Article 18 of Ley 92 and the registration start date: how the moratorium works

1. Key takeaways

Panama’s device sanitary registration is not inoperative; it sits in a state of statutory moratorium plus pending notice of commencement. Article 18 of Ley N° 92 (12 September 2019) empowers the health authority to set the date on which issuance of device sanitary registrations begins at public and private level. The wording is confirmed by official quotation in the CONSIDERANDO section of Resolución N° 003 de 15 de febrero de 2024. At the same time, the CONSIDERANDO on page 10 of DE 490 states officially that Ley 92 amends Ley 90, establishing a moratorium on device sanitary registration and setting a transitional procedure until issuance is implemented.

• The registration duty exists in law; what has been deferred is the issuance of the registration document.
• The delegation of the start date is express, not implied: the health authority sets the date, and no date has been fixed in the texts reviewed.
• DE 490 Article 69(2) carries the parenthetical cuando se expida after the words sanitary registration, an internal acknowledgement that routine issuance has not begun.
• Transitional periods under Article 23 of Ley 90 have all expired, but expiry of a period does not open a channel.
• Panama is moving categories one at a time from the drug system to the device system, each migration recorded in its own resolution.
• The moment a start date is published, the credential landscape can switch in a single step, which makes preparatory work worthwhile before any announcement.

2. Legal basis

Four instruments interact here: the statute that created the duty, the statute that suspended its issuance, the decree that built the transitional procedure, and the resolution that documented the substitute instrument in practice.

3. Expert insights

Insight 1. A moratorium is not the same thing as an exemption from the obligation. Article 23 of Ley 90 set transitional periods for existing products without a CCT — 18 months for class D, 24 for class C, 30 for class B and 42 for class A — as the deadlines within which those products had to obtain registration. Those deadlines expired long ago. But expiry of a deadline does not mean the registration channel must therefore be open, because Article 18 of Ley 92 placed the trigger in the hands of the health authority. This is the most frequently misread feature of the Panamanian system: the obligation has fallen due while the channel remains closed, and both statements are true at the same time.

Insight 2. DE 490 itself concedes that registration is not yet routinely issued. Article 69, item 2 describes the infringement of using a forged technical standard certificate or sanitary registration in a contractor selection process, and attaches the parenthetical (cuando se expida) — once it is issued — to the words sanitary registration. With one bracket, the legislature wrote the reality of the moratorium into the text of the decree. Details of this kind surface only when the original instrument is read, and they are precisely what secondary summaries tend to drop, which is why so much commentary describes a registration procedure that cannot currently be used.

Insight 3. The substitute mechanism during the transition is dual-track and category-by-category. The sequence runs from Resolución N° 1404 of 2020, which extended DNFD issuance of condom registrations, to Resolución N° 003 of 2024, which moved condoms to DNDM registration with a Certificado de Inscripción. The pattern is visible: Panama is migrating one category at a time from the drug system into the device system, issuing a resolution each time a category moves. A company should check whether its own category has already completed that migration before assuming it will be handled under the general device rules.

Insight 4. Once the start date is published, the transitional arrangement can switch in a single step. What Article 18 of Ley 92 authorises is a start date, a point in time rather than a gradual process. Combined with the progress of the new PAN/135 executive decree, there is a real possibility that the credential landscape changes at once rather than by degrees. Companies already holding a CCT should assess in advance whether that CCT can be converted into a registration, whether a fresh submission will be required, and how fees would be calculated. None of these questions has an answer in the texts currently in force, and they should be treated as open items to be tracked.

4. Practical recommendations

• Do not treat the expiry of the transitional periods as equivalent to the opening of registration; record and manage the two facts separately.
• Monitor three official channels at once: the DNDM pages on the MINSA website, the Gaceta Oficial, and WTO notifications.
• Companies already holding a CCT should prepare the product master file in advance so that a registration application can be filed quickly once a start date is announced.
• Search for migration resolutions by product category and confirm whether the category has already moved from the DNFD system to the DNDM system.
• Use conditional wording on the credential type in contracts and quotations, so that no commitment is tied to a registration that cannot yet be delivered.

5. Verification checklist

• □ Record the start-date delegation in Article 18 of Ley 92, with the official source of the quotation
• □ Record the moratorium wording in the CONSIDERANDO on page 10 of DE 490
• □ Record the cuando se expida parenthetical in Article 69, item 2 of DE 490
• □ Keep the expiry of transitional periods distinct from the opening of the channel
• □ Search for a migration resolution covering the product category
• □ Prepare a contingency for the announcement of a start date (master file, budget, contract terms)

Related reading: [Registro Sanitario or CCT: which one do you obtain today](/panama-medical-device-registration/registro-sanitario-vs-certificado-criterio-tecnico/) | [What the CCT is: definition, five-year validity, no fee, mandatory for public procurement](/panama-medical-device-registration/certificado-de-criterio-tecnico-explained/) | [Special requirements rising with risk: what classes B, C and D add](/panama-medical-device-registration/cct-special-requirements-by-risk-class/)

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