Technical Datasheet and Technical Information: Article 6.3.2.1 g) and h)

1. Key takeaways

Article 6.3.2.1 e), g) and h) of RTS 11.03.02:21 require three technical documents in every device dossier: under e), the quality control specification applicable to the device; under g), the device technical datasheet (ficha técnica); under h), the device technical information (información técnica). The three form a sequence of specification, summary and argument. Item e fixes the yardstick against which the product will later be tested, item g gives the reviewer a rapid picture of the product, and item h supplies the evidence that supports the claims made in item g.

Article 5.2.1 c), d) and e) supply the substantive principles behind these documents: the device must perform as claimed by the manufacturer, its performance and safety must not deteriorate within its service life, and it must not be affected by transport, packaging and storage. Each of these principles needs a corresponding piece of evidence in the dossier, and the technical information is where that evidence is normally placed.

The three documents are read together but not interchangeably. A specification without a datasheet leaves the reviewer unable to place the product, a datasheet without technical information leaves every claim unsupported, and technical information without a specification leaves the testing laboratory without a benchmark. Preparing all three from a single source document at the start of the project usually keeps the model numbers, the versions and the parameter values aligned, which is the point most often lost when the parts are drafted separately by different teams.

• Three separate documents are required: quality control specification, technical datasheet and technical information.
• The specification sets the benchmark for later laboratory testing, so vague wording creates later uncertainty.
• The datasheet is a standardised product summary, not an argument.
• The technical information carries design, performance, shelf-life, biocompatibility and sterilisation evidence.
• Service life and transport conditions require their own validation chapters.
• Technical information must be complete enough for an external laboratory to test independently.

2. Legal basis

The three documents sit in the general dossier article, with substantive support in the essential principles and procedural consequences in the testing article. The table sets out the provisions and the specific obligation each one creates for the technical part of the file.

3. Expert insights

First insight: the quality control specification is the benchmark used at sampling. Article 6.5.2 d) provides that devices are evaluated by official national or international standard methods or by pharmacopoeial methods, and article 6.5.2 e) provides that the laboratory issues a result for both conforming and non-conforming products. The specification filed under item e is the reference against which that result is read. The more loosely the specification is written, the greater the uncertainty of the testing outcome, because a limit that cannot be measured cannot be defended. GRZAN drafts specifications down to quantifiable, testable parameters for this reason.

Second insight: the datasheet and the technical information are not interchangeable. In Latin American regulatory usage, the ficha técnica under item g is a standardised product summary covering models, specifications, materials, intended use and packaging. The información técnica under item h is the supporting argument: design verification, performance verification, shelf-life verification, biocompatibility and sterilisation validation. A reviewer uses item g to build a quick mental model of the product and item h to judge whether the evidence is sufficient. Omitting either produces a file in which the product is clearly described but never demonstrated.

Third insight: shelf-life and transport validation deserve their own chapters. Article 5.2.1 d) requires performance and safety not to deteriorate within the service life of the device, and article 5.2.1 e) requires the device not to be affected by transport, packaging and storage. Both principles reappear as additional documents in article 6.3.2.5 c) and d) for other devices and in article 6.3.2.2 b) and c) for IVDs, where a shelf-life or stability technical file and the storage and transport conditions are expressly required. Writing these as dedicated chapters inside the item h technical information covers both the general principle and the category-specific increment in one place, which avoids duplicating the same evidence across several annexes.

Fourth insight: the technical information has to support external laboratory testing under article 6.5.2 b). That provision allows the authority, where it lacks the testing capability, to commission a domestic or foreign external laboratory that has demonstrated technical competence under good laboratory practice and preferably holds accreditation, with the cost borne by the device holder. When the technical information is incomplete, the external laboratory asks for additional samples or additional data, and both the cost and the delay fall on the applicant. A file written for an independent reader, with methods, acceptance criteria and sample preparation described in full, reduces that risk substantially.

The same logic applies to the internal review. A reviewer who cannot reconstruct how a parameter in the datasheet was derived has to ask, and every question restarts a clock. Writing the technical information as a self-contained argument, with the specification cited as the reference and the verification report cited as the proof, keeps the file readable without correspondence and shortens the interval between submission and a substantive answer.

4. Practical recommendations

• Write the quality control specification at the level of quantifiable, testable parameters, because it becomes the benchmark at sampling.
• Prepare the technical datasheet as a summary and the technical information as an argument, and keep them as separate documents.
• Give shelf-life validation and transport validation their own chapters, covering article 5.2.1 d) and e) together with the additional category requirements.
• Make the technical information sufficient for an external laboratory to test independently, avoiding requests for extra samples or data.
• Keep model numbers and version numbers consistent across specification, datasheet and technical information.
• Add fuller performance verification and biocompatibility evidence for Class C and Class D products.

5. Verification checklist

• □ Quality control specification quantified to testable parameters
• □ Datasheet and technical information prepared separately
• □ Shelf-life and transport validation in dedicated chapters
• □ Technical information supports independent external testing
• □ Model and version numbers consistent across the three documents
• □ Supplementary evidence for Class C and Class D complete

The regulations cited in this article are 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), articles 5.2.1 c)–e), 6.3.2.1 e), g) and h), 6.3.2.2 b) and c), 6.3.2.5 c) and d), and 6.5.2 b), d) and e).

Regulatory information verified as at 29 October 2026.

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