On April 28, 2026, the Executive Director of the National Agency for Regulation, Control and Health Surveillance (“ARCSA”) issued Resolution No. ARCSA-DE-2026-003-DASP, through which the Substitute Technical Health Regulation for Obtaining the Sanitary Registration, Control and Surveillance of Medical Devices for Human Use (the “Regulation”) is enacted. This Regulation focuses on establishing new legal and technical requirements to ensure the quality, safety, and efficacy of medical devices for human use, as well as regulating the procedures for registration, modification, re-registration, control, and surveillance of such products.

Below are the most relevant changes:

1. New modalities to obtain sanitary registration. The applicant may obtain the sanitary registration of a medical device for human use through general registration or through a simplified registration process. This latter modality allows ARCSA to recognize the sanitary registration or its equivalent issued by high-surveillance agencies that are members of the International Medical Device Regulators Forum (IMDRF), provided that the conditions set forth in the Regulation are met. For this simplified process, an evaluation period of thirty (30) business days is established, not including the time taken by the applicant to remedy observations.
2. Update of technical and documentary requirements. More detailed requirements are established to demonstrate the quality, safety, and efficacy of medical devices, depending on their type and level of risk. Among others, requirements are regulated regarding labels, inserts or instructions for use, description of components, raw materials, manufacturing processes, stability studies, sterility certificates, biocompatibility studies, clinical studies, performance studies for in vitro diagnostic devices, ISO 13485 certificates, GMP certificates, IEC certificates, and authorizations applicable to devices that use ionizing radiation. Likewise, requirements for imported products are regulated, including the Free Sale Certificate or its equivalent and the authorization of the product holder.
3. Classification of medical devices, medical software, and new technologies. The classification of medical devices for human use is updated based on risk level and device type. The Regulation incorporates technical criteria applicable to active, invasive, non-invasive, and in vitro diagnostic medical devices. It also includes specific rules for software as a medical device, medical devices enabled for machine learning, and other products associated with medical technologies, taking as reference internationally recognized criteria and risk matrices.
4. Re-registration, modifications, and final labeling. The sanitary registration will be valid for five (5) years and may be renewed for equal periods. The re-registration application must be submitted at least ninety (90) business days in advance and no more than six (6) months prior to its expiration. Likewise, the procedure for modifying the sanitary registration and the cases in which it is not necessary to obtain a new registration are regulated in detail. Additionally, it is established that, within a maximum period of one (1) year from obtaining the sanitary registration and prior to the commercialization of the product, the holder must submit to ARCSA the final labels with the printed sanitary registration number granted.
5. Voluntary cancellation of sanitary registration. A specific procedure is incorporated for the holder of the sanitary registration to voluntarily request the cancellation of the registration of a medical device. For this purpose, the holder must submit a voluntary cancellation request, the appointment of the sanitary registration holder, and a market withdrawal strategy. It is also established that the voluntary cancellation request will not incur any cost.
6. Conditioning and labeling of imported medical devices. Medical devices for human use that are imported may be conditioned within national territory prior to commercialization in order to comply with sanitary registration requirements. For this purpose, the establishment where the conditioning takes place must have a valid certificate of Good Manufacturing Practices for medical devices or an ISO 13485 certificate registered with ARCSA. In the case of carrying out only labeling activities, the establishment must have a valid certificate of Good Storage, Distribution and/or Transportation Practices issued by ARCSA. In all cases, these activities must not affect the stability of the product, nor the integrity or sealing of the primary packaging.
7. Registration of the ISO 13485 certificate with ARCSA. The procedure for registering the ISO 13485 certificate with ARCSA is regulated, applicable to national laboratories manufacturing medical devices or manufacturers of in vitro diagnostic biochemical reagents for human use. For this purpose, they must submit the corresponding application and attach the valid certificate issued by a conformity assessment body accredited or recognized by the Ecuadorian Accreditation Service (SAE), or designated by the Ministry of Production, Foreign Trade and Investments (MPCEI), as applicable.
8. Post-registration control, technovigilance, and new prohibitions. Post-registration control is strengthened through inspections and verifications based on a risk management approach. ARCSA may carry out Type 1 controls, focused on the visual verification of labels, inserts, shelf life, and storage conditions; and Type 2 controls, which include sampling for quality analysis. In addition, the obligation to collaborate with the National Technovigilance System is reinforced through the identification, prevention, and reporting of adverse events. The Regulation expressly prohibits the reuse of single-use medical devices and the fractioning of medical devices, which must be marketed in accordance with the commercial presentation authorized by ARCSA.

In accordance with the Regulation, ARCSA will issue the necessary guidelines for the application of the Regulation within a period of nine (9) months from its issuance. Likewise, a process for the reclassification of medical devices with a valid sanitary registration is foreseen.

On the other hand, the Resolution expressly repeals Resolution No. ARCSA-DE-026-2016-YMIH and its amendments, as well as Resolution No. ARCSA-DE-2023-033-AKRG, except for their amending provisions.

The Regulation will enter into force within nine (9) months from its issuance, that is, as of January 28, 2027, without prejudice to its publication in the Official Gazette.

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