Professional Responsible and Authorised Representative: Nine Duties Under Article 6.2.4.2

1. Key takeaways

Article 6.2.4.2 of RTS 11.03.02:21 assigns 9 duties (a to i) to the professional responsible for medical devices (Profesional responsable de dispositivos médicos): a) handling the sanitary registration of devices intended for marketing, together with its changes, renewal and annual fee; b) handling import authorisations for registered devices; c) ensuring that products sold conform to the registration; d) responding to enquiries from the authority; e) coordinating with the vigilance liaison on vigilance notifications and market withdrawals; f) submitting a resignation to the authority when leaving the appointment; g) reporting any absence exceeding 15 days in writing, naming the substitute and the period, signed and sealed by two professionals and submitted at least 5 days in advance; h) ensuring the quality, safety and efficacy of devices at the applicable regulatory stage; and i) where the role is combined with that of vigilance liaison, meeting the qualifications and functions set by that regulation.

The list is short but unusually dense, because it gathers the entire product lifecycle into a single named individual. Registration, changes, renewal, the annual fee, import authorisation, conformity of what is actually sold, answers to the authority and vigilance coordination all sit with the same person. In practice this makes the professional responsible the natural counterpart to the authority for everything that concerns a product, as distinct from everything that concerns a building.

2. Legal basis

The nine duties, the per-registration binding rule and the fee for changing the appointment are set out in the following provisions.

3. Expert insights

Insight 1: The professional responsible is the product-side role, while the technical director is the establishment-side role. Article 6.2.4.2 a) assigns registration, changes, renewal and the annual fee to the professional responsible, and b) assigns import authorisation to the same person, whereas Article 6.2.4.1 gives the technical director the establishment activities and the inspection interface. The two sets of duties do not overlap and cannot be substituted one for the other. A company must therefore either keep two licensed professionals available or, where one individual holds both posts, be able to demonstrate that both sets of duties are actually performed, because an inspection will test the duties and not the organisational chart.

Insight 2: The professional responsible is bound to each individual registration, so replacement must be handled registration by registration. Article 6.2.1 e) requires the registration holder to appoint a professional responsible and an authorised representative for each registration, and provides that resignation or withdrawal of the appointment must be processed for each sanitary registration with notice to the authority. The arithmetic consequence is direct: replacing one professional responsible across a portfolio of 20 registrations means 20 separate change filings. Section 3.2.2 of the tariff reflects exactly this structure, charging a basic fee of USD 48.00 plus USD 0.60 for each affected registration.

Insight 3: Even a temporary absence requires prior written approval. The final paragraph of Article 6.2.1 e) provides that a temporary absence of the professional responsible requires prior written application to the authority for approval, together with the designation of a substitute supported by the corresponding authorisation documents. Article 6.2.4.2 g) then elaborates the case of absence exceeding 15 days into a written report submitted 5 days in advance and signed and sealed by two professionals. The combined effect is that the professional responsible cannot leave first and report afterwards; the approval must precede the absence, which means cover has to be arranged before travel is booked.

Insight 4: Item c) on conformity, item h) on continuing assurance and item e) on vigilance coordination place the professional responsible at the front line of post-market action. Item c) requires that products sold in the country match the content of the registration under that person’s responsibility, item h) requires quality, safety and efficacy to be assured at the applicable regulatory stage, and item e) requires coordination of vigilance notifications and market withdrawals. Taken together, they mean that when a vigilance event occurs, the authority’s first enquiry lands on the professional responsible rather than on the establishment, and the response will be measured against the registration content the person is accountable for.

4. Practical recommendations

• Where a company holds many registrations, calculate the number of change filings and the total fee before replacing the professional responsible, using USD 48.00 plus USD 0.60 per registration.
• Draw up a comparison table of the professional responsible and technical director duties so that neither role can deflect a task to the other.
• Prepare a written absence report template, file it 5 days in advance and obtain the signatures and seals of two professionals.
• Run a quarterly self-check that registered products match products actually sold, to prevent specification or manufacturer drift.
• Designate the professional responsible as the first contact for vigilance events and set an internal response deadline in advance.
• Maintain the authorised representative (Apoderado) alongside the professional responsible, since changes to either appointment must be filed.

5. Verification checklist

• □ Duty boundaries between professional responsible and technical director tabulated
• □ Number of change filings and total fee calculated before any replacement
• □ Written absence report template prepared
• □ Quarterly conformity self-check between registered and sold products scheduled
• □ First contact for vigilance events designated
• □ Authorised representative registration status maintained in parallel

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