Quality Control Sampling Under Article 6.5.2: Two Samples, One Bill

1. Key takeaways

Article 6.5.2 of RTS 11.03.02:21 governs quality control sampling through five items, lettered (a) to (e). Under item (a) the competent authority may carry out quality control at any stage of the regulatory cycle, or at the request of an interested party. Under item (b), where the authority lacks in-house capacity it may commission an external laboratory, national or foreign, which must demonstrate technical competence under good laboratory practice and should preferably be accredited; all testing costs, including tests performed at a third-party laboratory, are borne by the device holder. Item (c) requires sampling in accordance with national or international rules in force, with one sample for analysis and one retention sample, proportionate to the batch. Item (d) requires evaluation by official national or international standard methods or by pharmacopoeial methods. Item (e) requires the laboratory to issue an analysis result for conforming and non-conforming product alike.

• Sampling can be initiated at any stage, not only after the device is on the market, and it does not require a complaint as a trigger.
• The holder pays for every analysis, including work carried out in a third-party laboratory abroad.
• Two samples are drawn: one for analysis and one retained, which preserves the possibility of a re-test.
• The laboratory must report a result whether or not the batch conforms, so a silent file is not a satisfactory outcome.
• Testing fees sit in four tiers in the 2025 schedule, which makes the direct cost of a sampling event estimable in advance.

2. Legal basis

The provisions below set out the authority to test, the sampling mechanics, the analytical benchmark and the fee consequences. The quality control specification filed at registration matters here as well, because it supplies the reference against which a sampled batch is assessed.

3. Expert insights

The first point is that sampling does not wait for a complaint and is not confined to the post-market period. Article 6.5.2 (a) is drafted as en cualquier etapa del ciclo de regulación o a solicitud de parte interesada, that is, at any stage of the regulatory cycle or at the request of an interested party. This mirrors the three-stage structure in Article 5.1.1, so the pre-market, market and post-market phases are all exposed to a sampling event.

The second point concerns the design of the sampling. Article 6.5.2 (c) requires una muestra para análisis y otra muestra de retención, one sample for analysis and one retained, and adds that the quantity must be proportionate to the batch. The retained sample is not an accounting formality. It means that where the company disputes the first result, a second set of units exists for verification, which is a meaningful procedural safeguard rather than a courtesy.

The third point is that item (e) is drafted in a way that benefits the holder. The laboratory must issue an analysis result both for product meeting specification and for product failing it. After a sampling event the company is therefore entitled to a written conclusion, and the ambiguous position in which no news is treated as good news has no basis in the text. A passing result should be requested and archived, because it becomes compliance evidence for later changes and for renewal in the same way that an acta does.

The fourth point is that the cost provision reaches beyond the national border. Article 6.5.2 (b) permits commissioning not only a domestic laboratory but also a foreign one, and states expressly that los costos de todos los análisis incluyendo los que se realicen en un laboratorio de tercería, correrán por cuenta del titular del dispositivo médico. Read with the four tiers in section 6.2 of the 2025 schedule, the direct cash outlay for a single event is predictable. Cross-border dispatch adds logistics and elapsed time on top of the fee itself, and that addition is where budgets usually understate the exposure.

4. Practical recommendations

• Treat sampling readiness as standing rather than occasional: the three items in item (c) — technical information, batch release certificate of analysis, and physical units available for testing — should be retrievable at short notice.
• Estimate the testing fee by product category against the four tiers in section 6.2, and add a logistics allowance for cross-border dispatch.
• Request the written result after every sampling event and archive passing conclusions as well as failing ones.
• Where the first result is disputed, use the retention sample to seek verification rather than accepting the finding without challenge.
• Keep the quality control specification filed at registration in quantified, testable terms, since it is the benchmark against which a sampled batch is judged.
• Budget quality control testing costs, borne by the holder, separately from inspection sampling costs, borne by the premises owner.

5. Verification checklist

• □ The three prerequisites for sampling are maintained on a standing basis
• □ Testing fees are estimated by category and include cross-border costs
• □ Written results are actively requested and archived
• □ The retention sample route for verification is understood and allowed for
• □ Quality control specifications remain quantified and testable
• □ The two cost categories are budgeted on separate lines

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