;   Medical Translation Insight: Mexico recognizes devices, IVDs cleared by FDA, Health Canada - ForeignExchange Translations

Mexico recognizes devices, IVDs cleared by FDA, Health CanadaThe Mexican Health Authority's Federal Commission for Protection against Sanitary Risks (COFEPRIS) has put into effect new rules recognizing medical device authorizations for Class I, II and III commercialized products in the U.S., as well as for Class II, III and IV commercialized products in Canada.

A recent article from Emergo Group explains the specifics of the new rule that COFEPRIS has made available, but many details remain forthcoming. The registration process for devices covered under the agreement will take 30 days, says COFEPRIS. The agreement will speed patient access in Mexico to the latest medtech products, it says, adding that it has been working on a new IT platform for the past year. COFEPRIS believes that domestic manufacturers will also benefit from the agreement as it will be able to dedicate more staff to deal with local procedures.

Great news for medical device and IVD manufacturers - and for Spanish medical translators!

For more details, take a look at the reform document [PDF link].


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