Biomedical Equipment: The Four Special Requirements of Article 41

1. Key takeaways

Article 41 of Decreto Ejecutivo N° 490 sets four additional requirements for suppliers selling biomedical equipment (equipo biomédico). First, manuals that supplement the manufacturer technical literature, covering operation, function and/or maintenance, may be filed, and the data sheet, product data and technical service manuals may be in Spanish or in English. Second, a certificate from the manufacturer confirming that the local distributor has suitably trained technical support staff able to provide installation, operation, maintenance and calibration throughout the life cycle of the equipment, and to supply spare parts and tools; where that capability does not exist, a manufacturer commitment to train the staff of the company and to supply spare parts and tools is required instead. Third, the manufacturer instructions and data on storage and transport of the equipment, where applicable. Fourth, a list of accessories, spare parts and consumables described by the manufacturer, any change to which must be notified to the DNDM within 30 calendar days of notification by the manufacturer, failing which the CCT is suspended.

The four items shift the centre of gravity of the file. For consumables the question is whether the documentary set is complete; for biomedical equipment the question is also whether the supplier can keep the device within the manufacturer specifications once it is in service in Panama.

• Four additional items under Article 41, on top of the general requirements.
• Data sheet, product data and technical service manuals may be in Spanish or English.
• Local technical service capability, or a manufacturer training and supply commitment, is a condition of the file.
• Storage and transport instructions are required where applicable.
• Changes to the accessory, spare part and consumable list must reach the DNDM within 30 calendar days of the manufacturer notification.

2. Legal basis

Article 41 of Decreto Ejecutivo N° 490 of 4 October 2019 contains the four requirements. Definition 47 of Article 2 determines what counts as biomedical equipment, and Article 27 and items 8, 12 and 13 of Article 36 complete the picture by removing certain obligations that would otherwise apply.

Read together, these provisions create a separate channel. Definition 47 removes implants and single-use devices from the category, Article 27 removes the possibility of a family application, and Article 41 adds four obligations that have no counterpart in the consumables list.

3. Expert insights

Insight one: item 2 turns local technical service capability into a condition of entry, and that is the most substantive threshold for equipment. The item requires a manufacturer certificate confirming that the local distributor has trained technical staff able to provide installation, operation, maintenance and calibration throughout the life cycle, and to supply spare parts and tools. In effect the supplier must demonstrate continuing service capability in Panama, not merely selling capability. For manufacturers without a local service network, the second sentence of item 2 provides the alternative: a manufacturer letter of commitment covering training and supply.

Insight two: the 30 calendar days in item 4 is a hard deadline with a stated consequence. The text provides that any modification to the list must be notified to the Directorate within the first thirty calendar days following notification by the manufacturer, and that failure to comply will lead to suspension of the Certificate of Technical Criteria. Two points deserve attention. The period runs in calendar days rather than working days, and it starts from the manufacturer notification rather than from the moment the supplier learns of the change. A company therefore needs a notification channel agreed with the manufacturer in advance, or it will breach the deadline without any fault of its own.

Insight three: biomedical equipment benefits from three exclusions and one relaxation in the documentary list. Items 8, 12 and 13 of Article 36 disapply the Spanish instructions, the colour photographs of the product and the colour label copy respectively, while Article 41, item 1 relaxes the language rule so that the data sheet may be in English. Taken together, these four adjustments mean that the documentary structure of an equipment file differs substantially from that of a consumables file. Preparing equipment against the consumables list means filing a volume of inapplicable material; preparing consumables against the equipment list means omitting the label and the instructions.

Insight four: Article 41, Article 27 and definition 47 together form an independent channel for equipment. Definition 47 excludes implantable devices and single-use devices, Article 27 excludes family applications, and Article 41 adds four separate requirements. The institutional meaning of the three together is that biomedical equipment is managed unit by unit rather than group by group, and that service capability is the central point of assessment. That stands in contrast with consumables, which are handled one certificate per group with specifications at the centre.

4. Practical recommendations

• When selecting a local distributor for an equipment project, treat technical service capability, in staff, spare parts and tools, as a core evaluation criterion rather than a secondary one.
• Where local service capability is absent, obtain the manufacturer training and supply commitment in advance under the second sentence of Article 41, item 2.
• Agree an immediate notification obligation with the manufacturer for changes to the accessory, spare part and consumable list, so that the 30 calendar day notification to the DNDM can be met.
• Prepare the file against the equipment list and do not apply the three general requirements that are disapplied for equipment.
• Keep a version log of the accessory list, recording for each change the date of the manufacturer notification and the date of the notification to the DNDM.
• Confirm at the outset that the product falls within definition 47, since an implantable or single-use device that receives no preventive or corrective maintenance is outside the category.

5. Verification checklist

• □ Product confirmed as biomedical equipment under definition 47, excluding implants and single-use devices
• □ Operation, function and maintenance manuals submitted under Article 41, item 1
• □ Manufacturer certificate of technical support capability, or training commitment, obtained under item 2
• □ Storage and transport instructions submitted under item 3
• □ Accessory, spare part and consumable list submitted under item 4
• □ Mechanism in place to notify list changes to the DNDM within 30 calendar days

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

Regulatory information verified as of 29 October 2026.