Registration holder for Medical Devices Imported from Mexico.
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.
On March 31, 2022, Mexico’s Health Authority COFEPRIS introduced a pilot program that will allow the pharmaceutical and medical device sectors to ask for regulatory guidance in a technical session concerning a variety of topics and will be held by COFEPRIS experts.
MEXICO’S COFEPRIS ANNOUNCES THAT THE INTERNAL AFFAIRS OFFICE WILL BEGIN OPERATION TO COMBAT CORRUPTION
On February 27, 2022, Cofepris, Mexico Health Authority, announced that the internal affairs office will start is operations in combating corruption.
On October 30 2020, Mexico’s COFEPRIS, modifies NOM-220-SSA1-2016, Installation and operation of the Pharmacovigilance.
Latin America is becoming a land of opportunity for many emerging markets and Food Supplements are rapidly becoming more popular in the LATAM region.This blog will overview Brazil, Mexico and Argentina Market potential for food supplements and relevant regulation specific to each region.
GRP Blog breaks down frequently asked regulatory questions pertaining to biologic registration in Mexico with Health Authority COFEPRIS
From September,1st 2020 COFEPRIS establishes the request for appointments will be via the internet and face-to-face attention in the CIS for the entry of priority formalities.
COFEPRIS establishes operating rules to promote the production of generic drugs in Mexico, by eliminating criteria that limited their production and their availability at more accessible prices for the population.
EMA announces GMP inspection fees will be waived fully for sites that undergo remote inspections during COVID-19 pandemic.