Inhalers (saline steam inhalers)

Form: Portable saline steam inhalers, Nebulizers

Strength: Designed for nasal or bronchial steam therapy, typically deliver 3-10 mL/min of saline mist

Reference Brands: Vicks, NebuTech, Aeroneb, Philips Respironics

Category: OTC

Saline steam inhalers in the EU and US are regulated to ensure safety, efficacy, and quality. In the US, approval involves validation, safety testing, and GMP compliance, while in the EU, CE marking certifies conformity with MDR standards. These devices undergo validation, performance testing, and audits, supported by detailed documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to reliable, safe saline inhalation devices vital for respiratory therapy, congestion relief, and airway support in clinical, veterinary, and home care settings worldwide, promoting respiratory health and safety.