Decree 90/2026/ND-CP Takes Effect from May 15, 2026: What Medical Device Businesses Need to Know

Starting from May 15, 2026, Decree 90/2026/ND-CP on administrative penalties in the healthcare sector will officially take effect, introducing several important regulatory updates. Among the areas receiving increased attention, medical devices are expected to face stricter oversight in relation to classification, circulation registration, labeling, and post-market management. These changes are likely to place greater compliance pressure on manufacturers, importers, and distributors operating in the medical device industry.

Medical devices are becoming a stronger focus under healthcare compliance regulations

Although Decree 90/2026/ND-CP applies broadly to the healthcare sector, businesses involved in medical devices are expected to experience a more noticeable impact due to tighter post-market supervision and compliance requirements.

In the past, many companies mainly focused on obtaining circulation approval in order to place products on the market. However, regulatory authorities are now paying closer attention to whether products remain compliant throughout their entire lifecycle, from registration and importation to distribution and actual market use.

As a result, businesses are no longer evaluated only based on initial documentation. Authorities are increasingly reviewing the consistency between legal dossiers, product information, quality management systems, and real-world product usage.

Key areas currently receiving stronger regulatory scrutiny include medical device classification, circulation registration dossiers, labeling requirements, instructions for use, and post-market surveillance activities.

With inspections and post-market reviews becoming more frequent, companies that proactively review their internal procedures and regulatory documentation will be in a better position to reduce compliance risks.

Medical device classification directly affects the entire regulatory process

One of the most closely monitored areas is the accuracy of medical device classification.

Classification serves as the foundation for determining the applicable registration pathway and regulatory requirements for a product. If a device is classified incorrectly in terms of risk level or intended use, the entire circulation registration process may be affected.

In practice, many companies still encounter issues because classification results are not fully aligned with technical documentation or actual product functions. During inspections, these inconsistencies can lead to requests for clarification, dossier revisions, or regulatory penalties.

Under the current regulatory trend, classification is no longer treated as a simple administrative formality. Authorities increasingly expect businesses to provide clear technical justifications and ensure consistency between classification documents and the products being circulated in the market.

For companies handling multiple product categories, conducting an early review of classification results can significantly reduce future compliance risks during registration and post-market activities.

Circulation registration dossiers now require greater consistency and transparency

In addition to classification, circulation registration dossiers are also becoming a major focus of regulatory review.

Many businesses still face challenges related to incomplete technical documentation, inconsistencies between submitted documents, or insufficient evidence regarding product quality and safety. These gaps may result in penalties or requests for additional documentation during inspections.

Beyond circulation licenses, authorities are also placing more emphasis on quality management systems, technical files, and supporting documents related to product origin, intended use, and technical specifications.

As regulations continue to tighten, maintaining well-organized and consistent dossiers is becoming increasingly important, not only for registration purposes but also for reducing pressure during future post-market inspections.

For companies with products already available on the market, regular dossier reviews can help identify compliance gaps early and minimize potential legal risks.

Labeling and Vietnamese instructions for use are receiving closer attention

Another area attracting increased regulatory attention involves product labeling and Vietnamese instructions for use.

In practice, many companies still encounter issues such as missing warning information, incomplete instructions, or inconsistencies between labeling content and approved registration dossiers. In some cases, translated content may not fully reflect the original product information.

For medical devices, instructions for use are considered essential documents directly related to product operation and user safety within healthcare facilities. As a result, authorities are strengthening oversight of this area to reduce risks arising during practical use.

Businesses should ensure that all labeling information and Vietnamese instructions for use are clear, complete, and fully aligned with the approved regulatory documentation of the product.

Post-market surveillance is becoming a mandatory responsibility for medical device businesses

Regulatory management is no longer limited to the circulation approval stage. Authorities are increasingly extending oversight to products after they have entered the market.

Under this approach, businesses are expected to monitor product quality, collect customer feedback, and implement appropriate corrective actions when issues involving medical devices arise.

At the same time, regulators are paying closer attention to how companies maintain post-market records, technical documentation, and internal procedures related to handling product incidents.

Although post-market surveillance was previously overlooked by many businesses, it is now becoming a critical factor affecting long-term regulatory compliance and operational stability.

Establishing a structured post-market management system not only helps reduce legal risks but also improves overall product quality control in the marketplace.

Higher penalties are creating greater compliance pressure for businesses

Under Decree 90/2026/ND-CP, penalties for violations related to medical devices have increased significantly, ranging from VND 500,000 to VND 100 million depending on the nature and severity of the violation.

In addition to administrative fines, businesses may also face supplementary sanctions such as suspension of licenses or professional certificates for periods ranging from 1 to 24 months, suspension of business operations, or confiscation and recall of non-compliant products and documents.

The stronger penalties clearly reflect the government’s intention to increase accountability and strengthen compliance enforcement throughout the medical device lifecycle.

As regulations continue to become more stringent, companies that have not yet standardized their documentation or established proper internal compliance systems may face increasing operational pressure.

Green NRJ supports businesses with medical device regulatory compliance

In light of the changes from Decree 90/2026/ND-CP, medical device businesses need to proactively review their legal documents, registration for circulation, label content, and post-marketing management activities to minimize risks during business operations. Green NRJ partners with businesses by providing consulting services on medical device classification, registration for circulation, and support in completing documentation in accordance with current regulations. Contact Green NRJ for advice on suitable solutions and optimized legal processes for your business.