El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices

 
• By Francesca Bruce
  
Generate a summary of this article
Listen to this article
Beta

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

El Salvador flag pinned to map.
El Salvador Strengthens Regulatory environment for medicines • Source: Shutterstock

El Salvador is to create the Superintendency for Health Regulation (SHR), a new regulatory body that will authorize medicines and medical devices, grant export and import licenses and set medicine prices. The move is expected to strengthen the national health system and protect patients, as well as make El Salvador a more competitive pharmaceutical market.

Earlier this month, the country’s legislative assembly passed the Health Regulation Superintendency bill, which will establish the new entity. The...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

SpotifyApple PodcastsWebsite

More from Latin America

El Salvador Sets Up New Regulatory Body To Oversee Medicines & Devices

 
• By Francesca Bruce

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

News We’re Watching: Quidel Recall, Partnerships For Teladoc And Lifebit, Alaris Cybersecurity Issues

 
• By Elizabeth Orr, Brian Bossetta, and Marion Webb

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.

News We’re Watching: New CDC Director, Endologix Study Success, Hospital Closure Linked To Ransomware

 
• By Elizabeth Orr

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.

FDA Investigating Disposable Gloves From Hundreds Of Foreign Companies Because Of Reprocessing Fears

 
• By Shawn M. Schmitt

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.

More from Geography

Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances

 
• By Brian Bossetta

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

Biocomposites Fully Acquires SYNICEM And Subiton Lines, Launches NanoBone In UK

 
• By Natasha Barrow

UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.

Senseonics Readies For US Launch Of 'World’s First One-Year CGM'

 
• By Natasha Barrow

US FDA has greenlighted Senseonics’ Eversense 365 continuous glucose monitor, which must be replaced just once a year. Capable of being integrated with compatible insulin pumps as part of an automated insulin delivery system, the fully implantable device lasts 185 days longer than the Eversense E3 sensor and far outstrips competing CGMs, which last only for 10-14 days.