Preamble

The purpose of this guideline is to guide the registration applicant to prepare and write the registration declaration of ventilator, and also provide reference for the technical review department to review the registration declaration.

This guideline is a general requirement for ventilators, the applicant should determine whether the content is applicable according to the specific characteristics of the product, if not, need to specify the reasons and the corresponding scientific basis, and according to the specific characteristics of the product to enrich and refine the content of the registration information.

Scope of application

This guideline applies to ventilators, according to the "Medical Device Classification Catalog", the management category is Class III, classification code 08-01-01 therapeutic ventilators, 08-01-02 emergency and transfer ventilators, 08-01-03 high-frequency ventilators, 08-01-04 home ventilators (life support).

Keypoints for Registration Review

Product Name

According to "Classification Catalog of Medical Devices" and "Naming Rules for Common Names of Medical Devices", the product name of ventilator is generally based on "Ventilator" as the core word, and it can be added according to the product classification, intended use, and use scenarios, for example: non-invasive ventilator, neonatal ventilator, emergency and transport ventilator.

Principle of registration unit division

Different varieties of ventilators are divided into different registration units. For example, therapeutic ventilators, home ventilators for ventilator-dependent patients, and emergency and transfer ventilators are divided into different registration units.

Ventilators with different technical principles are divided into different registration units. For example, a pneumatic electrically controlled ventilator is classified as a different registration unit from an electric electrically controlled ventilator, and a high-frequency jet ventilator is classified as a different registration unit from a high-frequency oscillating ventilator.

Generic passive consumables used in conjunction with a ventilator are classified as a different unit of registration from the ventilator, e.g., respiratory lines, endotracheal tubes, face masks.

Active medical devices or equipment such as humidifiers, air compressors, etc. are, in principle, classified as different registration units from ventilators.

The same technical principles, product design and structure of the different safety and effectiveness of the ventilator has an impact on the principle of division into different registration units, such as airway design differences in the ventilator.

For the products with multiple models and specifications, the differences between the models and specifications should be clarified in accordance with the requirements of the above product descriptions. Adopt comparison tables and pictures and charts with explanatory text to describe the structural composition (or configuration), functions, product features and operation modes, and performance indexes of all the models and specifications to be declared.

Specify the medical stage, environment of use, and target users to which the respirator is applicable, as well as the skills/knowledge/training that should be possessed to operate or use the product.

For example, the ventilator of 08-01-01 is expected to be used in a critical care setting within a specialized healthcare facility or for patient transport within a specialized healthcare facility, is expected to be operated by trained and authorized medical personnel, is applied to patients dependent on mechanical ventilation, and is classified as a life support device. It should also specify the environmental conditions (temperature, humidity, altitude, etc.) to which the device is applicable, and information on the target patient population (e.g., adults, children, infants, or neonates). If applicable, it should also specify the weight status or ventilation of the applicable patients (e.g. children weighing less than 30 kg).

Emergency and transport ventilators are generally used in the out-of-hospital emergency and transport setting. Home ventilators may be used in the home care setting.

Home ventilators can generally be operated by inexperienced operators and the skills/knowledge/training that should be required to operate or use the product should be specified.

Ventilators that can be used in the magnetic resonance environment specify the conditions of the magnetic resonance environment. Ventilators that cannot be used in the magnetic resonance environment need not be reflected in the certificate of registration.