Solution to “Unblock” Fast-Track Marketing Authorization for Contact Lens Solutions

Contact lens solution registration in Vietnam (including cleaning, rinsing, storage, and moisturizing solutions) has become a bottleneck that prevents many importers—particularly those sourcing from Korea—from utilizing the fast-track pathway for medical device registration. A considerable number of applications, despite being thoroughly prepared, still face prolonged processing times, disrupting business plans and delaying product launches.

In many cases, the issue does not stem from missing documentation, but rather from a misinterpretation of product classification and the eligibility criteria for the fast-track pathway for medical devices. Looking at the process as a whole, even a slight misstep at the initial stage can cause the entire procedure to stall, making it nearly impossible to achieve the expected speed thereafter.

Why Contact Lens Solution Registration in Vietnam Gets Stuck

During Green NRJ’s support for businesses registering contact lens solutions, a common thread emerged: many companies chose to import from South Korea due to brand recognition and quality. However, when it came time to register, the applications didn’t process as quickly as expected. Initially, most businesses attributed the problem to incomplete documentation. But upon closer examination, the cause wasn’t technical in document preparation, but rather the legal nature of the product in the two countries. This leads to a more important question: could the different classifications of the same product be the “bottleneck” preventing applications from being processed quickly?

Differences in Classification Between Vietnam and Korea

Looking deeper into the regulations, a clear “misalignment” between the two regulatory systems can be seen. In Korea, contact lens solutions are classified as Quasi-Drugs—a category between pharmaceuticals and cosmetics. Therefore, the Certificate of Free Sale (CFS) is issued under this specific framework. Meanwhile, in Vietnam, the product is classified as a Class C medical device. This is not merely a difference in terminology, but leads to completely different requirements for marketing authorization. As a result, even though the product is legally marketed in Korea, the accompanying CFS does not meet the conditions of the fast-track mechanism in Vietnam. From this point, the issue is no longer “what is missing in the dossier,” but “whether the dossier meets the conditions for fast-track review.”.

Conditions for Applying the Fast-Track Pathway for Medical Devices in Vietnam

At a glance, the fast-track pathway is often understood simply as a shortened processing time. However, its nature is based on the recognition of reference countries and legal compatibility between regulatory systems.

In other words, a dossier can only go through the fast-track pathway when:

• The product has been approved in a reference country
• The approval is consistent with Vietnam’s classification
• The dossier demonstrates sufficient regulatory compatibility

If any of these conditions are missing, the dossier will not be processed under the fast-track pathway, and the timeline may be significantly longer than initially expected.

When placing Korean contact lens solutions in this context, a gap becomes clear: the CFS issued under the Quasi-Drug category does not fall within the framework that Vietnam applies to Class C medical devices. Therefore, the inability to proceed via the fast-track pathway is not an exception, but almost an inevitable outcome if the approach is not adjusted.

Solutions to Enable Fast-Track Processing from the Beginning

Once the bottleneck is identified as lying in the legal framework, the solution is no longer about revising the dossier, but about reconsidering product sourcing or selecting a more suitable manufacturer. This is an important shift: instead of “trying to complete the existing dossier,” businesses need to reassess from the beginning to ensure the dossier is eligible for fast-track processing. In practice, Green NRJ typically advises two main approaches depending on the business’s goals and strategy.

Solution 1: Adjust Import Source to Meet Fast-Track Conditions

One approach that many businesses are adopting is switching to manufacturers in China that have been approved by the NMPA. Notably, this regulatory system shows a higher level of compatibility with Vietnam’s requirements in certain cases, allowing dossiers to qualify for fast-track review. When applying this option, the registration process often becomes clearer and more controllable. Processing time, if no additional requirements arise, can be reduced to just a few months. However, this does not mean all products automatically qualify. The manufacturer’s dossier still needs to be carefully evaluated, especially the core legal documents.

Solution 2: Retain Korean Sources but Adjust Manufacturer Selection Criteria

If businesses still prefer sourcing from Korea, the approach is not to abandon it entirely, but to change the criteria for selecting manufacturers from the outset.

Specifically, priority should be given to manufacturers that:

• Have a CFS issued by a reference country (such as the US, EU, etc.)
• Maintain documentation aligned with international standards
• Have experience exporting to highly regulated markets

The difference lies in selecting based on the ability to meet Vietnam’s legal requirements, rather than relying solely on commercial factors. Without this step, the risk of delays or failure to meet fast-track conditions is almost unavoidable.

From Solutions Back to the Core Issue: Getting It Right from the Start

Looking back at the entire process of registering contact lens solutions, it can be seen that most difficulties do not actually come from legal regulations, but from businesses starting at the wrong point. When product classification is not carefully verified, when the CFS framework is not fully aligned, and when the conditions of the reference country are not thoroughly assessed, delays in the dossier are almost predictable. On the other hand, if these factors are reviewed at the preparation stage, the registration process becomes more proactive and significantly reduces risks during dossier processing.

Conclusion

Registering contact lens solutions will no longer be a “bottleneck” if businesses clearly understand fast-track conditions and make the right choices from the beginning. The evaluation of the product, manufacturer, and legal framework should be carried out simultaneously, rather than only after the dossier has become stuck. Green NRJ accompanies businesses from product assessment and manufacturer selection to completing the medical device registration dossier. If a clear and feasible direction is needed from the start, this is the right time to begin the process correctly.