1. A health registration is a permit or authorization issued by the health authority of a country for the marketing and use of a product or service in the healthcare sector.

“This permit is necessary to ensure that products or services marketed in the market comply with legal and regulatory requirements to protect the health and safety of people and animals,” says our lawyer, Fátima Espinal.

According to our expert, health registration is mandatory for medicines, medical devices, biotechnological products, food, and cosmetics marketed in the market. It requires the submission of detailed information about the composition, quality, efficacy, and safety of the product or service.

Espinal mentions that in El Salvador, the entities responsible for supervising products for human and animal consumption are the Ministry of Health (MINSAL), the Ministry of Agriculture and Livestock (MAG), and the National Directorate of Medicines (DNM).

“In many countries, including El Salvador, the process of obtaining health registration is rigorous and may require clinical trials and comprehensive testing to demonstrate the effectiveness and safety of the product or service before it is approved for marketing. Once granted, the product or service can be legally marketed and sold,” explains Espinal.

Our specialist indicates that the requirements for the registration of national products are divided into two parts: one through an online dossier and another in a physical dossier.

“The digital dossier requires a list of ingredients, the label with the technical regulation requirements applicable to the product, and a copy of the current sanitary license or operating permit for the factory and warehouse. In the case of contract-manufactured products, the health registration must be carried out by the owner,” says our lawyer.

For the physical dossier, Espinal explains that it must be signed by the attorney-in-fact or the owner, include the list of ingredients, labels with the technical regulation requirements applicable to the product (original for renewal and draft for a new health registration).

According to Espinal, the procedure for obtaining a health registration or its renewal is as follows:

1. 1. Register as a user in the Environmental Health Information System at: https://sisam.salud.gob.sv.
   2. Create an online application for a new health registration or for a renewal of a health registration.
   3. The system will send an email indicating that the application was successfully created.
   4. A technician from the Food and Beverage Unit will review that the application was created correctly, and the laboratory will classify the food or beverage.
   5. The Environmental Health Information System will send an email to the user indicating that they must proceed with the payment for the health registration and laboratory analysis costs.
   6. Make the payment online or at MINSAL collection offices.
   7. Submit samples to the MINSAL National Reference Laboratory.
   8. Present the physical dossier to the Food and Beverage Unit.
   9. The system will send an email notifying changes in the status of the application, and the user can check via the web.

“It is important to note that the health registration process may vary depending on the type of product or service you wish to register, and the health authority may require additional information during the evaluation process,” advises Espinal.

If you have more questions about this or other topics, you can contact us through our social media or by visiting our offices located at Calle Cuscatlán, #4312, Colonia Escalón, San Salvador, El Salvador.