Chapter 1 Ecuadorian ARCSA Administration Information Abstract

1. Administration and Abstract

The regulation of medical devices in Ecuador is mainly carried out by the National Agency for Regulation, Control and Health (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, ARCSA), which is mainly responsible for market access, supervision and penalties for medical devices.

2. Administrative Regulation

ARCSA-DE-026-2016-YMIH

3. Risk Level Classification of Medical Device and IVD Products

The medical device regulatory authority in Ecuador classifies medical devices according to ARCSA-DE-026-2016-YMIH (Medical Device Registration and Control Regulation), which classifies medical devices and in vitro diagnostic reagents into the following four main categories based on the level of risk and intended use of medical devices: Class I, Class II, Class III, Class IV.

4. Entry Requirements

Both MD and IVD require a GMP certificate issued by the health authority of the country of origin or an ISO certificate issued by an accredited body.

Free marketing Certificate (FSC) form Country of origin or from the following countries (USA, Canada, Australia, Japan, EU and Korea) of the manufacturer or exporting country or high health supervisory authority is acceptable, and is notarized by the Hague or Embassy.

5. Registration Language

Labels and instructions in English and Spanish; Other information can be provided in English.

6. Other matters

The following medical devices are not required to be registered or enrolled:

① Customized medical devices for human use can be manufactured that do not require a health record;

② Medical devices for human use used for research purposes conducted in a scientific environment, but not intended for commercialization;

③ Attachments or components of medical devices for human use, which shall be listed in the health registry of the human-use medical device in which they were manufactured;

④ Components or spare parts of medical devices;

⑤ Single-use devices, so long as it is not intended to be sold separately, it should be included in the health registry of single-use devices.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

Registration Cycle

Registration usually takes two to six months.

Official Fee

New product registration fee: $905.

License change fee: $95.

License renewal fee: $185.

Chapter 3 FAQ

Q: What are the requirements for the registration of medical devices in Ecuador?

A: Enterprises need to ensure that products comply with ISO 13485 quality management system requirements, EMC and safety testing standards. In addition, some high-risk medical devices also need to undergo clinical trials or registration approval.

Q: How long does it take to get a notarization of Ecuador the Hague Certification?

A: According to Wiselink's project experience, the overall certification process takes 1-2 weeks.

Q: How long is the medical device registration certificate in Ecuador valid?

A: Five years.

Q: Is CE certificate mandatory for medical device registration in Ecuador?

A: The CE certificate is not mandatory.