Phased transition periods now expired: the 18/24/30/42-month deadlines under Article 23 of Ley 90

1. Key takeaways

Article 23 of Ley N° 90 sets transitional periods for obtaining a sanitary registration, in four tiers by risk class, for devices that had no technical standard certificate when the law entered into force: 18 months for class D, 24 months for class C, 30 months for class B and 42 months for class A, counted from the entry into force of the law. Counting from 27 December 2017, the date fixed by Article 52 (in force from the day after publication), the four periods came to an end around June 2019, December 2019, June 2020 and June 2021 respectively, and all have now expired. Expiry of a period does not mean the registration channel is open, however: Article 18 of Ley 92 leaves the start date for issuance to the health authority, and the two points must be understood separately.

• The four periods run in inverse order to risk: the highest-risk class gets the shortest period and the lowest-risk class the longest.
• All four periods expired years ago, and none of them opens a channel by itself.
• Article 8 added a six-month pre-registration duty ahead of the transitional periods.
• The moratorium introduced by Ley 92 in September 2019 created a gap between the expiry of the duties and the availability of the route.
• Existing products now fall into three compliance states that must be assessed case by case.
• The registration certificate issued for condoms in 2024 echoes the pre-registration instrument of 2018 in name and function.

2. Legal basis

Article 23 fixes the periods; Article 52 fixes the day from which they run; Article 8 precedes them. Articles 18 of Ley 92 and the CONSIDERANDO of DE 490 explain why the periods expired without a channel opening.

3. Expert insights

Insight 1. The design logic of the phased periods is that higher risk complies first. The four periods correspond inversely to risk class: class D, the highest risk, receives 18 months, the shortest period, while class A, the lowest risk, receives 42 months, the longest. That runs counter to the intuition that low-risk products should be released first, and it reflects a public health ordering of priorities in which high-risk products are brought under supervision first and lower-risk products are covered progressively. Understanding the logic helps in anticipating the sequence DNDM is likely to follow if and when it activates the registration channel.

Insight 2. An institutional gap opened between the expiry of the periods and the availability of the channel. The periods in Article 23 ran from the end of 2017, and the last of them, 42 months for class A, expired in mid-2021. Ley 92 had meanwhile established the moratorium in September 2019 and handed the decision to begin issuing registrations to the health authority. The result is that the duties fell due first and the channel became available later, if at all. That gap is the origin of the present confusion over which credential applies, and it is also why secondary sources contradict one another: each describes a different part of the sequence as though it were the whole.

Insight 3. The six-month pre-registration in Article 8 was the outpost of the transitional period. That article required DNDM to establish a database and a procedure allowing products already being sold in the country without a CCT at the entry into force of the law to be pre-registered, within six months, with a registration certificate (certificado de inscripción) available for printing. It is worth noting that Article Octavo of Resolución N° 003 in 2024 issues precisely a Certificado de Inscripción for condoms. The echo in naming suggests that Panama is reusing the registration layer of the earlier mechanism to rebuild market access, one category at a time.

Insight 4. Once the transitional periods have expired, the compliance status of existing products has to be verified case by case. Because of the moratorium, it cannot simply be assumed that expiry of a period means a registration must now be held. In practice three states should be distinguished: products holding an old CCT converted into a registration under Article 22 of Ley 90; products that completed pre-registration and were then handled under the requirements in force at the relevant time; and products newly entering the market. The obligations attached to each state differ, and no single conclusion can cover all three. That is a practical estimate of how the file has to be read, not a proposition stated in any one article.

4. Practical recommendations

• Do not treat the expiry of the transitional periods as a conclusion that a registration must be held; verify the channel status separately under Article 18 of Ley 92.
• Inventory existing product lines by the three states, and confirm the obligations that apply to each one at the present time.
• Schedule new market entrants against the credential that can be obtained today, whether a CCT or a category registration.
• Anticipate that DNDM may follow a high-risk-first order when it activates the channel, and prepare files for class D products in advance.
• Maintain a legal-source watch so that a conversion assessment can begin immediately once a start date is published.

5. Verification checklist

• □ Record the four periods in Article 23: D 18, C 24, B 30 and A 42 months
• □ Confirm the starting point as the entry into force of Ley 90 (Article 52: the day after publication)
• □ Confirm that all four periods have expired
• □ Keep expiry of the periods distinct from the opening of the channel (Article 18 of Ley 92)
• □ Inventory existing products across the three compliance states
• □ Prepare a conversion plan for the announcement of a start date

Related reading: [The transitional status of legacy CCTs under DE 468 of 2007: Article 22 of Ley 90](/panama-medical-device-registration/decreto-468-legacy-cct-transition/) | [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/) | [When more clinical evidence is needed: the six situations in Article 42 of DE 490](/panama-medical-device-registration/when-more-clinical-evidence-needed-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