Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Mexican Ministry of Health Advances with SaMD
The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).
Registration holder for Medical Devices Imported from Mexico
Registration holder for Medical Devices Imported from Mexico.
Mexico’s Cofepris medical Device and IVD Registration and Approval in Mexico
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
Mexico’s Cofepris has Issued New Guidelines for Changes to Medical Device Registrations
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
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.
Mexico’s COFEPIRS Pilot program on Technical Sessions
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.
Mexico’s Cofepris Submits preliminary draft amendment of the Health Products Regulation
On April 7th, Cofepris submitted a preliminary draft amendment on Heath products regulation with the goal to optimize current practices based on best practices of international regulatory agencies.
Mexico’s Cofepris Modifies Pharmacovigilance Regulation: NOM 220-SSA1-2016
On October 30 2020, Mexico’s COFEPRIS, modifies NOM-220-SSA1-2016, Installation and operation of the Pharmacovigilance.
Food Supplements in Latin America : Market overview and Regulations
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.
Registration of Biologics in Mexico : Frequently asked Questions
GRP Blog breaks down frequently asked regulatory questions pertaining to biologic registration in Mexico with Health Authority COFEPRIS