Reliance: Política de Reliance and Reusable Evidence

1. Key takeaways

On 2025-05-08 the SRS published the Política de Aplicación de Reliance (reference 01.01.02.POL.20250508.01, Versión No. 01, 10 pages). Its Section 6.8 lists the evidence that can be reused for the medical device registration unit (URDM): BPM certificates issued by foreign regulatory authorities, ISO 13485 certificates issued by recognised bodies, MDSAP certificates, conformity certificates issued by EU notified bodies under EU 2017/745 and 2017/746, marketing authorisations issued by foreign regulatory authorities, certificates of free sale (CVL) issued by foreign regulatory authorities, emergency use authorisations issued by foreign regulatory authorities or by the WHO, and certificates of conformity to international standards such as ISO 10993 and IEC 60601-1. Section 6.7 states plainly that reliance is a discretionary power of the SRS and that the final decision always remains with the SRS.

The policy is therefore best understood as a route to a leaner file and a smoother review, not as a substitute for the Salvadoran registration itself. Every item on the Section 6.8 list is a document that already exists in a manufacturer’s regulatory library, which is precisely what makes the policy attractive; but each one is offered to the SRS as evidence, and the SRS decides what weight to give it. Preparing a reliance submission without that asymmetry in mind is the usual reason applicants mistake a discretionary accommodation for an entitlement.

2. Legal basis

The policy sections governing principles, reference authority criteria, eligible evidence and application mechanics are set out below, together with the reliance provision in the technical regulation itself.

3. Expert insights

Insight 1: Reliance is a discretionary power, not a right. Section 6.7 states directly that the implementation of reliance is a discretionary competence of the SRS and that the SRS retains full sovereignty in every case to accept or reject its application. Section 6.6 further preserves the right to request additional information or to carry out a full assessment. The consequence is that invoking reliance can make the file lighter and the review smoother, but it cannot support an expectation of automatic approval. A submission drafted on the assumption that the foreign approval settles the matter will be read as a submission that has not engaged with the local requirements at all.

Insight 2: Of the eight criteria for reference authorities, the first two are the hardest. Section 6.2 requires the reference authority to be on the WHO list of listed authorities (WLA) interim list and to have reached overall maturity level ML3. Those two are objectively verifiable thresholds, whereas the remaining six, covering verifiable web documents, technical track record, process transparency, regulatory cooperation, dedicated legislation, and notified bodies and international standards organisations, are largely qualitative. When submitting a reliance application it is worth stating the WLA and ML3 status of the reference authority explicitly, because those are the two points the reviewer can confirm without exercising judgement.

Insight 3: The evidence list for the device track differs from the one for the medicines track, and the wrong section is easy to cite. Section 6.8 is organised by unit: URDM is the medical device registration unit, URPF is the pharmaceutical registration unit, UEC is the clinical trial unit and UVS is the vigilance unit. When relying on device evidence, only the URDM paragraph should be cited. Importing pharmaceutical items such as bioequivalence certificates or public assessment reports into a device application adds nothing and invites an office action, because those documents answer questions the device unit is not asking.

Insight 4: Reliance does not waive local obligations. The second item of Section 6.6 states that the application of reliance does not relieve the applicant of the duty to comply with all domestic regulatory requirements, including the payment of fees and the submission of technical documentation required locally. So even where an MDSAP certificate has replaced a BPM audit, the registration fee, the annual fee, Spanish-language labelling and the registration of the three local roles all remain due. The saving achieved through reliance is analytical effort, not administrative obligation.

Insight 5: The technical regulation contains its own reliance clause, and the two can be used together. Article 6.1.4 a) allows the authority to recognise and use the decisions, requirements, reports or information of regulatory authorities recognised by PAHO or WHO at Level IV, as well as clinical trials authorised by high-vigilance regulators and by PAHO or WHO. That provision addresses clinical evaluation, and it complements rather than duplicates the device evidence list in the reliance policy.

4. Practical recommendations

• File the reliance application in writing, attaching the registration or change application, the assessment report and approval letter of the reference authority, and complete legalisation as required by Section 6.6.
• State the WLA interim list status and the ML3 maturity level of the reference authority in the application to improve the prospects of acceptance.
• Cite only the URDM paragraph of Section 6.8 for device evidence and keep pharmaceutical track documents out of the file.
• Treat reliance approval as not exempting local obligations: registration fee, annual fee, Spanish labelling and local role registrations still apply.
• Where clinical evaluation is involved, invoke Article 6.1.4 a) on PAHO or WHO Level IV authorities at the same time.
• Verify that the reference authority approval has not been revoked, suspended or modified, as required by the third item of Section 6.6.

5. Verification checklist

• □ Reliance application filed in writing with the official documents of the reference authority
• □ Foreign documents legalised
• □ WLA and ML3 status of the reference authority stated
• □ Only URDM device evidence cited
• □ Local obligations on fees, labelling and roles arranged in parallel
• □ Reference authority approval verified as not revoked or modified

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