Podcast: Q&A session on regulatory requirements for medical devices and IVDs in Ecuador
Cristina Murgueitio, Executive Director of ASEDIM – Ecuador’s medical device association – answers the following questions posed by JMDR subscribers in our new FREE podcast:
- Is Ecuador’s medical device legislation in accordance with the laws of, for example, the USA or European Union? In particular, does Ecuador use the same definition of a medical device and accessory as any of the major markets?
- What are the classification rules? Do all product classes need to be registered with the Authority?
- Are some medical devices still considered to be pharmaceutical products in Ecuador? Is it possible to do anything to change the registration category of those medical devices?
- Is a local partner necessary to obtain medical device licences/certificates?
- Are other approvals such as the CE mark or US 510(k) or Canadian MDL helpful for speeding up the registration process in Ecuador?
- What are the official evaluation timeframes stated in the regulations and are these timeframes generally adhered to? If they are not, what would you suggest is a more accurate reflection of the evaluation timeframes?
- Have you noticed an acceleration of the registration processes for medical devices deemed critical in dealing with the COVID-19 pandemic, or have there actually been delays to the processes because of COVID-19?
- How much does it cost to register/re-register a medical device in Ecuador?
- What do you consider to be the best points/advantages of the current regulatory system and what areas do you think could benefit from improvement?
- Do you think in the future there may be a single entity in LATAM for registering medical products, so a single registration could be submitted to a single entity and the resulting registration certificate would be valid in all LATAM countries?
