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In order to strengthen the supervision and guidance of the registration of medical device products and further improve the quality of registration review, the State Food and Drug Administration organized a revision to return to principles this week.

Guidelines for the technical review of medical atomizer registration

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In order to strengthen the supervision and guidance of the registration of medical device products and further improve the quality of registration review, the State Food and Drug Administration organized a revision to return to principles this week.

This guideline is intended to guide registration applicants in the preparation and writing of medical atomizer registration application materials, and also to provide a reference for the technical review department to review registration application materials.

This guideline is a general requirement for medical atomizers. Applicants should determine whether the content is applicable based on the specific characteristics of the product. If not, the reasons and corresponding scientific basis must be specified, and the registration declaration should be based on the specific characteristics of the product The content of the materials is enriched and refined.

This Guiding Principle is a guidance document for applicants and reviewers. It does not involve administrative matters such as registration approval, nor is it enforced as a regulation. If other methods can meet the requirements of the regulation, it can also be used, but detailed research should be provided. Information and verification information. This guideline should be used in compliance with relevant regulations.

This guideline is formulated under the current regulations, standard systems and current cognitive level. With the continuous improvement of regulations and standard systems and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in due course.

Chinese name

Guidelines for the technical review of medical atomizer registration

Issuing authority

State Food and Drug Administration

Posting time

February 19, 2016

Issue number

Number 22, 2016

This guideline is intended to guide registration applicants in the preparation and writing of medical atomizer registration application materials, and also to provide a reference for the technical review department to review registration application materials.

This guideline is a general requirement for medical atomizers. Applicants should determine whether the content is applicable based on the specific characteristics of the product. If not, the reasons and corresponding scientific basis must be specified, and the registration declaration should be based on the specific characteristics of the product The content of the materials is enriched and refined.

This Guiding Principle is a guidance document for applicants and reviewers. It does not involve administrative matters such as registration approval, nor is it enforced as a regulation. If other methods can meet the requirements of the regulation, it can also be used, but detailed research should be provided. Information and verification information. This guideline should be used in compliance with relevant regulations.

This guideline is formulated under the current regulations, standard systems and current cognitive level. With the continuous improvement of regulations and standard systems and the continuous development of science and technology, the relevant content of this guideline will also be adjusted in due course. ^[1]

This guideline applies to the second type of medical nebulizer products (or nebulizers). The product atomizes the drug for inhalation by a patient by means of ultrasonic vibration or a gas compressor.

The medical nebulizers referred to in this guideline belong to the "Using Medical Device Classification" 6823-6 ultrasonic nebulizers, and the "Notice on the Classification and Definition of 166 Products such as Cold and Hot Dual Controlled Ablation Needles" Jianjian [2011] No. 231) The compression type atomizer specified in Article 2 (63) of the document, the management category code is 6821.

This guideline does not apply to net-type nebulizers and appliances that use external gas sources to atomize drugs (such as hospital atomic gas supply systems or other compressed oxygen or medical gas as a source of drug atomizers ), But you can use these guidelines to conduct a technical review of these products. ^[1]

(I) Product name requirements

The name of the product shall be a general name and shall comply with the requirements of relevant regulations and regulatory documents such as the "Medical Device Naming Rules", "Medical Device Classification Catalog", standards and other standards. The product name can be named according to the principle and method of atomization, such as: "medical ultrasonic atomizer" or "medical compression atomizer".

(B) the structure and composition of the product

The structure and composition of the product should first describe the main components of the product, and if necessary, the composition of the main components.

The medical ultrasonic atomizer is generally composed of a host, an atomizing cup, a mist tube, a suction nozzle or an inhalation mask. The host can be an ultrasonic generator (ultrasonic transducer), an ultrasonic film, an air supply device, and an adjustment and control system. composition. An example of a medical ultrasonic atomizer product is shown in Figure 1.

