Compliance Guide for Nebulizers in European and American

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Update time : 2025-12-18

Against the backdrop of the rising global incidence of respiratory diseases and growing demand for home medical care, nebULizers, as critical devices for treating respiratory disorders, are witnessing steady growth in the global market. The regulatory frameworks in Europe and America are renowned for their stringency. Enterprises must systematically understand core aspects such as product classification and applicable standards. This document systematically sorts out market access requirements, helping enterprises accurately seize overseas market opportunities.

Common Types of Nebulizers

A nebulizer is a type of medical device that physically converts medications into aerosol particles for easier absorption by the human body, and is commonly used in the treatment of respiratory diseases.

Based on their working principles, nebulizers can be roughly categorized into three types: ultrasonic nebulizers, compressed nebulizers, and mesh nebulizers.

Comparison of the Three Nebulizer Types

Nebulizer Type	Advantages	Disadvantages
Ultrasonic Nebulizer	Large aerosol output, conducive to mucosal absorption of medications; low noise; fast nebulization speed, resulting in shorter nebulization treatment duration.	High mechanical impact on patients due to fast nebulization speed; large particle size of aerosol, which mostly deposits in the upper respiratory tract; not suitable for nebulizing suspension medications; suboptimal drug absorption effect.
Compressed Nebulizer	Simple operation; thorough nebulization of liquid medications; high distribution of aerosol particles within the 2-5μm range, facilitating absorption in the respiratory tract.	High noise; long nebulization time; inconvenient for pediatric patients to use; poor portability.
Mesh Nebulizer	Low residual volume of nebulized liquid, enabling full utilization of medications; minimal impact on drug properties during nebulization; compact size, easy to carry, and no noise; convenient operation and short nebulization time.	High requirements for product structural design, especially the material selection and design of mesh pore size; mesh pores are prone to clogging during nebulization, limiting the number of uses; high usage cost.

Applicable Standards and Guidelines for Products

Project Category	Standard Number	Reference Guide / Standard Name
Electrical Safety	iec 60601-1: 2005+A1: 2012+A2: 2020	Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
	IEC 60601-1-11: 2015+A1: 2020	Medical Electrical Equipment - Part 1-11: Collateral Standard to General Requirements for Basic Safety and Essential Performance: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (if applicable)
EMC	IEC 60601-1-2: 2014+A1: 2020	Medical Electrical Equipment - Part 1-2: Parallel Standard to General Requirements for Basic Safety and Essential Performance: Electromagnetic Compatibility - Requirements and Tests
	IEC TS 60601-4-2: 2024	Medical Electrical Equipment - Part 4-2: Guidance and Explanation - Electromagnetic Compatibility Immunity: Performance of Medical Electrical Equipment and Medical Electrical Systems
Performance	ISO 27427: 2023	Anaesthetic and Respiratory Equipment - Nebulizing Systems and Components
biocompatibility of Breathing Gas Tubing	ISO 18562-1: 2024	Evaluation of the Biocompatibility of Breathing Gas Pathways in Medical Applications - Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
	ISO 18562-2: 2024	Evaluation of the Biocompatibility of Breathing Gas Pathways in Medical Applications - Biological Evaluation of Medical Devices - Part 2: Particulate Matter Emission Tests
	ISO 18562-3: 2024	Evaluation of the Biocompatibility of Breathing Gas Pathways in Medical Applications - Biological Evaluation of Medical Devices - Part 3: Volatile Organic Compound (VOC) Emission Tests
	ISO 18562-4: 2024	Evaluation of the Biocompatibility of Breathing Gas Pathways in Medical Applications - Biological Evaluation of Medical Devices - Part 4: Leachables Tests in Condensate
Biological Evaluation	ISO 10993 Series Standards	Selected based on actual project requirements
Particle Characteristics	-	FDA Nebulizer Guidance, United States Pharmacopeia
Cleaning and Disinfection	-	FDA Medical Device Reprocessing Guidance and Relevant Standards
Technical Documentation	IEC 62304: 2006+A1: 2015	Medical Device Software - Software Life Cycle Processes (if applicable)
	ISO 14971: 2019	Medical Devices - Application of Risk Management to Medical Devices
	ISO/TR 24971: 2020	Medical Devices - Guidance on the Application of ISO 14971
	IEC 62366-1: 2020	Medical Devices - Part 1: Application of Usability Engineering to Medical Devices
	IEC 60601-1-6: 2020	Medical Electrical Equipment - Part 1-6: Parallel Standard to General Requirements for Basic Safety and Essential Performance: Usability

JJR LAB Service Solutions

As one of the few laboratories in the market authorized with CNAS/CMA qualifications for all nebulizer product testing standards, JJR LAB provides manufacturers with one-stop registration and testing service solutions for global market access of nebulizers:

Performance Verification Solutions

In accordance with the performance evaluation requirements of CE MDR and FDA for such products, JJR LAB formulates comprehensive performance evaluation solutions, including:

①　Research on nebulization stability of products under different medication conditions

②　Tests under scenarios of usage by different populations, at different angles, with different gears, and in combination with different accessories

③　Cleaning, disinfection, and sterilization verification

④　Shelf-life performance verification

⑤　Research on performance stability under simulated transportation conditions

The technical team comprehensively applies the United States Pharmacopeia from multiple perspectives and adopts the cascade impaction method (ISO 27427: 2023) to conduct product performance research on core technical parameters such as nebulization rate, mass median aerodynaMIC diameter (MMAD), and particle diameter. Our scientifically designed and standardized verification solutions cover the entire product life cycle, helping enterprises address key pain points, gain recognition from FDA review authorities more easily, and shorten the review cycle by approximately 30%.

Compliance Guide for Nebulizers in European and American(图1)

Biological Evaluation Solutions

Based on product structure, optional accessories, and material characteristics, JJR LAB customizes testing solutions to ensure full compliance with regulatory requirements of target markets. Meanwhile, in accordance with relevant FDA 510(k) requirements, equivalence demonstration is adopted to REDuce duplicate testing, optimize costs, and help enterprises quickly complete registration and declaration for market access in Europe and America.

With over 20 years of experience in the medical device technical service industry, the company has cultivated a large number of experienced professional and technical personnel, including multiple seasoned toxicology professionals and toxicologists certified by the Chinese Society of Toxicology. We are capable of conducting toxicological evaluations on emissions and leachables from breathing gas tubing of medical devices, and providing a full set of biological evaluation reports and toxicological reports.

Currently, JJR LAB has assisted numerous medical device enterprises in completing NMPA, FDA, and CE registrations for their products, covering nebulizers, ventilators, nasal oxygen cannulas, ventilator accessories, oxygen concentrators, etc. Welcome to contact us for one-on-one professional service solutions!