Why Is Registration for Class C and D Medical Devices Still Subject to Additional Requests Despite Complete Documentation?

Introduction

Many businesses preparing for medical device registration for Class C and D medical devices assume that simply submitting all required documents will ensure a smooth licensing process. From a regulatory perspective, the requirements for preparing and evaluating such applications are clearly set out in Decree 98/2021/ND-CP. However, in practice, even companies that follow the prescribed procedures often find themselves caught in a prolonged cycle of requests for supplementation and revision.

This raises an important question: is the real obstacle a lack of documentation, or does it lie in subtle technical details that are not immediately apparent? Could it be that seemingly minor inconsistencies in product classification, intended use, or the way information is presented are, in fact, the underlying factors delaying the approval process?

In the context of increasingly stringent review processes, preparing a well-structured application from the outset is not only essential to optimizing approval timelines, but also serves as a safeguard against potential regulatory risks. In this article, Green NRJ highlights common pitfalls that lead to application delays, helping businesses enhance their chances of approval in a more efficient and effective manner.

The Paradox of Class C & D Medical Device Applications: Why Are Fully Submitted Dossiers Still Not Approved?

In practice, requests for additional documentation often arise not from missing items, but from a misalignment between how the application is structured and the approach taken by the reviewing authority. In other words, an application that is formally complete but lacks logical coherence, consistency, or clarity in reflecting the technical nature of the product is unlikely to pass a rigorous review process.

Notably, these issues are often difficult to identify, particularly for businesses applying for Class C and D medical device registration for the first time. Rather than being concentrated in a single area, such discrepancies are typically scattered across multiple documents, only becoming apparent when the application is reviewed as a whole. This is one of the primary causes of processing delays, often resulting in multiple and sometimes unexpected requests for additional documentation.

Inaccurate Product Classification

Failure to properly define product classification from the outset is often the root cause of repeated application rejections. In practice, reviewing authorities assess applications from a holistic perspective, focusing on the relationships between different versions of the product. If a business fails to clearly demonstrate the linkage between various technical configurations or models, the application may be deemed inconsistent, leading to prolonged and often unexpected review cycles and requests for additional documentation.

As a result, even if individual documents are valid, the application, when viewed as a whole, may lack consistency in reflecting the nature of the product. This misalignment can hinder the reviewing authority’s ability to compare and evaluate the dossier effectively, often leading to requests for clarification, reclassification, or even a complete restructuring of the application. This represents a systemic issue; if not properly addressed from the outset, businesses are likely to face prolonged and resource-intensive review processes.

Inconsistent Intended Use

A complete set of documents may appear comprehensive in terms of its contents; however, if the intended use is not consistently defined, the entire application may immediately be called into question. From the perspective of the reviewing authority, consistency across the product catalogue, technical documentation, instructions for use (IFUs), and quality certifications is a fundamental requirement.

Even minor discrepancies in functional descriptions can undermine the authority’s ability to accurately determine the nature and risk classification of the device. This is a common yet often overlooked issue, frequently requiring businesses to undertake a comprehensive review of their documentation system, resulting in significant time and cost implications.

Unclear Product Catalogue Presentation

Even where the content of the documentation is fully compliant, a poorly structured dossier can become a bottleneck, leading to delays in the review process. Reviewing authorities require a clear and logical flow of information to efficiently determine the product scope and corresponding technical specifications.

However, where the relationships between different components are not clearly articulated, the effectiveness of the assessment may be significantly compromised. While this may not constitute a substantive content issue, a lack of clarity and transparency in presentation can directly disrupt the review process, often requiring businesses to allocate additional time and resources to revise and restructure the dossier from the ground up.

Valid Documentation, Incorrect Format

Even where the professional and legal documentation is complete, failure to comply with formal requirements under current Vietnamese regulations may still result in the immediate rejection of applications for Class C and D medical devices. During the review process, regulatory authorities assess not only the substantive content of the dossier, but also strictly evaluate its formal compliance to ensure overall validity.

Seemingly minor issues, such as non-standardized language, the absence of notarized translations, or discrepancies in the scope of application, are often overlooked by businesses, yet remain mandatory criteria in the review process.

Conclusion

In practice, the rejection of, or repeated requests for revision to, Class C and D medical device registration dossiers rarely stem from a lack of documentation. Rather, they are primarily driven by inconsistencies in how the dossier is constructed, organized, and presented. When key elements, such as product classification, intended use, and consistency across documents, are not carefully controlled, even a formally complete dossier may fail to meet review requirements. Early identification and proper management of these four core issues enable businesses to take a more proactive approach to dossier preparation, significantly reducing the likelihood of repeated requests for supplementation and revision.

If your business is in the process of preparing a submission or looking to review and optimize an existing dossier, Green NRJ is well-positioned to provide expert consulting support. Our team offers comprehensive assessments and helps standardize your dossier in line with the practical expectations of regulatory authorities. Contact Green NRJ today for tailored advice and ensure your application is structured correctly from the outset, maximizing your chances of timely and efficient approval.