Navigating Medical Device Registration in Ecuador: A Comprehensive Guide through ARCSA Regulations and Latest Requirements

Regulatory Authority

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA)

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA)is the technical body responsible for the regulation, technical control, and health surveillance of the following products: processed foods, food additives, processed water, tobacco products, general medicines, nutraceutical products, biological products, processed natural products for medicinal use, homeopathic medicines, and dental products; medical devices, biochemical and diagnostic reagents, hygienic products, pesticides for domestic and industrial use, manufacture, and distribution.

Link for Regulatory Authority

https://www.controlsanitario.gob.ec/

Local Regulations

• Health Law
• Executive Decree No. 1583, RO/Sup 349, June 18, 2001
• Reglamento y Control Sanitario de Dispositivos Medicos y Dentales (2009)
• Reglemento Para El Registro y Control Sanitario de DispositivosMédicos, reactivosBioquimicos y Diagnostico y ProductosDentales (2013)
• Ministerial Agreement No. 0000230, 30 May 2007 (Ley No. 2000-12)
• Ministerial Agreement No. 205
• Resolution ARCSA-DE-026-2016-YMIH (regulation on registration and control of medical devices) amended by Resolution ARCSA-DE-030-2018-JCGO

Classification of Medical Devices

Listing or Registration Requirements

• Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) is responsible for medical devices in Ecuador.
• Determining the proper classification for medical device is critical to ensuring a smooth registration process.
• Companies without an establishment in Ecuador are required to appoint an Authorized Representative as an in-country representative and liaison with ARCSA. Having an independent firm control the registration for device(s) is critical if onedoes not have a direct sales office in Ecuador.
• Technical documentation provides proof that product is safe and effective.

Documents Required for Ecuador Medical Device Registration

1. Authorized representative’s documents

• The appointment of the authorized representative
• Authorization granted by the owner of the product for registration purposes – duly legalized authorization from the owner of the product, in which the applicant is authorized to obtain the medical device registration in Ecuador. The responsibilities of the registration holder should be described in detail and clearly expressed
• Applicant’s operating permit granted by the competent health authority
• List of medical devices to be registered
• Fee receipt

2. Manufacturer’s Documents

• Certificate of Free Sales, Certificate of Foreign Government, Export Certificate, or equivalent document in which it is declared: commercial name of the product, description of the product, manufacturer(s), and the owner of the product.
• GMP Certificate granted by the health authority of the country of origin, or the ISO Certificate granted by an accredited institution. All copies should be notarized.

3. Technical Documentation

• Quality reports issued by the manufacturer including signature, name, and position of the responsible person
• Sterility reports issued by the manufacturer including signature, name, and position of the responsible person
• Specifications of the finished product
• Product description – Description of the functional components, parts and structure of the medical device including lists, diagrams, images, or drawings of the functional components
• Description of the raw materials
• Stability reports signed by the responsible person who carried out the tests
• Interpretation of the batch and series code, with signatures, names, and positions of responsible persons
• Labels and instructions for use, catalogs, brochures etc. Labels must be in Spanish or contain other languages so long as it includes Spanish. Information on the name of the product, brand name, contents of the packaging, etc. must be included on the label (Reglamento y Control Sanitario de
• Dispositivos Medicos y Dentales , Art.
• Description and technical specifications of the primary and secondary packaging
  Information on the manufacturing process including the flow chart of the manufacturing process of the medical device for human use
• Bifunctionality reports
• IEC 60601 certificates (if applicable)
• Biocompatibility Studies based on ISO 10993 (if applicable)
• Scientific evaluation of the product

Who should make this Communication?

• Manufacturer
• Authorised Representative
  

When to make this Communication?

Before placing a medical device into the market.

Market of Medical Devices

The Medical Devices market in Ecuador is poised to achieve a revenue of US$838.80 million in 2024. Among the diverse segments within this market, the largest is projected to be US$130.60 million, contributing to a total market volume of US$1,075.00 million in the same year. Over the forecast period from 2024 to 2028, the market is expected to experience a robust annual growth rate (CAGR) of 6.40%, reaching a market volume of US$1,075.00 million by 2028.

In a global context, the United States is anticipated to lead in terms of revenue, with an expected amount of US$182.00 billion in 2024. Ecuador is currently witnessing a surge in the demand for advanced medical devices, driven by the country’s expanding healthcare infrastructure and a heightened emphasis on enhancing patient care.

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk