Legacy CCTs under DE 468 of 2007: transitional status under Article 22 of Ley 90

1. Key takeaways

Technical standard certificates still valid at the time Ley N° 90 was enacted, issued under Decreto Ejecutivo 468 de 7 de noviembre de 2007, are deemed valid sanitary registrations and technical standard certificates, and retain the validity period stated in that CCT; whereas CCTs issued after Ley 90 entered into force may not be used as a sanitary registration. The basis is Article 22 of Ley N° 90. This is a conversion clause for credentials already in existence, and its value lies in the fact that, in the years when the registration channel was not open, certificates issued under the 2007 system were given registration status directly.

• The clause operates as a time slice: what decides is the date of issue, not the product, the risk class or the manufacturer.
• Certificates converted under this article retain the validity stated on their face, and the period is not restarted.
• CCTs issued after 27 December 2017 cannot be asserted as a sanitary registration.
• Article 22 sits alongside Articles 8 and 23 to make a three-branch treatment of products already on the market.
• This provision is the origin of much of the confusion about how long a Panamanian device registration lasts.
• In contracts and due diligence the word registration should always be qualified by how it was obtained.

2. Legal basis

Article 22 depends on dates fixed elsewhere: the date the statute entered into force under Article 52, and the transitional duties in Articles 8 and 23. DE 490 then sets the validity of the certificates issued today.

3. Expert insights

Insight 1. Article 22 is a time-slice clause, and its application depends entirely on when the certificate was issued. The provision establishes two sides of a single date: certificates issued before the enactment of Ley 90 (26 and 27 December 2017) and still valid at that moment acquire registration status, while certificates issued afterwards do not. The criterion is mechanical — it looks at nothing but the issue date. A company reviewing its historical credentials should therefore begin with that date and its relationship to the entry into force of the law, rather than with the product family or the commercial history of the device.

Insight 2. Retaining the validity stated in the original certificate means this cohort has probably expired in full. Article 22 provides that the converted certificates “mantendrán el período de vigencia establecido en el Certificado de Criterio Técnico” — they retain the validity period stated in the technical standard certificate, not a period restarting from conversion. Given that the law took effect in 2017 and that DE 490 gives the CCT in force today a validity of five years, the converted certificates have in all likelihood reached the end of their term by now. That is a practical estimate rather than a documented fact in any single instrument, and the historical significance of the clause is greater than its present-day significance.

Insight 3. Articles 22, 8 and 23 together create a three-branch treatment of existing products. At the entry into force of Ley 90, products already on the market fell into three groups: those holding a valid old CCT (Article 22, deemed registration), those without a CCT (Article 8, pre-registration within six months, and Article 23, registration within 18 to 42 months according to risk class), and new entrants to the market, which follow the ordinary route. Three provisions divided the legacy problem cleanly in a single legislative step, which is a comparatively complete piece of drafting by Central American standards and explains why the transitional framework is still being applied today.

Insight 4. This provision explains why the registration validity period cannot be stated cleanly in Panama. The registration status of legacy certificates comes from conversion rather than from fresh issuance, so its duration follows what the original CCT recorded, while the validity of newly issued registrations has not been laid down by DE 490 at all. Two sources and two methods of calculation are the origin of the competing five-year and ten-year figures in industry material. The accurate formulation is that DE 490 makes no provision for the validity of a device sanitary registration, with converted legacy certificates as the exception.

4. Practical recommendations

• When reviewing historical credentials, first check whether the issue date precedes the entry into force of Ley 90 (27 December 2017).
• Manage converted certificates according to the validity recorded on the original, and do not assume a fresh five-year term.
• CCTs obtained after 27 December 2017 cannot be asserted as a registration and must be handled under the requirements in force at the time.
• For existing products without a CCT, confirm whether the six-month pre-registration was completed in its year; where it was not, treat the product as a new entrant.
• In contracts and due diligence, state the origin of any registration referred to, whether obtained by conversion or by fresh issuance.

5. Verification checklist

• □ Check the certificate issue date against the entry into force of Ley 90 (27 December 2017)
• □ Confirm whether the certificate was issued under DE 468 de 2007
• □ Confirm validity from the original certificate, and do not assume five years
• □ For existing products, confirm whether the six-month pre-registration under Article 8 was completed
• □ Check under Article 23 whether the transitional period for the relevant class has expired
• □ State the origin of the registration in contracts and due diligence material

Related reading: [Five cases of registration-exempt import: Article 21 of Ley 90, including 90 days for trade fairs](/panama-medical-device-registration/registration-exempt-import-panama/) | [The no-prior-testing principle: Article 15 of Ley 90 and its exceptions](/panama-medical-device-registration/no-prior-analysis-rule-panama/) | [The four special requirements for biomedical equipment (Article 41 of DE 490)](/panama-medical-device-registration/biomedical-equipment-requirements-panama/)

Regulatory information verified as of October 29, 2026.

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