一.Ecuadorian Medical Device Regulatory Authority
The regulation of medical devices in Ecuador is primarily carried out by the National Agency for Regulation, Control, and Health Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, or ARCSA), which is primarily responsible for market access, oversight, and enforcement regarding medical devices.
Regulatory Authority Website: https://www.controlsanitario.gob.ec/
二.Regulatory Requirements
ARCSA-DE-026-2016-YMIH (Regulations on the Registration and Control of Medical Devices)
Risk Classification of Medical Devices and IVD Products
Under Resolution ARCSA-DE-026-2016-YMIH, Ecuador classifies medical devices and in vitro diagnostic (IVD) products into four risk classes based on risk level and intended use: Class I (Low Risk), Class II (Low-to-Moderate Risk), Class III (Moderate-to-High Risk), and Class IV (High Risk).
三.Requirements for the Registrant
Titular del Registro Sanitario (Health Registration Holder): Refers to the legal owner of the product’s health registration certificate, typically the manufacturer (product owner).
Titular del Registro Sanitario (Health Registration Holder): Refers to the legal owner of the product’s health registration certificate, typically the manufacturer (product owner).
Representante Autorizado / Solicitante (Authorized Representative/Applicant): A legal entity or natural person registered locally in Ecuador, authorized by the Titular, responsible for submitting the registration application to ARCSA, handling subsequent matters, and serving as the point of contact with regulatory authorities.
Qualification requirements for the Authorized Representative: Must be a legal entity (company) or natural person legally established in Ecuador and hold a valid Permis de Funcionamiento (Operating Permit) with ARCSA. Must possess the relevant qualifications for importing, distributing, or commercializing medical devices.
四.Essential Requirements for Market Authorization
① Both MD and IVD products require a GMP certificate issued by the health authorities of the country of origin or an ISO certificate issued by an accredited body;
② A Free Sale Certificate (FSC) from the country of origin or from the United States, Canada, Australia, Japan, the European Union, or South Korea must be provided, and it must be notarized under the Hague Convention or by an embassy;
③ Technical documentation for products of each risk class must be submitted in accordance with the relevant regulations.
五.Registration Languages
Labels and instructions for use must be provided in both English and Spanish; other documents may be submitted in English only.
六.Exemptions from Registration
The following medical devices are exempt from registration:
① Custom-made medical devices for human use (manufactured without the need for a health record);
② Medical devices for human use intended solely for scientific research and not intended for commercialization;
③ Accessories or components of medical devices that are to be included in the health record of the main device;
④ Parts or spare parts of medical devices;
⑤ Software accompanying single-use devices that is not sold separately.
七.Registration Process, Timeline, and Fees
- Registration Process
Standard Registration Process: Determine product classification → Select registration pathway → Prepare registration documents → Submit application to ARCSA → Official review (2–6 months) → Obtain certificate (valid for 5 years)
- Official Review Timeline
Typically 2–6 months; the exact duration depends on the product’s risk class and the completeness of the documentation.
- Registration Fees
New product registration: $905
License amendment: $95
License renewal: $185
八.Frequently Asked Questions
Is a CE certificate required for medical device registration in Ecuador?
How long is the medical device registration certificate valid in Ecuador?
How long does it take to obtain an Apostille in Ecuador?
