Exclusion List and Certificate of Non-Registration: Article 6.3.5

1. Key takeaways

Article 6.3.5 of RTS 11.03.02:21 establishes two exclusion rules. Under item a), the authority publishes an exclusion list (listado de exclusión) in the official media, and products appearing on that list do not require sanitary registration as devices. Under item b), on the application of an interested party, the authority issues a certificate of non-registration (constancia de no registro) for devices that are exempt from the registration obligation. The two provisions together establish that the proposition that all devices must be registered does not hold, while also establishing that the power to decide exemption rests with the authority and not with the company.

The distinction between the two items is procedural rather than substantive. The list is published by the authority on its own initiative, while the certificate is issued on request. A product can therefore be exempt in law and still be unable to demonstrate that exemption at a customs window, unless someone has applied for the document that proves it. This gap between legal status and demonstrable status is where most of the practical difficulty in this area sits.

2. Legal basis

The two exclusion routes, the separate exclusions in Article 2.2 and the certificate fee are set out below.

3. Expert insights

Insight 1: The exclusion list is published, not applied for. The subject of the action in Article 6.3.5 a) is the authority, and the action is publication of the list in the official media. A company therefore cannot apply to have its own product added; it can only check the list at intervals. The GRZAN practice is to make this check a quarterly routine, because the list is updated on a rolling basis and a product that was outside the list at the time of the last review may appear on it later, or the reverse. A dated record of each review is worth keeping for its own sake: if the list later changes, the record shows what the position was when a shipment was planned, which is the only defensible basis for a decision already taken.

Insight 2: The certificate of non-registration is applied for, and it is the document that customs and buyers actually accept. Article 6.3.5 b) is explicit that the certificate is issued on the application of an interested party. Its practical function is evidentiary: where an importer or a procurement department asks why a product carries no registration number, the certificate demonstrates that the product is exempt by law. Without it, a product that genuinely appears on the exclusion list can still be held at clearance or disqualified from a tender, because the exemption exists in the regulation but not in any document the counterparty can read.

Insight 3: Article 6.3.5 and Article 2.2 are two parallel exclusion mechanisms and must both be checked. Article 2.2 excludes products that are governed by their own legislation and products that are not for human use, and its criterion is the legislative status and the intended user. Article 6.3.5 excludes products named by the authority, and its criterion is the list. Neither provision covers the other. A veterinary device is assessed under Article 2.2, while a listed low-risk product is assessed under Article 6.3.5, and a product that fails both tests requires registration.

Insight 4: What is exempted is the registration obligation, not the entire regulatory relationship. The wording of Article 6.3.5 is that such products are exempt from the compulsory nature of sanitary registration. Read with Article 2.1, whose scope extends to non-commercial activities, and with Article 6.5 on vigilance and inspections, a product exempt from registration remains subject to this regulation at the level of import, labelling, vigilance and inspection. Interpreting not registered as not regulated is the most dangerous reading of the article, because it removes exactly the controls that continue to apply. An exempt product that arrives without compliant labelling, or that generates a vigilance signal nobody reports, is in breach in the same way as a registered product would be.

4. Practical recommendations

• Review the exclusion list published by the authority in the official media every quarter and record the date of each review.
• For products confirmed as exempt, apply proactively for the constancia de no registro so that it is available for customs clearance and tenders.
• Assess each product against Article 2.2, on own legislation and human use, and against Article 6.3.5, on the exclusion list, as two separate steps.
• Treat exemption from registration as not exempting the product from import and labelling obligations, and run those processes as normal.
• Archive the exclusion list and the certificate of non-registration together as part of the compliance evidence chain.
• Include the certificate and voucher fee of USD 24.00 under Section 23.1 in the budget.

5. Verification checklist

• □ Exclusion list reviewed quarterly with the review date recorded
• □ Certificate of non-registration obtained for exempt products
• □ Article 2.2 and Article 6.3.5 assessed separately
• □ Import and labelling processes confirmed as continuing for exempt products
• □ Exclusion list and certificate archived together
• □ Certificate and voucher fee included in the budget

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