Three Grounds for Refusal Under Article 6.3.6

1. Key takeaways

Article 6.3.6 of RTS 11.03.02:21 lists three grounds on which authorisation to market a device may be refused. Ground (a) is the existence of an international health alert that calls into question the quality, safety and efficacy of the device. Ground (b) is conclusive scientific evidence that the device does not meet the requirements of quality, safety and efficacy. Ground (c) is proof that the data and information contained in the application file are false. The three grounds sit in parallel: satisfying any one of them is sufficient for refusal. They are also asymmetric in character, because two of them examine the product and one examines the applicant, and that asymmetry shapes how a file should be prepared.

• Ground (a) turns on an alert that questions the device, so the threshold is doubt rather than a settled finding.
• Ground (b) sets a much higher bar than (a), because it requires conclusive scientific evidence rather than a concern.
• Ground (c) reaches the conduct of the applicant, not the product, which is why its consequences extend beyond the application at hand.
• The safety and alert report filed with the dossier under Article 6.3.2.1 (l) is the natural counterpart to ground (a).
• Import clearance carries a parallel alert check under Article 6.4.1 (d), so the same alert can block both registration and entry.

2. Legal basis

The three grounds are short provisions, but they draw on a defined term and connect to obligations elsewhere in the regulation. The table below records the grounds themselves, the definition of a health alert, the dossier requirement, and the import condition.

3. Expert insights

The first point is that ground (a) and Article 6.3.2.1 (l) form a causal chain. Article 6.3.2.1 (l) requires a safety and health alert report at the time of filing, while Article 6.3.6 (a) allows refusal where an international health alert exists. The relationship between the two is straightforward: the authority checks international alerts on its own initiative during review, and the applicant’s honest disclosure in the (l) report is cooperation rather than self-incrimination. Concealment runs the other way and lands directly on ground (c) as false data and information.

The second point is that the trigger under ground (a) is a question, not a conclusion. The text reads Exista una alerta sanitaria internacional que cuestione, that is, there exists an international health alert that calls into question the device. Article 3.3 defines a health alert as an official communication that restricts or conditions use, which is a narrower measure than withdrawal from the market or a ban. A restrictive notice from a major regulator can therefore be enough to engage ground (a), and a company cannot wait for the alert to escalate before it acts.

The third point is that ground (b) demands conclusive scientific evidence and not suspicion. The provision uses evidencia científica concluyente, which sets a much higher threshold than the questioning standard in (a). That difference leaves room to argue a case. Where the authority raises a concern under (b), the applicant can respond with comparative scientific reasoning instead of simply accepting the conclusion, and the file should be built so that such a response is possible.

The fourth point is that ground (c) carries the heaviest consequence because it goes to integrity rather than to technology. Grounds (a) and (b) address the product, whereas (c) addresses the act of filing. Once data or information in a dossier is found to be false, the effect is not confined to that one application; it bears on the credibility of every later application the company makes. For that reason GRZAN requires every data point in a dossier to be traceable to a source document during compilation, rather than reconstructed at the point of review.

4. Practical recommendations

• Disclose existing international health alerts and the corrective measures already taken in the report required by Article 6.3.2.1 (l).
• Operate an alert monitoring routine: a restrictive notice from a major regulator should trigger an internal assessment rather than waiting for escalation.
• Prepare comparative scientific material in advance so that a challenge under ground (b) can be answered with reasoning rather than concession.
• Make every data point in the dossier traceable to a source document, which removes exposure to ground (c).
• Apply the same alert test at the import stage, where Article 6.4.1 (d) asks whether a valid alert threatens the health of the population.
• Place the three grounds as the final three lines of the dossier self-check sheet, so that each is explicitly answered before filing.

5. Verification checklist

• □ The safety and alert report discloses existing alerts honestly
• □ An alert monitoring routine is in place and triggers internal assessment
• □ Scientific rebuttal material for ground (b) is prepared
• □ Dossier data are traceable to source documents
• □ Alert screening is performed at the import stage
• □ The three grounds appear in the dossier self-check sheet

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Salvadoran market. Our team manages Ministry of Health (MINSAL) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com