(Three) product working principle / action mechanism

1. Working principle of medical ultrasonic atomizer

Ultrasonic atomizer The high-frequency current generated by the ultrasonic generator passes the ultrasonic transducer installed in the atomizer to convert the high-frequency current into sound waves of the same frequency. The ultrasonic waves generated by the transducer pass through the atomizer. Coupling effect, through the ultrasonic film at the bottom of the atomizing cup, so that the ultrasonic wave directly acts on the liquid in the atomizing cup. When ultrasonic waves are transmitted from the bottom of the cup to the surface of the medicinal solution, the liquid-air interface is the interface between the medicinal solution surface and the air. After being subjected to the action of the ultrasonic waves perpendicular to the interface (that is, the energy effect), the medicinal solution surface forms tension With the increase of surface tension wave energy, when the surface tension wave energy reaches a certain value, the tension wave peak on the surface of the medicinal solution also increases at the same time, causing the liquid mist particles at the peak to fly out (the size of the mist particle diameter It decreases as the frequency of the ultrasound increases). Due to the uniform size and small momentum of the ultrasonic generated mist particles, it is easy to walk with the airflow. The number of mist particles generated by the medicinal solution increases with the increase of the ultrasonic energy (that is, the greater the power of the ultrasonic wave, the larger the number of mist particles generated). more). After the medical ultrasonic atomizer splits the medicinal solution into particles, the medicinal mist is generated by the air flow generated by the air supply device, and the medicinal mist is delivered to the patient through the mist delivery tube. ^[1]

(1) Whether the electrical safety performance and main technical performance of the product have complied with national and industry compulsory standards, whether the determination of performance indicators can meet the safety and effectiveness of the product, and whether the equivalent volume particle size distribution of the atomized particles is required.

The equivalent volume particle size distribution of atomized particles is a technical index that has a direct and important impact on the effectiveness of medical atomizer products. This requirement has been listed in the industry standard YY0109-2013 "Medical Ultrasonic Nebulizer", and its inspection and verification should be paid special attention during the review.

(2) The user must inform the user whether the information is complete. For example, the environment in which the product is used, the user group, and the types of drugs that are restricted in use should be specified; the precautions for the use of single-use parts of the product should be specified.

(3) Whether the main risks of the product have been listed, and the safety of the product is within a reasonably acceptable level through risk control measures.

(4) Containers and parts in contact with the medicinal solution in the product shall require the company to clearly identify the materials used, and indicate whether the material is added with a plasticizer, and if it is added, the safety shall be explained. ^[1]

I. Purpose and background of the revised guiding principles

(I) Revision background

1. With the promulgation and implementation of the newly revised "Regulations on the Supervision and Administration of Medical Devices" and its supporting regulations, as well as the revision and revision of the industry standards related to such products, according to the requirements of the State General Administration, this Guiding Principle needs to be revised.

2. The main contents of this revision:

1) The relevant technical indicators in the relevant standards and technical requirements applicable to the product have been modified in accordance with the formulation and revision of the national bank standard;

2) The amendments supplemented the requirements for cleaning and disinfection of suction nozzles, masks and their connections;

Added requirements for chemical properties of nozzles, atomizing cups, mist delivery tubes and other components that come into direct contact with the drug solution, and the material of the catheter;

3 Added product-related adverse event history: Collected and analyzed nebulizer adverse event reports retrieved from the FDA database.

Supplemented and revised the corresponding content in accordance with the newly released "Requirements for Registration of Medical Device Registration Information";

4) Adjusted the format in accordance with the "Guidelines for the Preparation and Revision of Management Guidelines for the Technical Review of Medical Device Registration";

5) Partial changes were made to the intended use of the product and the requirements of the chemical agent in the review points. ^[1]

This guideline was written by:

Liaoning Food and Drug Administration

Liaoning Provincial Drug Evaluation and Monitoring Center

Liaoning Provincial Medical Device Inspection and Testing Institute