Medical device registration post-inspection: Why businesses must stay vigilant

Medical device post-inspection: Why businesses fail to stay compliant

Many businesses assume that receiving a medical device registration number means full compliance has been achieved. In reality, post-inspections can expose critical discrepancies in documentation that had gone undetected.

Recently, regulatory authorities have begun reviewing licenses issued 3–5 years ago. This is also when many businesses are caught off guard, not because their original dossiers were incomplete, but because the approved documentation no longer aligns with the actual products currently on the market.

The issue is not whether a license has been granted, but whether the business can maintain ongoing compliance with its documentation over time.

So, when a post-inspection is conducted, what exactly do regulatory authorities examine, and how should businesses prepare to avoid the risk of suspension or revocation?

Post-market surveillance of medical devices: What it is and how it is being tightened

Post-inspection is not a new requirement under the current legal framework, having been introduced in Decree No. 98/2021/ND-CP. What is changing, however, is the clarity and strictness of its implementation, highlighting that a granted registration number does not make a dossier permanently “fixed.”

The problem is that, throughout the product lifecycle, many businesses fail to update their documentation after obtaining a registration number. Over time, this gradual “mismatch” is what makes the dossier vulnerable during post-inspection.

In such situations, businesses are not only required to provide explanations but may also face suspension or even revocation of their registration number if they cannot demonstrate the validity and consistency of their documentation.

During a post-inspection, what aspects of the dossier are reviewed by regulatory authorities?

The post-inspection process extends beyond verifying documentation completeness to assessing the alignment between legal records and the product in circulation. The critical factor is whether the dossier accurately represents the product at the time of inspection.

In practice, regulatory authorities may require businesses to review and update all technical documentation, including CFS, ISO, and IFU, and to cross-check these against product labels, catalogs, and the products currently in circulation. Seemingly minor details, such as model, intended use, or classification, can become critical points of review if inconsistencies arise.

This multi-faceted review process poses challenges for many businesses, as documentation that was valid at the time of submission may no longer reflect reality after a period of operation.

Why do outdated records become a key vulnerability during post-inspection?

Typically, a product lifecycle can span 3 to 5 years. During this time, manufacturers often make adjustments to improve the product or adapt to market demands. These changes may seem minor, such as modifying technical specifications, updating the IFU, changing packaging, or even upgrading the model.

If these changes are not updated in the approved circulation records, discrepancies will inevitably arise. During post-inspection, such inconsistencies can lead to significant legal risks. The pressure to provide explanations is further intensified if the business does not maintain complete records or encounters difficulties in obtaining updated documents from the manufacturer within a limited timeframe.

What are the potential risks for businesses when discrepancies are found during post-inspection?

When discrepancies are detected, regulatory authorities may require the business to provide explanations or update its records. In many cases, they may also impose stricter measures, such as temporary suspension of circulation or revocation of registration numbers, if the business fails to promptly demonstrate the validity of its documentation.

The impact goes beyond legal risks and directly affects business operations. The inability to import or distribute products can disrupt the supply chain and significantly undermine business plans.

In the long term, failure to address post-inspection issues promptly and transparently can significantly undermine a company’s reputation in the market.

What preparations should businesses make now to avoid being caught off guard during post-inspection?

As post-inspection activities become increasingly widespread, reviewing previously issued registration numbers is no longer optional but a necessary requirement for businesses to maintain stable operations.

Businesses need to ensure that all current legal documentation, including product labels, catalogs, and IFU, accurately reflects the products currently on the market. Even minor discrepancies can become risk factors during post-inspection.

In addition, the validity of documents such as CFS, ISO, LOA, and device classifications should be reviewed periodically, rather than only when requested by regulatory authorities.

More importantly, businesses need to shift their perspective: obtaining a product registration number is not the end point, but the beginning of a continuous compliance process throughout the product lifecycle.

Conclusion

Post-inspection of medical device registration numbers is no longer a possibility, but is becoming a routine regulatory activity.

If a business holds registration numbers issued within the past 3–5 years but has never reviewed its documentation, now is the time to do so before being subject to post-inspection.

Green NRJ offers end-to-end support in reviewing medical device documentation, detecting inconsistencies between dossiers and products in circulation, and recommending tailored solutions for each case, enabling businesses to manage risks and maintain long-term compliance.