Regulatory Affairs
Medical Device Sanitary Registration
Compilation of sanitary registration dossiers to obtain approval according to Decree 34482-S of the Ministry of Health of Costa Rica
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Classification and grouping of medical devices
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Follow-up of the file in the Ministry of Health
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Communication with translators and notaries.
Documentation prepared with experience and success in approvals. Identify with the mission of the client's company will bring success in each project.
Holder of Sanitary Registration
Legal representation of manufacturers of medical devices of foreign origin who wish to commercialize their products into the Costa Rican market.
Regulatory Strategy
We help your company to plan the regulatory strategy to enter your products in the market according to your sales strategy.
Sanitary Permit
Procedure to obtain the Operating Health Permit from the Ministry of Health of Costa Rica
Certificate of Free Sale for Exportation
Procedure for obtaining the Certificate of Free Sale of the Ministry of Health of Costa Rica for exportation.
Official translations and digital notarizations for the procedure to obtain the Health Registry of the Ministry of Health of Costa Rica
Translations and Notarizations
Tecnovigilance
Procedure of Technosurveillance according to the decree of the Ministry of Health of Costa Rica