Regulation Cycle in Three Phases under Article 5.1

1. Key takeaways

Article 5.1.1 of RTS 11.03.02:21 divides the device regulatory cycle into three phases. Pre-commercialisation covers product development, risk assessment, clinical research and manufacturing, including establishment authorisation. Commercialisation covers sanitary registration authorisation, import control, market quality control, BPM compliance verification, and storage and distribution. Post-commercialisation is technovigilance, covering the investigation of events and incidents, sanitary inspection and product quality control. Article 5.1.3 requires the authority to ensure the quality, safety and efficacy of devices at any stage of the cycle.

The three phases are best understood as one continuous obligation rather than three sequential approvals. A registration certificate marks entry into the second phase, not the end of supervision, and the evidence assembled in the first phase remains available for examination in the third.

• Pre-commercialisation includes development, risk assessment, clinical research, manufacturing and establishment authorisation.
• Commercialisation adds import control, market quality control, BPM verification, storage and distribution.
• Post-commercialisation is technovigilance, with incident investigation and inspection.
• Article 5.1.2 subjects every authorised device to vigilance under the regulation.
• Article 5.1.3 gives the authority a mandate across the whole cycle.

2. Legal basis

The cycle is defined in Article 3.10 and structured in Article 5.1.1, with the vigilance limb linked onward to the dedicated regulation by Article 6.5.3. The table records the provisions that a phase-by-phase register has to reflect.

3. Expert insights

Insight one: the three phases form a continuous system, not three separate approvals. The opening words of Article 5.1.1 describe the phases as articulated within a continuous system of inspection, vigilance and control operated by the authority. The practical result is that an establishment authorisation obtained in the first phase can be inspected without prior notice in the third, under Article 6.5.1 d), and a batch release certificate submitted in the second phase can be called for during post-market sampling under Articles 6.4.1 f) and 6.5.2. Being already approved is not an answer to a later enquiry.

Insight two: the obligations of the commercialisation phase are broader than the registration itself. Article 5.1.1 b) places import control, market quality control, BPM compliance verification, storage and distribution inside the commercialisation phase. Holding a registration number therefore only brings a product into that phase. The holder must also maintain the annual fee for the importer establishment under Article 6.4.1 b), keep batch release certificates available under Article 6.4.1 f), and accept unannounced inspection under Article 6.5.1 d). Each of these sits outside the registration file and is often owned by a different team.

Insight three: the words any stage give the authority a power to reach back through the file. Article 5.1.3 requires the authority to ensure quality, safety and efficacy at any stage of the cycle, and Article 5.4.2 adds that the authority may request supplementary information or clarification at any stage. The consequence is that a vigilance event after launch can prompt a review of technical documents submitted before launch. Technical tables and risk reports in the file must therefore remain consistent over time, because a revision made in year four can be read against a claim made in year one.

Insight four: the vigilance phase is now governed by a dedicated regulation. Article 5.1.1 c) labels the post-commercialisation phase as Tecnovigilancia, and Article 6.5.3 refers the obligations as a whole to the RTS in that field upon its entry into force. That reference is now satisfied by RTS 11.03.04:23, published on 2024-04-12. The transitional wording has served its purpose, and vigilance obligations can be planned against a stand-alone technical regulation rather than inferred from the main rule.

Insight five: the phase structure also sets the order in which applications are filed. Establishment authorisation is placed in the pre-commercialisation phase, while sanitary registration and import control sit in the commercialisation phase. That allocation is not cosmetic: it indicates that the premises question is settled before the product question, and that import control follows registration rather than running alongside it. A project plan that files the registration first and then discovers that the importer has no establishment authorisation is working against the structure of Article 5.1.1, and the delay usually appears at the point of first shipment rather than at the point of submission.

Insight six: Article 5.1.2 leaves no device outside vigilance. The provision subjects all authorised devices to vigilance under the regulation and is stated without qualification as to class or volume. A product with a single unit in the country is therefore covered on the same terms as a high-volume line, and the process has to exist from the moment of first placement rather than being assembled after an incident. That is the reason the vigilance referent requirement sits in Article 6.2.1 b) at establishment level: the obligation is continuous, while a response written after the event is not.

4. Practical recommendations

• Maintain a separate register for each phase: pre-commercialisation for establishment authorisation, clinical work and risk assessment; commercialisation for registration, import, annual fees and batch release; post-commercialisation for vigilance, inspection and quality control.
• Archive the technical documents submitted before launch so they can be retrieved during a later review, keeping version numbers aligned with the technical tables.
• During the commercialisation phase, look beyond the registration number and keep the annual fee and registration status of the importer establishment up to date.
• Prepare a response routine for unannounced inspection: the Director Técnico present, and stock and distribution records retrievable on the spot.
• Build vigilance processes on RTS 11.03.04:23 rather than carrying over transitional arrangements.
• Write the authority’s right to request supplementary information at any stage into the responsibility clauses of contracts, with an agreed response deadline.

5. Verification checklist

• □ Registers exist separately for the three phases
• □ Pre-launch technical documents are archived with version labels
• □ The annual fee and registration status of the importer establishment are maintained
• □ A response routine for unannounced inspection is in place
• □ Vigilance processes have been switched to RTS 11.03.04:23
• □ Response deadlines for supplementary information are written into contracts

Instruments cited: RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), Articles 3.10, 5.1.1, 5.1.2, 5.1.3, 5.4.2, 6.4.1 b) and f), 6.5.1 d) and 6.5.3.

Regulatory information verified as at 29 October 2026.

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