Essential Principles Under Article 6

1. Key takeaways

Article 6 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, first states the general rule: the corresponding sanitary authorisation must be obtained before engaging in the manufacture, upgrading, repackaging, import, export, storage, transport, distribution, sale, lending and/or maintenance of devices. It then sets 5 WHO essential principles of quality, safety and effectiveness that manufacture must strictly follow: 1 design and production processes must ensure that the device is safe when used as intended by users with the necessary technical knowledge and training, without compromising the clinical condition of patients or the health of users; 2 the manufacturer must assess foreseeable and known risks and reduce them at the design, production and use stages; 3 the device must perform as intended by the manufacturer under appropriate conditions; 4 quality, safety and effectiveness must not be compromised within the service life of the device, nor damaged during transport, packaging and storage according to the manufacturer instructions; 5 the manufacturer is responsible for ensuring that the device meets the essential principles of safety and performance, and ARSA may verify conformity before or after placing on the market through technical document review, sanitary inspection or other necessary assessments.

• The burden of proof rests on the manufacturer, and verification covers the post-market phase, so technical documents must remain available on demand rather than being archived after filing.
• The five principles map onto three concrete reports in the Clase I dossier: the safety report, the corrective action report on vigilance events, and the risk management report.
• The authorisation duty covers all 11 listed activities, while the five principles attach to manufacture only.

2. Legal basis

The provisions on the essential principles and their evidentiary counterparts are the following.

3. Expert insights

Insight 1: Article 6 and Article 43 map one to one. The five principles of Article 6 correspond in the Clase I dossier of Article 43 to three concrete documents: item 6, the safety report (which must list existing sanitary alerts), item 7, the report of corrective actions on alert events verified by the product holder (where applicable), and item 8, the risk management report. In other words, the principles are the review standard and the dossier is the evidence: the three reports are not formalities but the written implementation of principles 1, 2 and 4.

Insight 2: item 4 writes transport and storage into the principles. The provision expressly requires that quality, safety and effectiveness not be damaged during transport, packaging and storage according to the manufacturer instructions. This directly supports the transport licence regime of Article 18, under which biomedical equipment, IVD and other devices of sanitary interest that need special transport conditions apply separately for a transport licence. For cold-chain product planning, transport validation records must trace back to the manufacturer instructions.

Insight 3: the verification moment of item 5 covers the post-market phase. The provision allows ARSA to verify conformity before or after the device is placed on the market, through technical document review, sanitary inspection or other necessary assessments. This closes the loop with the quality control sampling of Articles 80 to 82, the analytical and retained samples of Article 81, and the allocation of costs in Article 82. The practical meaning is that technical documents must remain retrievable on demand and must cover batches already on the market.

Insight 4: the risk assessment of item 2 is not a one-off exercise. The provision requires the manufacturer to assess foreseeable and known risks and to reduce them across design, production and use. Article 48 in turn treats a significant change in specifications or chemical composition as a trigger for reclassification by ARSA. Taken together, this means that risk management documents must be updated in step with design changes, otherwise the filing will be found evidentially insufficient at modification review or reclassification.

Insight 5: the principles apply to manufacture, but the authorisation duty covers all 11 activities. The opening paragraph of Article 6 covers manufacture, upgrading, repackaging, import, export, storage, transport, distribution, sale, lending and maintenance, while the five principles attach to manufacture only. This distinction matters: importers and distributors bear no design-level principle duties under Article 6, but they do bear the establishment duties of Article 11 and the authorisation duty of Article 33.

4. Practical recommendations

• Convert the five principles of Article 6 into a cross-reference table mapped item by item to the three reports of Article 43 and other dossier documents.
• Prepare transport validation records early for cold-chain and special-transport products, traceable to the manufacturer instructions.
• Keep a version register of technical documents so the current version can be retrieved on demand during post-market sampling.
• Update risk management documents in step with design changes and assess whether Article 48 reclassification is triggered.
• Separate the duty boundaries of manufacturers and importers: principle duties lie with the manufacturer, authorisation and establishment duties with the importer.
• Add the five principles of Article 6 to the supplier audit checklist as a compliance gate for choosing manufacturers.

5. Verification checklist

• □ A cross-reference table between the five principles of Article 6 and dossier documents exists
• □ Cold-chain products have transport validation records traceable to the manufacturer instructions
• □ Technical documents have a version register retrievable at any time after market placement
• □ The design change process includes the synchronised update of risk management documents
• □ The duty boundaries of manufacturers and importers are distinguished in internal SOPs
• □ The supplier audit checklist includes the five principles of Article 6

Regulatory information verified as of 2026-10-29.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Honduran market. Our team manages Secretariat of Health (SESAL) registration applications through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com