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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

  • Classification and grouping of medical devices

  • Follow-up of the file in the Ministry of Health

  • 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

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