Clinical Evaluation and Research: CNEIS Protocol and DNM Opinion

1. Key takeaways

Article 6.1.1 of RTS 11.03.02:21 gives clinical research a dual approval structure. Under item b), the study protocol is evaluated and approved by an independent ethics committee recognised by the competent authority, but the authorisation to conduct the clinical trial is issued by the authority itself, the DNM and now the SRS. The two decisions come from two different bodies and are documented separately.

Article 6.4.2 e) then lists the additional documents required for a special import of investigational products: the protocol authorised by the CNEIS, the favourable opinion issued by the DNM (Dictamen favorable emitido por la DNM), the valid minutes of the protocol authorised by the CNEIS (Acta vigente de protocolo autorizado por el CNEIS) and the inventory of investigational devices authorised by the DNM (Inventario autorizado por la DNM).

• Ethics approval and execution authorisation are separate decisions by separate bodies.
• The ethics committee must be certified by the Ministry of Health and recognised by the authority.
• Four additional documents are required for the special import of investigational devices.
• Investigational devices enter through the special import route, not through ordinary import.
• Sponsor and investigator duties continue after the trial closes.
• Protocol evaluation is the most expensive single item in the file.

2. Legal basis

The dual structure rests on article 6.1.1, on the definition of the independent ethics committee in article 3.12 and on the special import list in article 6.4.2. The table records each provision together with the fee items that apply to protocol review.

3. Expert insights

First insight: ethics approval and execution authorisation are two bodies and two documents. Article 6.1.1 b) assigns the evaluation and approval of the protocol to the independent ethics committee and reserves the authorisation to conduct the clinical trial for the authority, while article 3.12 requires that committee to be certified by the Ministry of Health and recognised by the authority. The four documents listed in article 6.4.2 e), namely the CNEIS protocol, the authority opinion, the minutes and the authorised inventory, are precisely how that dual system appears at the import stage. An applicant holding only one of the two decisions cannot move samples into the country.

Second insight: investigational devices enter through article 6.4.2, not through ordinary import. Article 6.4.2 a) opens with devices intended for scientific research whose protocol has already been approved, and article 6.1.1 d) confirms that import of investigational products must follow both the ethics approval and the authorisation of the study by the authority. The import permit fee under section 7.2 is USD 24.00 for a non-commercial special import, which is a different line from the USD 2040.00 protocol evaluation fee. Both appear in the budget, but under separate headings and at different points in the timeline.

Third insight: the obligations of sponsor and investigator sit in articles 6.1.2 and 6.1.3. Article 6.1.2 d) requires the sponsor to provide the principal investigator with evidence of the quality system under which the device is manufactured, the parameter specifications for storage, transport and final disposal, the investigator brochure, the protocol and any other document required by BPC. Article 6.1.3 b) requires the principal investigator to report deviations, events or incidents in use to the authority and, at the end of the trial, to report the final disposal of remaining, returned or expired investigational products. None of these duties ends when recruitment closes.

Fourth insight: foreign clinical trial data may be reused under article 6.1.4 a). That provision allows the authority to recognise and use decisions, requirements, reports or information issued by regulatory bodies certified by PAHO or WHO at level IV, as well as clinical trials authorised by high vigilance authorities and by PAHO or WHO. Section 6.8 of the reliance policy, in its UEC segment, also lists clinical trials authorised by PAHO level four bodies or by WHO listed authorities as reusable evidence. For Chinese manufacturers that already hold European or American clinical data, this is a substantial practical relief, because the route shortens the evidence chain without replacing the local authorisation step.

Fifth insight: protocol evaluation is the most expensive item in the file. Article 10.1 of the fee schedule prices protocol evaluation at USD 2040.00, far above the registration fee that starts at USD 150.00. Article 10.2 sets the annual renewal or major amendment at USD 60.00. Where a study runs across calendar years, the renewal is filed each year under article 10.2, so the fee table should be modelled over the full duration of the study rather than at its start.

4. Practical recommendations

• Send the protocol to the ethics committee first and apply to the authority for execution authorisation second, since the two steps cannot be combined.
• Route investigational devices through the special import case in article 6.4.2 a) and attach all four documents listed in item e).
• Hand over the quality system evidence, investigator brochure and protocol from sponsor to principal investigator under article 6.1.2 d).
• Report deviations and incidents under article 6.1.3 b), and report final disposal when the trial ends.
• Where foreign clinical data exist, apply for reuse under article 6.1.4 a) and the UEC segment of the reliance policy.
• Budget the USD 2040.00 protocol evaluation fee and, for multi-year studies, the USD 60.00 renewal each year.

5. Verification checklist

• □ Protocol approved by the ethics committee
• □ Execution authorisation obtained from the authority
• □ Four special import documents complete
• □ Sponsor handover list completed
• □ Deviation and incident reporting process established
• □ Evaluation and renewal fees included in the budget

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 3.12, 6.1.1 a), b) and d), 6.1.2 d), 6.1.3 b), 6.1.4 a) and 6.4.2 a) and e); the Política de Aplicación de Reliance (01.01.02.POL.20250508.01, Versión No. 01, SRS website, 2025-05-08), section 6.8 (UEC); and the Tarifario de la Superintendencia de Regulación Sanitaria (2025 edition, published on the SRS website in 2025-10), articles 10.1 and 10.2.

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