*Class I and II devices covered by a certificate issued by one of reconized countries (USA, EU, Canada, Australia, Japan, South Korea) may be subject to a simplified route.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Ecuador shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have a lot of experience with medical device classification in Ecuador.
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 your device(s) is critical if you will not have a direct sales office in Ecuador. We will help you find a reliable Authorized Representative.
Technical documentation provides proof that your product is safe and effective. MDRC will prepare your technical documentation in accordance with ARCSA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Ecuador's regulations.
While your registration is being finalized, our distribution specialists can help you find and evaluate distributors. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Ecuador.
| Validity | 5 years |
| Language | Documents and Labeling must be in Spanish |
| Postmarket Surveillance | N/A |
| Expected Time | No official timelines. Usually registration takes 2-6 months |
*Class I and II devices covered by a certificate issued by one of reconized countries (USA, EU, Canada, Australia, Japan, South Korea) may be subject to a simplified route.
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Ecuador shown below.
Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have a lot of experience with medical device classification in Ecuador.
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 your device(s) is critical if you will not have a direct sales office in Ecuador. We will help you find a reliable Authorized Representative.
Technical documentation provides proof that your product is safe and effective. MDRC will prepare your technical documentation in accordance with ARCSA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with Ecuador's regulations.
While your registration is being finalized, our distribution specialists can help you find and evaluate distributors. This will increase the chances of finding a partner who is qualified and able to effectively market your products in Ecuador.
