Seven Establishment Authorisation Documents and Floor Plan Approval

1. Key takeaways

Article 6.2.2 a) of RTS 11.03.02:21 lists 7 documents for the establishment authorisation: 1) floor plan approval, limited to manufacturing and conditioning establishments; 2) a layout drawing of the premises stating the total area in m²; 3) a location sketch of the site (croquis); 4) a completed application form, with legal persons also required to attach proof of legal existence and valid credentials of the legal representative; 5) the original contract of the Director Técnico; 6) the Director Técnico registration form together with the payment receipt; and 7) the original valid professional practice certificate issued by the corresponding professional oversight board (Junta de Vigilancia de la Profesión).

Three of the seven items depend on a person who has not yet been hired in most first-time projects, which is why the file is usually assembled in the wrong order. The document set is not a checklist of paperwork to be collected from a filing cabinet; it is the evidence that the establishment has premises, a lawful representative and a qualified technical director in place at the moment of filing. Where any of those three is unsettled, the application has nothing to attach.

2. Legal basis

The seven documents, the roles they presuppose and the fees attached to the review steps are set out in the following provisions.

3. Expert insights

Insight 1: Three of the seven documents are tied directly to the technical director. Items 5, 6 and 7 are the original contract, the registration form with its payment receipt, and the original practice certificate. The consequence is that if the technical director has not been appointed, the establishment file cannot be lodged at all. This is the most common blocking point for Chinese device manufacturers entering El Salvador, because recruitment is often deferred until the product file is nearly ready. The GRZAN practice is to secure the technical director before the premises lease is signed, so that the contract and the registration formalities run in parallel with the fit-out rather than after it.

Insight 2: Floor plan approval applies only to manufacturing and conditioning establishments. The first item of Article 6.2.2 a) is expressly framed as applying where the establishment carries out device manufacturing or conditioning, which is when the plan approval procedure (trámite de aprobación de planos) is required. A pure importer, storage centre or distributor does not need this item. The layout drawing in item 2 and the location sketch in item 3, by contrast, apply to every category without exception. Separating the two groups of requirements at the planning stage saves a considerable amount of time, because the plan approval is the only item in the list that involves a technical review of the premises rather than a documentary check.

Insight 3: Floor plan review is a separately priced item, and a relocation or a remodelling triggers it again. Section 11.6.1 of the tariff prices the review of floor plans for new facilities, relocation, or remodelling of the infrastructure of a manufacturing laboratory at USD 240.00. Read together with Article 6.2.3, under which a relocation or a change of infrastructure requires prior approval, a single relocation therefore triggers both the plan review fee and the relocation fee under Section 11.4.3, which for a device importer stands at USD 72.00. A move that is treated internally as an address update is in fact two separate applications with two separate fees.

Insight 4: The practice certificate must come from the corresponding professional oversight board and must be the original. The last item of Article 6.2.2 a) requires the original valid practice certificate issued by the Junta de Vigilancia de la Profesión, while Article 3.13 requires the CSSP practice licence as a separate qualification layer. Both are needed, and neither substitutes for the other: the CSSP licence establishes the right to practise, and the board certificate evidences it in the form the authority accepts. Article 6.3.1 e) further requires documents already submitted in a file to remain valid, so an expired practice certificate is not merely a stale document but a defect in the registration itself.

4. Practical recommendations

• Secure and contract the Director Técnico before starting the establishment application, because three of the seven documents depend on that appointment.
• Obtain floor plan approval in addition for manufacturing and conditioning establishments; pure import and distribution establishments can omit this item.
• Mark the total area in m² on the layout drawing and prepare the location sketch as a separate document, submitting both with the application.
• Budget the floor plan review at USD 240.00 and the technical director registration at USD 48.00 as separate lines.
• Apply for approval under Article 6.2.3 before any relocation or remodelling, and budget both the plan review fee and the relocation fee.
• Enter the expiry date of the technical director practice certificate in the document validity ledger and renew it before it lapses.

5. Verification checklist

• □ Original Director Técnico contract signed
• □ Technical director registration form and payment receipt complete
• □ Original practice certificate from the professional oversight board within validity
• □ Layout drawing showing total area and location sketch prepared
• □ Floor plan approval obtained where manufacturing or conditioning is carried out
• □ Floor plan review fee and technical director registration 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