Batch release certificates of analysis for imported devices

1. Key takeaways

Article 6.4.1 f) of RTS 11.03.02:21 requires the importer to keep available the batch release certificates of analysis for imported products, and states that these certificates will be requested in the course of health vigilance during the regulatory cycle.

Article 6.5.2 c) elevates the same certificate to one of the three mandatory conditions for quality control sampling. Those three conditions are the technical information on the device, a batch release certificate of analysis issued by the manufacturer stating the regulations relied on, the product specifications and the analysis results, and physical units available for testing in accordance with the current sampling plan.

The obligation is therefore dual in nature. It is a standing documentary duty attached to every imported batch, and it is also the documentary precondition that allows a sampling exercise to proceed at all. A holder that cannot produce the certificate does not merely face a documentation finding; it faces a sampling process that cannot be completed.

2. Legal basis

The certificate requirement, the sampling framework around it and the reliance mechanism that permits reuse of country-of-origin documents are set out below.

The provisions cited in this article are Articles 6.4.1 f), 6.5.1 d) and 6.5.2 a), b) and c) of RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), and Sections 6.7 and 6.8 (ULLBP) of the Política de Aplicación de Reliance (01.01.02.POL.20250508.01, Versión No. 01, SRS website, 2025-05-08).

Regulatory information verified as at 29 October 2026.

3. Expert insights

Insight one: keeping available is a continuing duty of possession, not an action performed at submission. Article 6.4.1 f) uses the formulation that the importer must have available the certificates, and explains that they will be requested during health vigilance in the regulatory cycle. The consequence is that the analysis certificate for every imported batch must be archived and retrievable, and must be capable of being produced on the spot during an unannounced inspection under Article 6.5.1 d). A file that exists only in a supplier’s system overseas does not satisfy a duty of availability that attaches to the importer in El Salvador.

Insight two: the certificate must state three elements, and a missing element makes it incomplete. Article 6.5.2 c) requires the batch release certificate to detail the regulations relied on, the product specifications and the analysis results. A short-form certificate stating only that the batch complies with company standards or that it is conforming does not meet the requirement. The document has to show the test basis, meaning the standard or method applied, the specification limits, and the values actually measured. Reviewers read the certificate against those three elements, and an abbreviated certificate is treated as an absent one.

Insight three: sampling draws two sets of units, an analysis sample and a retention sample, at the holder’s cost. Article 6.5.2 c) provides that sampling takes account of one analysis sample and one retention sample, proportionate to the batch size, while Article 6.5.2 b) makes clear that all testing costs, including testing carried out in a third-party laboratory, are borne by the device holder. Taken together, the cost of a sampling event is not limited to the units withdrawn from stock; it includes the full laboratory charge. Budgeting for sampling on the value of the samples alone understates the exposure considerably.

Insight four: country-of-origin batch release certificates can be reused under the reliance policy. Section 6.8 of the reliance policy, in the ULLBP segment on batch release and laboratory units, lists the items eligible for reuse: the country-of-origin batch release certificate, the analysis report and the brief manufacturing process. For a product that has already completed batch release in China, it is worth attempting to invoke that provision in order to reduce duplicate testing. The same section is subject to Section 6.7, under which the SRS retains the final decision, so reuse is an argument to be made rather than an entitlement to be assumed.

4. Practical recommendations

• Archive batch release certificates of analysis by batch and maintain an index from batch number to certificate that allows immediate retrieval.
• Ensure each certificate states the regulation or method relied on, the specification limits and the actual test results.
• Provide for sampling costs in the budget: two sets of units, one analysis sample and one retention sample, plus the full laboratory charge borne by the holder.
• For products already released by batch in China, assess whether the ULLBP segment of the reliance policy can be invoked to reuse the existing documentation.
• Include the certificate index in the inspection readiness pack, so that it is available for an unannounced inspection under Article 6.5.1 d).
• Agree with the manufacturer that certificates travel with the goods rather than being requested after arrival at port.

5. Verification checklist

• □ Batch release certificates of analysis archived by batch and retrievable on demand
• □ Certificates state the basis relied on, the specification and the results
• □ Sampling units and laboratory fees included in the budget
• □ Applicability of the ULLBP segment of the reliance policy assessed
• □ Certificate index included in the inspection readiness pack
• □ Arrangement with the manufacturer for certificates to accompany each shipment confirmed
• □ Certificates for earlier batches retained rather than discarded after clearance

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