Published on January 05, 2021
El Salvador | Press Release from the National Directorate of Drugs
Press Release of December 1st, 2020 | The National Directorate of Drugs. through the Unit of Registration of Establishments of Powers, and the Division of Health Registration, reports:
- That the RTCA 11.03.5911. OF "PHARMACEUTICAL PRODUCTS. MEDICINES FOR HUMAN USE. HEALTH REGISTRATION REQUIREMENTS", and the RTCA F1.03.37:07. of "HYGIENIC PRODUCTS. HEALTH REGISTRATION AND REGISTRATION OF HYGIENIC PRODUCTS", define the "holder of the product or registration holder" as the natural or legal person who owns the product.
- By the principle of analogy, the previous provisions regulating the registration of pharmaceutical products shall be applied to medical inputs, since there is a relationship of similarity and identity between these two types of products. Hence, licenses must be requested in the name of the owners of the products, because importers and distributors only carry out the activity of bringing the product into the country for the purpose of marketing it.
- In that sense, new registrations for medical devices and inputs must be requested in the name of the manufacturers' owners; therefore, importers and distributors of medical devices and inputs may not be holders of health registrations.
- The importers and distributors of medical devices and inputs that wish to carry out this activity may manage the health registration in favor of the owner and will be registered in it as authorized distributors.
- The registrations granted prior to the issuance of this statement shall be valid until their renewal, at which time they must adjust to the new regulation.
- Likewise, it is established that the appointments of the "responsible professional" and "responsible attorney" must be assigned by the owner manufacturer of the product directly or through a representative in El Salvador.
The above will come into effect as of March 1st, 2021.