Sanitary registration: the question asked of peptides but not of exosomes

A reasonable question, applied halfway

When a physician in Panama evaluates a peptide, the first question is usually whether it has a sanitary registration. That is the right question. What stands out is how rarely it is heard about the exosomes, polynucleotides (PN/PDRN), skin boosters and "stem cell" products injected or microneedled in aesthetic practices every day. This article applies the same standard to all of them, using regulations and official notices as sources. It does not claim that any specific brand lacks registration: it describes what the law requires and what can (and cannot) be checked publicly.

What the law requires

Law 419 of 1 February 2024, which replaced Law 1 of 2001, states that «todo producto regulado por la presente Ley deberá registrarse ante la Dirección Nacional de Farmacia y Drogas» ("every product regulated by this Law must be registered with the National Directorate of Pharmacy and Drugs", art. 4) and that these products «requieren de la obtención de un registro sanitario» ("require a sanitary registration", art. 25)¹. Art. 156.1 classifies as a very serious offense «Comercializar un producto sin registro sanitario, salvo las excepciones autorizadas por esta Ley» ("marketing a product without a sanitary registration, except for the exceptions authorized by this Law"), and art. 150 sets fines from B/.500 to B/.25,000¹.

Definitions matter. Art. 3 defines a cosmetic (no. 22) as a «Producto o formulación de aplicación local usada en las diversas partes superficiales del cuerpo» ("product or formulation of local application used on the various superficial parts of the body") and a biological product (no. 75) as a «Sustancia que es obtenida a partir de organismos vivos o de sus tejidos» ("substance obtained from living organisms or their tissues")¹. Law 90 of 2017 defines a medical device as an article that «No logra su efecto principal perseguido por medios farmacológicos, inmunológicos o metabólicos» ("does not achieve its principal intended action by pharmacological, immunological or metabolic means")³.

One vial, three possible doors

Depending on how it is classified, the same product enters through one of three routes. What follows is our reading of the definitions cited, not a Ministry of Health ruling:

• Cosmetic. The official procedure requires a qualitative and quantitative formula, a certificate of free sale, a Good Manufacturing Practice certificate, product studies and a sample; the procedure page still cites Law 1 of 2001 and Decree 178 of 2001 as its legal basis². A product registered as a cosmetic but injected or microneedled into the dermis falls, in our view, outside the definition of "local application" on "superficial parts"¹.
• Biological product. A vesicle preparation obtained from cell cultures or tissues fits the literal definition of "obtained from living organisms or their tissues"¹.
• Medical device. Hyaluronic acid gels act by physical means. In the European Union, injectable substances for dermal filling are in group 3 of Annex XVI of the Medical Device Regulation even without a medical purpose, with their own common specifications (Regulation 2022/2346) and CE marking¹⁸. PN products are distributed in Europe as medical devices, according to the conflict-of-interest statement of a systematic review¹⁴.

The practical consequence: the vial's label ("cosmetic", "professional use", "device") does not by itself define the legal category. Composition and use do, and that category determines which Ministry directorate should have issued the registration.

Medical devices: a 2017 law still being regulated

Law 90 says a device registration «autoriza la importación, exportación, comercialización y uso» ("authorizes import, export, marketing and use", art. 15), classifies marketing without it as a very serious offense (art. 37.1) and set a phased entry into force by risk class, from 18 to 42 months (art. 23)³. But the 2025 draft regulation notes that Law 92 of 2019 provided that, «de manera transitoria y mientras se habilite gradualmente la emisión de Registros Sanitarios de Dispositivos Médicos» ("on a transitional basis and while the issuance of Medical Device Sanitary Registrations is gradually enabled"), technical criterion certificates would be issued for public-sector purchases⁵.

That draft was open for public consultation from 15 October to 19 December 2025⁶, and the Ministry announced it would extend the consultation at the request of the Chamber of Commerce, with meetings in January and February⁷. Its art. 223 again proposes phasing in the registration obligation: 3 months for class D, 6 for class C and 9 for class B after entry into force⁵. As of this article's date we did not find the decree published in the Official Gazette.

Where can a physician check a registration? For medicines, the pharmacy directorate tells the public to verify the registration number on its FADDI platform²¹ (we could not open it from our network). For devices, the Medical Devices Directorate's page offers laws, decrees, forms and notices (the latest from December 2023), but links to no public search tool for registered products⁴. For a skin booster or a PN product classified as a device, we found no public registry to check.

What is documented

Stem cells. On 31 August 2026, La Prensa reported that the Ministry of Health inspected two establishments offering stem cell treatments and opened files over missing operating permits, documentation deficiencies and «productos sin registro sanitario» ("products without sanitary registration")⁹. The same report notes that Executive Decree 179 of 2018 recognizes hematopoietic stem cell transplantation as the evidence-based use, and that other uses must take place within authorized research protocols; the National Research Bioethics Committee sent the Ministry at least six notifications between 2015 and 2025⁹. Committee members wrote in Stem Cell Reports that lack of enforcement contributed to that market's expansion¹⁰. More in Stem cells in Panama.

Silence in the notices. The 29 notices the pharmacy directorate lists from September 2025 to September 2026 include alerts on counterfeit or illegal products relayed from agencies in Colombia, Mexico, Brazil, Peru and Argentina (among them a specific counterfeit lot of DYSPORT® 500 reported by Argentina's ANMAT, notice 013-DNFD-2026), the temporary closure of Cosmetic Plus, S.A. and a warning about an establishment not authorized to manufacture cosmetics⁸. No title mentions exosomes, polynucleotides, skin boosters or fillers⁸. That does not prove these products are registered, or that they are not: it shows they have not been the subject of public alerts.

Exosomes and PN outside Panama. The FDA states: "There are currently no FDA-approved exosome products"¹¹. On 14 August 2026 it sent a warning letter to R3 Medical Companies over products such as ReBellaXO, which it called unapproved new drugs without a biologics license, noting that their process "does not appear would isolate exosomes"¹². For PN, the available systematic review included 9 studies of low to moderate quality, with 219 patients¹⁴, and a randomized trial comparing PN with polycaprolactone was retracted¹⁵. We go deeper in Exosomes versus peptides.

A note on research reagents

Reagents sold for research are a legal category distinct from products sold for clinical use. In the US, for example, diagnostic products in the laboratory research phase must carry the statement "For Research Use Only"²⁰, and Panama's Law 90 allows authorizing the import of unregistered devices «Para fines de investigación y docencia» ("for research and teaching purposes"), upon request³. The difference is the declared destination: a product marketed for application to patients falls under the registration requirement, whatever its category.

The same question, for everyone

• What is the Panamanian sanitary registration number, and which directorate issued it: Pharmacy and Drugs or Medical Devices¹³?
• In which category is it registered (cosmetic, medicine or biological, device), and does that category match the route of application used in the clinic¹³?
• What authorization does it hold in its country of origin, and for exactly what use¹⁸?
• If it is a cell-derived product, is it being offered outside an authorized research protocol⁹?