T/SCJDGLXH 0002-2024 Electric Nasal Irrigator

Scope

Main technical content: Nasal irrigation is one of the routine treatments for rhinitis and sinusitis. Numerous clinical studies at home and abroad have recommended nasal irrigation as the first-choice treatment for patients with acute and chronic rhinitis, and it has been included in the disease treatment guidelines of major countries and regions such as China, Europe, and the United States. According to epidemiological data, there are 1.0 billion patients with persistent rhinitis and allergic rhinitis worldwide, and about 400 million people in China. In China, the number of patients has increased by nearly 100 million in the past six years. Electric nasal irrigators, as one of the effective solutions for nasal irrigation patients to receive convenient treatment in clinical and home environments, have become widely used medical devices. Based on this, the number of registration certificates and registered enterprises for electric nasal irrigation devices in China has increased year by year in the past five years, and the market scale of this product has grown rapidly. However, due to the fragility and susceptibility to infection of the nasal mucosa, there are certain clinical use risks, and adverse reaction cases have already occurred. Therefore, formulating basic safety and performance standards for such products, clarifying the performance requirements and verification methods of such products can effectively reduce the use risks, ensure product quality, protect the interests of medical personnel and patients, and at the same time, it is conducive to the daily supervision of the products and helps to improve the overall product quality in the industry.

Development Information

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