Instructions for Use: The 17 Items Required by DE 490 Article 38

Updated: 2026-11-11 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

Article 38 of Decreto Ejecutivo N° 490 requires that a device be accompanied by instructions for use and/or a package insert (instructivo y/o inserto) giving the user information on safety, performance and identification, and it lists seventeen items that the document must contain, each qualified by the phrase cuando aplique, where applicable. The seventeen items run from intended purpose and declared performance through to radiation protection, reprocessing of reusable devices and restrictions on combination with other devices. It is the longest single list in the Panamanian documentation set, and the one where a product-specific reading matters most, because a large part of it only bites for particular device types.

The list is drafted to mirror the information a user needs in order to handle the device safely rather than to mirror a manufacturing file. Items 10, 16 and 17 carry lettered sub-items, and those sub-items are where most omissions occur: installation and maintenance, radiation emitted for medical purposes, and warnings and limitations respectively.

Seventeen content items, each applicable where relevant to the device.
Residual risk, contraindications and expected side effects belong in the instructions under item 5.
Item 10 covers installation and maintenance in four lettered sub-items.
Item 16 addresses radiation at the level of nature, type, and where applicable intensity and distribution.
Item 17 gathers six categories of warnings and restrictions.

2. Legal basis

The requirement is Article 38 of Decreto Ejecutivo N° 490 of 4 October 2019. Items 1 to 17 are set out below in the order of the article, followed by the final paragraph on language.

Document	Provision	Content of the seventeen items
Decreto Ejecutivo N° 490 (4 October 2019)	Article 38, item 1	The generic or trade name of the device
Same	Article 38, item 2	Name and address of the manufacturer
Same	Article 38, item 3	Information on use or the intended purpose of the device
Same	Article 38, item 4	Intended performance as declared by the manufacturer
Same	Article 38, item 5	Residual risks, contraindications and expected side effects, including information that must be given to the patient
Same	Article 38, item 6	Specifications needed for correct use, such as declared accuracy where the device has a measuring function
Same	Article 38, item 7	Where the device contains or incorporates a medicinal substance and/or material of biological origin, identification of that substance or material
Same	Article 38, item 8	Details of preparation or handling required before use, such as sterilisation, assembly or calibration
Same	Article 38, item 9	Requirements as to facilities, special training or particular qualifications of the user or third parties
Same	Article 38, item 10	Information needed to verify that the device is correctly installed and can operate safely as intended, including (a) nature and frequency of periodic and preventive maintenance together with cleaning and disinfection; (b) identification and replacement of consumable components; (c) calibration information needed to ensure safe operation throughout the life cycle; (d) methods to eliminate risks encountered by installation, calibration or repair personnel
Same	Article 38, item 11	Special storage or handling instructions where applicable
Same	Article 38, item 12	Instructions for use where a sterile device is damaged before use of its sterile packaging
Same	Article 38, item 13	Appropriate sterilisation instructions for devices supplied non-sterile and intended to be sterilised before use
Same	Article 38, item 14	Information on appropriate processing of reusable devices, including cleaning, disinfection, packaging and re-sterilisation methods where applicable
Same	Article 38, item 15	Where the device is intended for use with other devices and/or general equipment: (a) information identifying those devices or equipment so that a safe combination is obtained; (b) known restrictions on combinations of devices and equipment
Same	Article 38, item 16	Where the device emits hazardous or potentially hazardous radiation for a medical purpose: (a) detailed information on the nature, type and, where applicable, intensity and distribution of the radiation emitted; (b) methods of protecting the patient, user or third parties from unintended radiation
Same	Article 38, item 17	Information enabling the user and/or patient to understand alarms, precautions, measures to be taken and restrictions on use relating to the device, including (a) warnings, precautions and measures where a fault or change in performance affects safety; (b) warnings on exposure to reasonably foreseeable external influences or environmental conditions; (c) warnings where the device presents a risk of interference during specific diagnostic, evaluation or treatment use; (d) restrictions and incompatibilities where the device administers a medicinal product; (e) warnings and restrictions concerning medicinal substances or biological materials incorporated as a component of the device; (f) precautions concerning carcinogenic, mutagenic or toxic materials contained in the device, or materials likely to cause sensitisation or allergic reaction
Same	Article 38, final paragraph	Instructions or the package insert may be printed in two or more languages provided that one of them is Spanish; exemptions are determined by the DNDM according to risk class and device type

3. Expert insights

Insight one: item 5 writes residual risk into the instructions, which closes the risk management loop. The text refers to Riesgos residuales, contraindicaciones y efectos secundarios previstos, incluyendo información que se deba decir al paciente. Putting residual risk into the instructions means the manufacturer must already have completed the risk analysis and converted the remaining risk into information for the user. This closes the loop with Article 37, item 4(a), which requires class D applicants to submit a risk analysis: the analysis at the filing end lands in the instructions at the user end.

Insight two: the four sub-items of item 10 bring installation and maintenance into the instructions, which matters most for equipment. Sub-item (a) requires the nature and frequency of maintenance, (b) requires identification of consumable components, (c) requires calibration information, and (d) requires methods to eliminate the risks faced by installation and repair personnel. These four are frequently missing from generic instructions, yet for equipment they cover precisely the stages where incidents cluster.

Insight three: the radiation requirement in item 16 goes down to intensity and distribution. The item requires not only the nature and type of radiation but, where applicable, detailed information on intensity and distribution, together with protection methods. For imaging and therapeutic equipment that emits radiation, this effectively calls for technical parameter-level material rather than a statement that the device contains ionising radiation.

Insight four: the six sub-items of item 17 concentrate on warnings and restrictions and account for much of the length of the document. From fault handling and environmental influences through electromagnetic interference, administration limits and incorporated substances to carcinogenic and sensitising materials, the six categories form the core of the second half of the instructions. In practice this is the part most likely to drift away from the version used in the country of origin, because a home-market instruction leaflet does not necessarily cover every sub-item Panama requires.

4. Practical recommendations

Build a seventeen-line checklist for the instructions, marking each line applicable or not applicable and recording the reason for each exclusion.
Do not simply reuse the country of origin leaflet; add the localisation items required by Article 38, especially items 16 and 17.
Give the four sub-items of item 10 their own section covering maintenance, consumables, calibration and personnel protection.
Print in several languages with Spanish included, and keep a list of the language versions issued.
Keep the intended purpose consistent across the instructions, the label and the application dossier.

5. Verification checklist

□ All seventeen items of Article 38 checked, with reasons recorded for each exclusion
□ Residual risks, contraindications and side effects present under item 5
□ Four sub-items of item 10 present: maintenance, consumables, calibration, protection
□ Radiation information under item 16 covers nature, type, intensity and distribution
□ Six warning sub-items under item 17 present
□ At least one language version is Spanish, per the final paragraph of Article 38

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.

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

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