Technical Director: Thirteen Duties Under Article 6.2.4.1

1. Key takeaways

Article 6.2.4.1 of RTS 11.03.02:21 assigns 13 duties (a to m) to the technical director of medical devices (Director Técnico de dispositivos médicos). Two of them carry explicit deadlines. Item i) requires resignation from the post to be reported to the authority and to the establishment owner 1 month in advance. Item j) requires any absence exceeding 15 days to be reported in writing, naming the substitute professional and the period of absence, with the document signed and sealed by two professionals and submitted at least 5 days before the absence begins. Item k) covers the handover of physical inventory to the owner and the authority when the contract ends, item l) covers coordination with the vigilance liaison on vigilance notifications and market withdrawals, and item m) requires the technical director who also acts as vigilance liaison to meet the qualifications and functions set by that regulation.

The structural feature of the article is that it mixes continuous obligations with event-driven ones. Most of items a) to h) describe a standing state of supervision that must exist every day, while items i) to m) are triggered by a resignation, an absence, a contract ending or an inspection. A compliance system built only around events will satisfy the second group and fail the first, which is where inspections usually begin.

2. Legal basis

The duties, the two deadlines and the vigilance interface are set out in the following provisions.

3. Expert insights

Insight 1: Five of the 13 duties operate as hard prohibitions on sale, and item c) is the most demanding of them. Article 6.2.4.1 c) lists seven situations in which a device may not be distributed: no sanitary registration, expired, deteriorated, counterfeit, subject to a sanitary alert, held as a retained sample, or sealed by the authority. It adds that medical samples, donations and the property of any public institution may not be sold. This is the duty that carries the heaviest personal exposure for the technical director, because each of the seven situations leaves physical evidence that an inspector can find on a shelf, in a warehouse management system or in an invoice trail.

Insight 2: The two deadlines, 1 month and 5 days, are mandatory and both require a written instrument. The resignation report under item i) must go to the authority and to the establishment owner at the same time, which means the owner cannot be informed informally first. The absence report under item j) must be signed and sealed by two professionals and lodged at least 5 days before the absence begins. Where either step is skipped, the establishment sits without a responsible person for the duration, which directly affects the active status required under Article 6.2.2. A gap in coverage is therefore not an HR matter but a licensing defect.

Insight 3: The technical director is the point of contact for inspections and the person who signs the inspection record. Article 6.2.4.1 h) requires the technical director to cooperate with the sanitary inspection carried out by the authority and to provide facilities and information. Articles 6.5.1 e) and f) go further and provide that the technical director must secure that cooperation and must sign the inspection record (acta) in duplicate once the inspection is complete. Where signature is refused, the inspector signs alone and records that circumstance, and that note stays in the file. Declining to sign does not neutralise the record; it adds a second, more damaging fact to it.

Insight 4: The technical director may also serve as vigilance liaison, but only by meeting both sets of qualifications. Article 6.2.4.1 m) provides that where the technical director also acts as Referente de Tecnovigilancia, the qualifications and functions set by the technical regulation in that field must be met. RTS 11.03.04:23 was published on 2024-04-12, so this combined appointment is no longer a soft requirement awaiting entry into force. Where a small enterprise combines the two roles to save cost, it must confirm that the individual’s competence actually covers both functions and not merely the establishment-side duties.

4. Practical recommendations

• Break the 13 duties into a job description that assigns an execution frequency and a record-keeping method to each item.
• State in the technical director contract that resignation requires 1 month written notice to the authority and the owner, and make that obligation a contractual responsibility.
• Prepare an absence report template covering the substitute name, the absence period and the signatures and seals of two professionals, and file it 5 days in advance.
• Configure inventory blocking rules against the seven prohibited situations in Article 6.2.4.1 c), so that retained samples and donations cannot enter the sales flow.
• Designate the technical director as the sole contact for inspections and retain a copy of every signed inspection record.
• Where the roles are combined, confirm that the individual’s qualifications cover the requirements of RTS 11.03.04:23.

5. Verification checklist

• □ All 13 duties translated into the job description
• □ One-month resignation notice obligation written into the contract
• □ Absence report template ready, including two signatures and seals
• □ Inventory system configured with the seven blocking rules
• □ Inspection contact and record retention process designated
• □ Qualifications for the combined vigilance liaison role confirmed

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