ISO 13485 Becomes Mandatory in Panama: What Decreto 416 Changed

1. Key takeaways

Yes: an application for a CCT for an imported device must include a currently valid ISO 13485 certificate. The requirement does not come from the original text of Decreto Ejecutivo N° 490. It is the product of Article 2 of Decreto Ejecutivo N.º 416 of 13 May 2020, which rewrote item 10 of Article 36. The original item referred to a certificate of good manufacturing practice or other quality certifications issued by recognised entities. The amended item reads simply Certificado ISO 13485 vigente, a currently valid ISO 13485 certificate. The rewrite places Panama among the small group of Central American jurisdictions that have written ISO 13485 into the general documentary list itself.

Three features of the change matter for planning. First, it is permanent: Decreto Ejecutivo N.º 416 contains no sunset clause for the amendment, even though the considerations behind it were drafted during the COVID period. Second, it narrows the acceptable evidence, so a quality certificate other than ISO 13485 no longer substitutes for it. Third, it operates through the general requirements, which means that every risk class is caught, including class D, where Article 37 still labels the ISO 13485 certificate as optional.

• The mandatory basis is Article 36, item 10, as amended by Article 2 of DE 416.
• The original wording referring to good manufacturing practice certificates has been superseded.
• ISO 13485 now sits in the general list, so all classes A, B, C and D are covered.
• Other quality certifications, including MDSAP and national GMP certificates, do not replace it.
• The exemption in Article 36-A for class A and B devices made by Panamanian public institutions does not include ISO 13485.

2. Legal basis

Decreto Ejecutivo N° 490 of 4 October 2019 contained the original item 10. Decreto Ejecutivo N.º 416, published on 13 May 2020 in Gaceta Oficial 29023-A, replaced Article 36 in its entirety through Article 2, inserted Article 36-A through Article 5, modified Articles 17 and 36, and entered into force on the day following publication under Article 6. The table compares the two texts.

The mechanism of the amendment deserves attention. Article 2 does not delete a word here and insert a word there; it replaces Article 36 as a whole, so every item of the article in force today is the amended text. Any internal note or template that still cites the 2019 version of item 10 is citing a provision that no longer exists in that form.

3. Expert insights

Insight one: the rewrite was COVID-period legislation, but its effect is permanent. The considerations of Decreto Ejecutivo N.º 416 refer to the need to establish special measures in certain procedures before the Ministry of Health so as not to cause a shortage of devices in the country, and the immediate driver was the pandemic. Article 2, however, attaches no time limit to the rewrite of Article 36. It is a permanent amendment. Treating it as a pandemic relaxation, or confusing a pandemic relaxation with a pandemic tightening, leads to a wrong assessment of whether ISO 13485 is mandatory, and that error is expensive because certification takes time.

Insight two: the qualifier vigente is where the file is actually examined. The amended text consists of two elements only, ISO 13485 and vigente. It does not spell out conditions such as the certification scope covering the product applied for, yet in practice the evaluator will check the scope and the expiry date of the certificate (practical estimate). Applicants should therefore ensure three things: that the certificate remains valid throughout the review period, that the certified scope covers the product category applied for, and that the certification body holds the corresponding accreditation.

Insight three: class A and B devices made by Panamanian public institutions are outside the rule. Article 36-A, added by Decreto Ejecutivo N.º 416, sets a separate list of ten requirements for class A and B devices manufactured by public institutions within Panama, and that list contains neither ISO 13485 nor the certificate of free sale. The exclusion confirms the limitation introduced in the amended heading of Article 36, which now speaks of all imported devices. The domestic and the imported documentary chains are separated at that point.

Insight four: the relationship between ISO 13485 and good manufacturing practice needs to be stated precisely. The pre-amendment wording accepted a GMP certificate or other quality certifications issued by internationally recognised entities. The amended wording locks the requirement to ISO 13485. Panama therefore no longer accepts any quality certification from an internationally recognised body as a substitute, and the standard converges on one specific scheme. A manufacturer holding other system certificates, such as MDSAP or national GMP certificates, still has to obtain an ISO 13485 certificate for this purpose.

4. Practical recommendations

• Put ISO 13485 certification on the critical path of the Panama project, because the certification cycle is usually longer than the preparation of the dossier itself.
• Check that the certificate expiry covers the entire review period, including any correction round, and renew before filing where it does not.
• Check that the certified scope covers the product category applied for, and apply for a scope extension where it does not.
• When citing Article 36, item 10, always note that it is the text as amended by DE 416, and avoid quoting the 2019 wording.
• For devices manufactured by Panamanian public institutions, prepare the ten items of Article 36-A for class A and B and do not apply the import list.
• Ask the certification body for a current certificate in a form that shows scope and validity dates clearly, so the evaluator does not have to interpret an annex.

5. Verification checklist

• □ Confirmed that ISO 13485 is mandatory under Article 36, item 10, as amended by DE 416
• □ Certificate validity confirmed to cover the review period
• □ Certified scope confirmed to cover the product category applied for
• □ Accreditation of the certification body verified
• □ Provision cited with the note that it is the text amended by DE 416
• □ Domestic manufacture case confirmed as falling under Article 36-A
• □ No reliance placed on the optional wording in Article 37, item 4(d)

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.