The Peruvian Ministry of Health, MINSA, has issued Resolution No. 734-2024-MINSA, announcing the publication of draft regulations aimed at enhancing the registration, control, and health monitoring of medical devices. This initiative aligns with Peru’s national health policies and international commitments, particularly those connected to World Trade Organization standards.

The draft regulation is now available on the Ministry’s website for a 90-day public consultation period. During this time, citizens, public institutions, and private organizations are invited to review the draft and provide feedback via email until the 24th of January 2025. The Directorate of Medicines, Supplies, and Drugs (DIGEMID) will oversee the feedback collection and work on finalizing the regulations based on these contributions.

This public consultation marks an essential step toward enhancing the safety, quality, and accessibility of medical devices in Peru, reinforcing the Ministry’s commitment to public health and international standards.

The full Draft Regulation can be found at: Resolución Ministerial N° 734-2024-MINSA (Parte 1), Resolución Ministerial N° 734-2024-MINSA (Parte 2)

On October 25, 2024, the Ministry of Health (MINSA) of Peru issued Ministerial Resolution No. 733-2024/MINSA, introducing crucial updates to Annexes I, II, and III of the "Regulation on Permissible Exposure Limits for Chemical Agents in the Work Environment," initially established by Supreme Decree No. 015-2005-SA. The existing regulation (D.S. No. 015-2005-SA) outlines acceptable exposure limits to chemical agents in workplaces across Peru, ensuring workers are not exposed to harmful levels of hazardous or carcinogenic chemicals. The recent updates are in response to scientific and technological advancements and aim to enhance protections based on the latest health and safety research.

The updated annexes classify permissible exposure limits for various chemical agents to which workers may be exposed, prioritizing quantitative evaluation and control measures, especially for substances primarily absorbed through inhalation. The revisions include newly identified hazardous substances, refined exposure limits, and updated toxicity thresholds, aligning them with global standards.

The new permissible exposure limits will apply to all work environments where chemical or carcinogenic agents pose potential health and safety risks. This update obligates employers to adopt stricter control measures, implement adequate personal protective equipment (PPE), and ensure continuous monitoring of hazardous substances.

The full details of the Ministerial Resolution are available at: Resolution No. 733-2024/MINSA