Medical Device Hosting
At Budnik Regulatory Affairs, we offer a specialized Medical Device Hosting service, acting as a local regulatory representative before ANMAT, allowing both domestic and international companies to register and import medical devices in Argentina without the need to hold their own regulatory licenses.
This model provides manufacturers with a solid, reliable, and flexible regulatory structure, without requiring direct commercialization of the products. As a result, companies are able to design, select, and manage their own local distribution and commercialization network, fully aligned with their strategic and commercial objectives.
We hold the regulatory authorizations granted by ANMAT that allow us to register, under our ownership, different types and risk classes of medical devices, assuming the corresponding regulatory responsibilities and ensuring ongoing compliance with applicable regulations.
This service represents an effective solution for an orderly and agile entry into the Argentine market.
A Service That Covers the Entire Product Lifecycle
Building on the Medical Device Hosting service, we provide comprehensive support throughout the entire regulatory and operational lifecycle of the product in Argentina, including:
Definition of the regulatory strategy from the early stages of the project, including feasibility assessment, regulatory analysis, timeline planning, and alignment of the regulatory pathway with the client’s business model.
Regulatory Project Advisory
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Preparation, submission, and follow-up of medical device registrations before ANMAT, including the management of technical and administrative requirements, as well as ongoing maintenance of the registration throughout the entire product lifecycle.
Local Sanitary Representation
Regulatory support for the importation process, including oversight of import authorizations, coordination with logistics operators and warehouses, and assurance of traceability in accordance with applicable regulations.
Importation of Medical Devices
Implementation and management of post-market surveillance systems, including monitoring, reporting, and follow-up of adverse events, in coordination with manufacturers and regulatory authorities, ensuring ongoing compliance with local vigilance requirements.
Pharmacovigilance
Check for the risk classes and type of products covered by our service
Send your inquiry completely free of charge to: info@bpregulatoryaffairs.com
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