Tag Archives: Cofepris

Mexico seeks entry into pharma practices agreement

PharmaMexico’s pharmaceutical industry has been performing well in recent years.  Both multinational subsidiaries and domestic manufacturers are targeting booming maladies like obesity and diabetes, and taking advantage of the relatively low cost of clinical testing and R&D.  But as private sector manufacturers make headlines investing in flashy new laboratories, The Mexican government has been quietly pursuing a regulatory initiative that may soon make an important impact on pharmaceutical manufacturing in the country. Continue reading Mexico seeks entry into pharma practices agreement

Regulatory Cooperation Council to support U.S.-Mexico trade

HLRCC
Regulatory official

So this morning we were reading through the work plan for the High Level Regulatory Cooperation Council between Mexico and the United States (HLRCC).  We figure you’ve probably already read it too, but just in case you were tied up in a meeting or something, here are a few comments on the Council and its work plan.

As we’ve mentioned before, the Mexican government has been on something of a regulatory-upgrade roll during this administration.  We noted a package of regulatory reforms aimed at facilitating new business startups, the drive to take Customs processing online and a raft of green policy initiatives as some recent examples.  The HLRCC, charged with improving the compatibility, efficiency, transparency and effectiveness of government regulations across the two countries, was announced jointly by Presidents Barack Obama and Felipe Calderón on May 19, 2010.  Both countries held consultations with stakeholders during 2011 to gather input from industry and the public, and the work plan, released February 28, 2012, provides an outline of the objectives and timelines of the Council’s activities for the coming two years. Continue reading Regulatory Cooperation Council to support U.S.-Mexico trade

Mexico announces streamlined import regulations for medical devices

remote controlled radionuclide applicator system
Remote controlled radionuclide applicator system

We’re really pleased about where some Mexican government agencies are heading with their regulatory improvements.  Since time immemorial, industry associations and analysts have intoned about the cost to the economy of excessive regulatory red tape.  This can be particularly vexing for inexperienced exporters to Mexico who may be unfamiliar with some of the more arcane requirements for the importation and sale of their products in the country.  We touched on one such confusing regulatory situation recently here.  In any case, on July 13, 2011 authorities announced welcome modifications to import requirements for certain medical and health care products.

Currently, a wide range of products are classified by the Mexican government as “medical devices,” and as such they are required to be registered with the Federal Commission for Protection against Sanitary Risk (Cofepris) before they may be imported for resale.  This has meant that a gauze sponge was subject to the same detailed requirements as, for example, a remote controlled radionuclide applicator system.  Under the new system, 1,700 products will no longer be classified as “medical devices” and therefore will no longer require the registro sanitario or sanitary registration with Cofepris.

But wait, as they say, there’s more: Continue reading Mexico announces streamlined import regulations for medical devices