Sanitary Inspections Under Article 6.5.1 of El Salvador’s Device Regulation

1. Key takeaways

Article 6.5.1 of RTS 11.03.02:21 governs sanitary inspections through ten items, lettered (a) to (j). Two of them carry the greatest practical weight. Item (d) covers inspections carried out on vigilance grounds: the owner or personnel of the premises receive no prior notice, and such an inspection may be conducted at any point in the regulatory life cycle of the device. Item (i) provides that samples are sent to the competent authority’s quality control laboratory for analysis, and that the costs relating to product quality testing are borne by the owner of the inspected premises. Items (f) and (g) require an acta to be drawn up at the close of the inspection in two identical copies, recording the place, the date and time, the findings, the recommendations and the period allowed for correction.

• Two inspection routes exist side by side, and their notification rules are opposites: one is requested by the regulated party and scheduled in order of receipt, the other is triggered by vigilance and arrives unannounced.
• The party bearing sampling costs under item (i) is the owner of the premises, which is not the same entity as the device holder referred to in Article 6.5.2 (b).
• Sealing, withdrawal from circulation and confiscation under item (h) are the heaviest consequences an inspection can produce, and they can be triggered by suspicion of anomaly rather than by confirmed defect.
• The acta is issued in duplicate, a copy is handed to the technical director or the premises representative, and a refusal to accept or sign it is recorded rather than allowed to invalidate the document.
• The Tarifario prices storage, distribution and transport audits at USD 240.00, with certification of each transport vehicle at USD 24.00.

2. Legal basis

The inspection powers sit in the technical regulation on medical devices, with the fee schedule supplying the chargeable events. The table below sets out the provisions relied on in this note, together with the identification of each instrument.

3. Expert insights

The first point to absorb is that the two inspection routes operate on opposite notification rules. Article 6.5.1 (c) applies to inspections requested by the regulated party, such as the acceptance inspection of a new premises before operations begin: the visit is scheduled in order of receipt, a written request must be filed, and the fee must be evidenced by a receipt number. Article 6.5.1 (d) applies to inspections arising from vigilance, and there is no prior notice at all. A company cannot use its experience of the first route to predict the second. The second route can materialise on any working day, at any premises that already holds an authorisation.

The second point concerns who pays. Article 6.5.1 (i) allocates the cost of samples taken on site and sent for analysis to the owner of the inspected premises. Article 6.5.2 (b) allocates the cost of quality control testing to the device holder, the titular. These are two separate charges resting on two separate legal persons. In a multi-brand distribution business the two charges will frequently land on different entities within the same group, and budgeting them as a single line hides that split.

The third point is that item (h) produces the most severe outcome available at an inspection. The provision lists expired, deteriorated, altered, unregistered and apparently anomalous devices as its objects, and the measures are inventory, sealing, keeping the goods out of circulation, and confiscation of product where necessary. The wording is presunción de anomalías, a suspicion of anomaly. No confirmed defect is required for a suspicion to be raised, and that is a substantive requirement bearing directly on stock control rather than a formality.

The fourth point is procedural and works in the company’s favour. Items (f) and (g) require the acta in two copies, recording findings and the correction period, with a copy delivered to the technical director or the premises representative. If the other side refuses to accept it, that refusal is entered in the record under item (g). If a signature is withheld, the inspector signs alone and notes the circumstance under item (f). A refusal to sign therefore does not void the record. The workable response is to acknowledge receipt and then use item (j) to submit an improvement plan within the period granted.

4. Practical recommendations

• Separate the two inspection routes in the internal manual: the requested route, which is scheduled and paid for, and the vigilance route, which arrives without notice and therefore requires standing readiness.
• Designate the technical director as the single point of contact for inspections, and name an authorised alternate in advance for periods of absence.
• Configure the warehouse with a segregated area covering the five categories in item (h): expired, deteriorated, altered, unregistered and suspected anomaly.
• Acknowledge the acta on receipt and then submit the improvement plan under item (j); refusing to sign achieves nothing and is recorded against the company.
• Budget the two charges separately: inspection sampling costs, borne by the premises owner, and quality control testing costs, borne by the device holder.
• Archive the acta and the improvement plan together, since they serve as compliance evidence for later changes and for renewal.

5. Verification checklist

• □ The two inspection routes are distinguished in the internal manual
• □ The technical director and an alternate have been designated as inspection contacts
• □ A segregated stock area has been set up for the five categories
• □ A process exists for acknowledging the acta and filing the improvement plan
• □ The two cost bearers are separated and both are budgeted
• □ Actas and improvement plans are archived

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