Medical devicesEl Salvador: New Salvadoran Technical Regulation RTS 11.03.02:21: Medical devices

El Salvador published a New Salvadoran Technical Regulation RTS 11.03.02:21: Medical devices. Requirements for the sanitary regulation of medical devices.

The notified Regulation establishes the technical provisions governing the sanitary regulation of medical devices in El Salvador, on the basis of the existing legal framework and the internationally harmonized principles of good regulatory practice.

The Regulation applies to establishments registered with the National Directorate of Medicines (DNM) and those that carry out manufacturing, import, export, distribution, storage, clinical research, operation of establishments, health registration, health surveillance, post-marketing surveillance and other related activities, as well as as users who are involved in the activities of the cycle of regulation of medical devices with or without marketing purposes, including members of the National Integrated Health System.

The requirements established in this RTS will be circumscribed to the phases of the medical device regulation cycle in relation to the functions defined above and to the actors linked to said functions, in accordance with the provisions of the Medicines Law and its regulations; This cycle comprises the following phases, which are linked in a continuous system of inspection, surveillance and control by the DNM:
a) Pre-marketing: which includes the authorizations and health surveillance related to the processes from product development, risk assessment, clinical research and production, including the authorization of establishments to carry out said activities, among other functions.
b) Marketing: which includes marketing authorization, known as sanitary registration authorization, import controls, quality control of products on the market, verification of GMP compliance, storage and distribution, among other functions.
c) Post marketing: refers to the health surveillance that is exercised during and after the use of medical devices, known as Technovigilance and that includes the investigation of events and incidents, health inspections, product quality control, among other functions.

The reference documents mentioned in the Regulation are:

• ISO 15223-1 Medical devices. Symbols to be used with the information to be provided by the manufacturer. Part 1: General requirements.
• Medicines Law. National Directorate of Medicines. Legislative Decree No. 1008, Official Gazette No. 43, Volume No. 394 of March 2, 2012. El Salvador.
• General Regulations of the Medicines Law. National Directorate of Medicines. Legislative Decree No. 245, Official Gazette No. 239, Volume No. 397 of December 20, 2012. El Salvador.
• RTS Medical Supplies. Medical Use Masks. Technical Specifications and Test Methods in their current version.