical Devices

On 16 June 2026, the Ministry of Health issued Official Dispatch No. 4438/BYT-HTTB, requesting provincial and municipal Departments of Health to strengthen inspections and post-market reviews of administrative procedures relating to medical devices in accordance with Decree No. 98/2021/ND-CP and Decree No. 148/2025/ND-CP. The issuance of this official guidance reflects the Ministry’s continued efforts to reinforce regulatory oversight beyond the initial approval stage. Rather than focusing solely on the completeness of submitted applications, regulatory authorities will now place greater emphasis on whether manufacturers, importers, and distributors continue to comply with legal requirements throughout the entire lifecycle of their medical devices. This enhanced post-market review mechanism is also intended to improve market supervision, ensure that medical devices meet applicable standards for quality, safety, and traceability, and promote a more transparent and compliant business environment across the healthcare sector.

Which Administrative Procedures Will Be Subject to Post-Market Review?

According to the Ministry’s latest guidance, post-market review activities will apply to administrative procedures processed by provincial Departments of Health through the Medical Device Management Information System. These procedures include declarations of eligibility for medical device manufacturing, declarations of applicable standards for Class A and Class B medical devices, declarations of eligibility for trading Class B, C, and D medical devices, declarations of narcotic or precursor concentrations contained in raw materials used for manufacturing medical devices, as well as applications for Certificates of Free Sale (CFS) for Class A and Class B medical devices. The inclusion of these procedures within the scope of post-market review highlights an important regulatory principle: a company’s compliance obligations do not end once an administrative procedure has been completed. Businesses are expected to continuously maintain the conditions declared in their submissions and be prepared to demonstrate ongoing compliance whenever requested by the competent authorities.

What Will the Post-Market Review Focus On?

One of the most significant aspects of this strengthened regulatory approach is that post-market review will extend well beyond a simple administrative document check. Instead, authorities will assess whether businesses consistently comply with applicable regulations throughout the manufacturing, distribution, and commercialization of medical devices. As an initial step, inspectors will examine whether declaration dossiers remain complete, legally valid, and effective. This review helps determine whether the products currently available on the market continue to satisfy all applicable regulatory requirements.

Technical documentation will also undergo detailed assessment. Depending on the product, this may include technical specifications, intended purpose, indications for use, instructions for use, product labels, clinical evaluation reports, and legal documentation relating to imported medical devices. Regulatory authorities will compare these documents with the actual products in circulation to verify that the declared information accurately reflects the characteristics and intended use of the devices.

In addition, medical device classification results will be reviewed to determine whether they comply with the requirements set out in Circular No. 05/2022/TT-BYT. For domestically manufactured medical devices, inspectors will also assess whether applicable quality evaluation requirements have been fully satisfied before the products are placed on the market.

Beyond documentation, the post-market review will also examine manufacturing facilities, business operations, storage conditions, transportation practices, product traceability, and records relating to the use of medical devices. These inspections enable regulatory authorities to evaluate whether businesses continue to maintain the conditions originally declared during the administrative approval process. Taken together, these measures demonstrate that post-market review has evolved into a comprehensive compliance assessment rather than a one-time verification of administrative documents.

Stronger Inter-Agency Cooperation to Address Regulatory Violations

Alongside the strengthened post-market review activities, the Ministry of Health has instructed provincial Departments of Health to work more closely with the Market Surveillance Authority, the Police, Customs, and the National Steering Committee against Smuggling, Commercial Fraud and Counterfeit Goods (Steering Committee 389) to detect and address violations involving medical devices. This coordinated approach is intended to promptly identify and prevent the manufacture and distribution of counterfeit medical devices, products without valid circulation numbers, devices of unknown origin, and products that fail to meet quality requirements prescribed by law.

Violations will be handled in accordance with Decree No. 90/2026/ND-CP. Depending on the nature and severity of the violation, businesses may be subject to administrative penalties, suspension of operations, product recalls, or mandatory destruction of non-compliant medical devices. By strengthening cooperation among regulatory authorities, the Ministry aims to enhance market supervision, improve regulatory enforcement, and ensure that only compliant medical devices remain available on the Vietnamese market.

How Should Businesses Prepare for Post-Market Reviews?

As post-market review activities become increasingly rigorous, businesses should proactively review all previously submitted dossiers to ensure that the information remains valid, accurate, and consistent with the products currently being manufactured, imported, or distributed.

In addition to maintaining complete legal documentation, companies should regularly update and retain technical documentation, quality records, certificates of origin, and all records related to manufacturing, distribution, storage, transportation, and product traceability. Maintaining comprehensive documentation will enable businesses to respond promptly and effectively when requested by regulatory authorities.

More importantly, compliance should not be viewed as a one-time requirement that ends after administrative approval has been obtained. Businesses are expected to maintain complete, lawful, and consistent technical, legal, and quality documentation throughout the entire commercial lifecycle of each medical device. Establishing and maintaining a robust documentation management system from the outset is one of the most effective ways to reduce regulatory risks and avoid potential compliance issues during inspections and post-market reviews.

Green NRJ Supports Businesses in Preparing for Medical Device Post-Market Reviews

As regulatory oversight continues to evolve, Green NRJ helps businesses strengthen their compliance readiness by reviewing declaration dossiers and product registration documents before post-market reviews take place. Our team also provides professional consulting services for technical documentation compliance assessments, medical device classification, declarations of applicable standards, medical device registration, and applications for Certificates of Free Sale (CFS). Each service is delivered in accordance with the latest regulatory requirements to help businesses navigate complex compliance procedures with greater confidence.

In addition, Green NRJ supports businesses in addressing issues that may arise during inspections, regulatory audits, and post-market reviews by providing practical compliance solutions tailored to each specific situation. With thorough preparation and continuous regulatory support, businesses can significantly reduce compliance risks while ensuring that their products remain fully aligned with Vietnam’s medical device regulations.

Conclusion

Medical device post-market review is becoming an increasingly important component of Vietnam’s regulatory framework for medical devices. Businesses are expected not only to complete administrative procedures correctly but also to maintain complete legal, technical, and quality documentation throughout the entire lifecycle of their products.

If your company requires assistance with dossier reviews, medical device registration, declarations of applicable standards, or preparation for regulatory inspections and post-market reviews, Green NRJ is ready to support your compliance journey with practical solutions tailored to your business needs and aligned with the latest regulatory requirements.