Pantho SRL also offers license hosting services as Registry Holder for medical devices registries without commercialization of them, allowing manufacturing companies to select and set up their own local distribution and marketing network in a flexible manner and adjusted to the commercial objectives of the manufacturer.
We currently have the ANMAT regulatory authorizations that allow us to register different types and risk classes of medical products in our name.
Our Registry Holder services include:
- Preparation of technical documents and their submission for approval by ANMAT
- Follow-up of the process during the technical evaluation
- Translation service through official translators
- Execution of complementary tests for medical products to be developed in Argentine laboratories.
- Annual maintenance of registries.
- Civil liability regarding the performance of the products in the Argentine market
- Periodic audits on the Distributors designated by the client as Commercial Representants to verify compliance with the regulatory and particular requirements of the products.
- Own Technovigilance System to respond to the manufacturer and the regulatory authorities in the event of adverse events.
- Customer support in the labeling of imported products to comply with current Argentine regulations.
- Control of import authorizations to ensure the traceability of imports according to regulatory standards.