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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:

Products still classified as medical devices but designated as “low-risk” will now be subject to a simplified sanitary registration.  The low-risk designation will include products such as diagnostic agents, hygiene products, bandages and some dental materials, according to Cofepris.

So we were about to put our remote controlled radionuclide applicator system in a box and ship it to Mexico, when we realized we still had two big questions: 1) When do the new rules go into effect, and 2) what products are in each of the new classifications?  And the answer is, it’s hard to tell.  Cofepris said the definitive list of products that will no longer require sanitary registration will be published on their web site “in August,” so hopefully when the list is posted it will indicate the date on which the regulatory change goes (or went) into effect.  For the moment, several helpful pieces of information are provided here, such as the current requirements and guidelines for obtaining a sanitary registration, classification of products by degree of sanitary risk, and a list of products that do not require sanitary registration.  For an overview of the sanitary registration process in English prepared by the U.S. commercial service, go here.

Cofepris estimates that the revised regs will save consumers approximately 240 million dollars.  We’re not sure how they came up with that number, but if they save consumers 240 million pesos we’ll consider ourselves well served, and especially relieved for the importers and exporters who can benefit from the new rules.  Cofepris also announced it has signed an agreement with the Federal Regulatory Improvement Commission (Cofemer) to collaborate and exchange information in order for Cofemer to evaluate Cofepris’s regulations and procedures with an eye toward recommending further improvements.  We promise we’ll respect federal agencies more if they keep making changes that help those of us in trade get our business done faster and more cheaply.  Well played, sirs!

To read about our participation in the Mexico Today program, go here.