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Service Regulation in Costa Rica

Our Office offers the Sanitary Registration service, with a team of lawyers and specialists who can provide exclusive assistance for your needs.

We offer our services for the following products:

  • Medicines

  • Medical Devices

  • Foods and Drinks

  • Cosmetic and Hygienic Products

  • Route Changes

Renewal of Health Registration:

This procedure is administered together with the Ministry of Health, requesting the extension of the validity of the license to continue, commercialize, manufacture or repackage the product. The sanitary registration is valid for 5 years and its renewal is carried out 90 days before the end of the term, if this renewal is not processed within this period, the registration must be processed as new and comply with all the corresponding requirements.

Procedures for Modifying Information in Health Registration:

The registration holder or legal representative during the term of the registration must notify the Ministry of Health of any modification or update made to the registration or product, and must pay a fee to the Ministry of Health according to the product category.

It is important to point out that these procedures can only be carried out by the holder or legal representative of the registration, and not by third parties.

Advice on the General Practice of Health Registration:

Our Office takes care of the entire process of registering each product, as well as keeping your health records up-to-date, thus providing personalized monitoring of each product.

Product Registration:

To start the registration process for each of the products, we offer advice and support for each of the necessary requirements for each type of product.

See below our complete DRPIS process flow

Fluxo Etapas EN Costa Rica Process DRPIS LATAM 300x181

Passarini Group is a company that has the best specialists in Regulatory Consultancy of Medical Products, applying the One Stop Shop concept daily in your company with practical solutions.

Contact us for more information about service regulation in Costa Rica.