A registro sanitario is commercial market authorization under Decreto 4725 de 2005. It is not a clinical-trial recommendation. Class I and IIa use the automatic route. Class IIb and III are processed in ninety business days once the file is complete. The term is ten years. The first-in-human CRO for the Americas.
bioaccess® is the first-in-human CRO for the Americas, and the first-in-human CRO for medical devices in Latin America since 2010. Headquarters are in Miami. The Colombia hub states a Colombian legal entity and office. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. This spoke does not recommend a clinical trial.
Decreto 4725 de 2005 article 5 classifies devices, by the manufacturer, as class I, IIa, IIb, or III, using the rules in article 7. Article 17 says class I and IIa devices that are not controlled technology need a registro sanitario automático before production, import, export, processing, packaging, storage, sale, or commercialization. Article 16 says class IIb and III devices that are not controlled technology need a registro sanitario on the evaluated route for the same activities.
Article 22(b) says that when the automatic-registration requirements are complete, INVIMA issues the administrative act within two days after evaluation of the documents. That is after evaluation, not a promise of two days from an incomplete filing. Decreto 582 de 2017 says INVIMA processes registro sanitario or marketing-permit applications for class IIb and III in ninety business days once all technical and legal requirements are on file. Article 31 sets the term at ten years from the administrative act. Article 32 says the renewal application is filed three months before expiry.
Under Decreto 4725 de 2005, class I and IIa devices that are not controlled technology use registro sanitario automático (article 17). Class IIb and III use the evaluated registro sanitario (article 16). The manufacturer’s classification follows article 5 and the rules in article 7. This page describes market authorization. It does not place a clinical trial.
No. A registro sanitario authorizes commercial activity. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. Drug, biologic, and vaccine trials are described on the Colombia hub, not on this registration page.
Article 29(b) requires a certificate from the competent authority in the country of origin that the product is authorized for production or commercialization there. If the product is not used in the country of origin, the applicant adds a free-sale certificate from a reference country. The article names the European Economic Community, the United States, Canada, Japan, and Australia, or countries with a mutual-recognition agreement.
Article 31 fixes the term at ten years. The Colombia hub already quotes the U.S. Commercial Service’s warning that a registration held in a distributor’s name is difficult to move during that life, and it already states that bioaccess® holds the registro as titular through its Colombian entity while distributors act as importers of record. This spoke does not add a new holder structure and does not publish a subscription fee.
Article 32 says the renewal is filed with INVIMA three months before the registro or marketing permit expires, and that a request outside that term is processed as a new application. Plan the renewal from the issue date.
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
First-in-human trials in El Salvador
Decreto 4725 de 2005 articles 16 and 17 require a registro sanitario, automatic or evaluated by class, before production, import, and commercialization of devices that are not controlled technology. Controlled-technology equipment uses the marketing permit in the same decree. This page is that commercial file.
Article 17’s route for class I and IIa devices that are not controlled technology. Article 22(b) says INVIMA issues the act within two days after evaluation when the requirements are complete. Later verification is part of the same article’s inspection powers.
Ten years from the administrative act, under article 31 of Decreto 4725 de 2005. Renewal is filed three months before expiry under article 32.
For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
No. Statutory clocks are not a tariff. The market-access page describes the registration service. This spoke does not copy a subscription amount or a percentage.
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