Registro Sanitario or CCT: which credential do you actually obtain now

1. Key takeaways

Panama’s legal system contains two product credentials side by side: the sanitary registration for medical devices (Registro Sanitario de Dispositivos Médicos) and the technical standard certificate (Certificado de Criterio Técnico, CCT). The one that can actually be obtained today is the CCT, because Article 18 of Ley N° 92 leaves the starting date for issuing device sanitary registrations to the health authority. Until that opening is phased in, DNDM issues the CCT. The point is supported directly by an official text: the CONSIDERANDO section of Resolución N° 003 de 2024 states that Article 18 of Ley 92 provides that the health authority shall set the date on which issuance of device sanitary registrations begins at the public and private level, and that while issuance is being progressively opened, technical standard certificates will be issued for public-sector condom procurement.

• The two credentials are not interchangeable options; one duty is suspended by statute and the other instrument carries the market in the meantime.
• Ley 90 Article 15 defines the sanitary registration as the document authorising import, export, sale and use, at both public and private level.
• DE 490 Article 21 gives the CCT a five-year validity from issuance, makes it mandatory for public procurement, and states that the document carries no fee.
• The mandatory scenario for the CCT is public procurement; private-channel obligations are not identical and follow a different logic.
• Resolución N° 003 de 2024 shows a third instrument in practice: the Certificado de Inscripción, issued category by category.
• Budget models built around an official registration fee are badly distorted in Panama, because that fee is zero for the CCT.

2. Legal basis

The table maps the two credentials and their interaction to the instruments that create them. Read together, the provisions show a suspended obligation, a substitute instrument, and an official confirmation of that arrangement.

3. Expert insights

Insight 1. This is not a choice between two parallel options; it is one suspended track and one substitute track. The official CONSIDERANDO on page 10 of DE 490 uses the word moratoria — suspension, deferral — and not alternativa, an alternative. The precise meaning is that the duty to issue sanitary registrations has been suspended by statute, and that during the suspension the CCT serves as the transitional credential. The distinction matters commercially: a company cannot decide by asking which route is cheaper or more advantageous, only by asking which route is currently open. Planning built on the assumption of a free choice will produce schedules that cannot be delivered.

Insight 2. The two credentials serve different scenarios, and that is the key commercial decision. The third paragraph of Article 21 of DE 490 says that all devices procured by public bodies require a CCT. The mandatory scenario is therefore public procurement. Private-channel requirements are not equivalent to public ones. This is the institutional background described in the Swiss Chamber’s 2024 overview of Panamanian law: devices traded privately do not require sanitary registration where the importer or distributor holds a business licence, but sales to government, whether by public tender or direct contract, require a technical standard certificate. A supplier quoting a project should establish the channel first and fix the credential second.

Insight 3. The CCT is free, and this is widely underestimated. The last sentence of the third paragraph of Article 21 reads y este documento no tendrá costo — this document shall carry no cost. In Panama’s compliance cost structure the official fee for a CCT is zero. The real cost sits elsewhere: obtaining ISO 13485 certification, apostille, translation by a public authorised translator, and local licence-holding arrangements. A quotation model that loads cost onto an official registration fee will be seriously inaccurate for Panama, and will usually understate the third-party elements that actually determine the project budget.

Insight 4. Resolución N° 003 de 2024 reveals a third instrument: the registration certificate. Article Octavo of that resolution provides that, for condom importers that have completed all requirements, DNDM issues a Certificado de Inscripción rather than a sanitary registration certificate. This is currently the closest official template in Panama to a product registration procedure, with an official fee of B/.300.00 and a reply period of 30 working days. The signal for companies is that Panama is rebuilding product access by registering category by category rather than opening registration across the board in a single step.

4. Practical recommendations

• Before project launch, confirm with DNDM whether sanitary registration has been opened at that point in time; rely on official notices and treat the year ranges and status descriptions on industry pages as unreliable.
• Split preparation by channel: public procurement projects are prepared against the CCT, private channels against the business licence plus the requirements in force at the time.
• Remove the official registration fee from the budget model and concentrate cost on quality system evidence, certification, translation and local licence-holding arrangements.
• Track category-specific registration resolutions, with condoms as the first template; companies in the same category should benchmark against that procedure and its fee.
• Set a regulatory watch on PAN/135: once the new executive decree is published, the credential landscape could change in a single step.

5. Verification checklist

• □ Confirm which credential can currently be obtained (CCT, or a sanitary registration that has already been opened)
• □ Confirm whether the target channel is public procurement or private sale
• □ Record the five-year CCT validity and the no-fee rule (Article 21)
• □ Record the delegation of the start date in Article 18 of Ley 92
• □ Search for a dedicated registration resolution covering the product category
• □ Set a legislative watch on PAN/135

Related reading: [From zero to market: a ten-step compliance roadmap for Panamanian devices](/panama-medical-device-registration/panama-medical-device-registration-roadmap/) | [Article 18 of Ley 92 and the registration start date: how the moratorium works](/panama-medical-device-registration/ley-92-moratoria-registro-sanitario-start-date/) | [The thirteen general CCT requirements, item by item (Article 36 of DE 490)](/panama-medical-device-registration/cct-general-requirements-13-items/)

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