Latin America

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.

This week, North Carolina health secretary Mandy Cohen was named the new head of the CDC; Congress debated PAHPA reauthorization; Cala Health launched a Parkinson’s Disease wearable; and IHealth.io was fined for consumer privacy violations.

The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.

Here’s the complete list of foreign firms that were included on an import alert because gloves they made or sold may have been “reprocessed, cleaned, or recycled and sold as new,” the US FDA says.

The Association for the Advancement of Medical Instrumentation is launching a slate of educational programs for medtech regulatory and quality assurance professionals in the Latin American country.

Mexico’s health care agency is suing Zimmer Biomet for a refund on purchases it made from the company during a long-running bribery scheme. The agency claims the bribery, which was admitted in a 2017 settlement with the US government, nullified its contracts with the device maker.

The new US-Mexico-Canada (USMCA) free-trade agreement aims to make it easier for the three countries to align on inspecting medical device manufacturing facilities by using the Medical Device Single Audit Program (MDSAP). Former US FDA official Kim Trautman explains how Mexico – which currently doesn’t accept the results of MDSAP audits – can come up-to-speed with the program.

The US-Mexico-Canada (USMCA) treaty calls for the three countries to “recognize audits” performed under the Medical Device Single Audit Program. MDSAP is already used by device makers in the US and Canada so they can undergo one audit by an accredited third party to satisfy quality regulations. That leaves Mexico as the odd country out when it comes to using the popular program – and that means it has some catching up to do after the USMCA is ratified by all three nations. Former longtime FDA official Kim Trautman weighs in on how Mexico can incorporate MDSAP into its regulatory framework.

The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.

Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.

The new US-Mexico-Canada (USMCA) trade agreement includes language on enhancing regulatory compatibility between the three countries by recognizing quality systems audits performed under the Medical Device Single Audit Program (MDSAP). It also stipulates that each trading partner “consider its resources and technical capacity” in ensuring the safety, effectiveness and quality of devices – and more. Medtech industry advocacy group AdvaMed is praising the deal, reached by the three countries on 10 December.

Republican leaders in the US Senate and House, along with the device industry, are pushing for swift approval by Congress of the US-Mexico-Canada trade agreement (USMCA), which benefits industry through more than $12bn in trade with Mexico each year.

New Mexican president Andrés Manuel López Obrador, a member of the National Regeneration Movement (MORENA) party, has swept the office on an anticorruption platform. Some observers expect his efforts to include reforms and increased regulation touching the medical device sector. Nicholas Berg, an attorney with Ropes & Gray, said that in the past Mexico has made limited efforts to combat public corruption. See his advice for medtech companies planning on doing business in Mexico here.

Recently inaugurated Mexican President Andrés Manuel López Obrador campaigned on a promise to tackle the country’s corruption issues. Medtech Insight spoke to attorney Nicholas Berg, of Ropes & Gray, about what this may mean for device manufacturers doing business in Mexico.

The International Medical Devices Database from the International Consortium of Investigative Journalists – an output of ICIJ's recent string of "Implant Files" stories that were critical of industry – offers information on more than 700,000 device recalls, field safety notices and safety alerts documented in 11 countries. While device-makers and shrewd consumers will discover a bevy of useful data in the public repository, it could prove confusing for laypeople. A recalls expert and an ex-FDA official weigh in.

Under a US-Mexico-Canada trade accord agreed to by the Trump administration Oct. 1, the three countries would harmonize medical device regulations, accept the Medical Device Single Audit Program (MDSAP) and grant marketing authorizations across international boundaries. The deal still needs sign off by the US Congress and the Mexican and Canadian governments.

A recent guidance document from Mexican medical device regulator COFEPRIS simplifies the agency’s recommendations for online promotion of medical devices.

The latest version of the Mexico Pharmacopea includes new regulations for several device types, which appear to impose stricter regulations for diagnostics and some types of medical device software.

The September hurricane destroyed Puerto Rican medical device plants, causing a shortage of several key products that's still being felt. FDA Commissioner Scott Gottlieb said Monday that the agency is allowing more imports and considering other tactics to ease the shortage.