The NMPA issued the “List of Ventilator Products Approved by Drug Administration” on January 5, 2023.
Ventilators are usually divided into invasive and non-invasive ventilators. NMPA describes that: “Invasive ventilators are Class III medical devices with high risks and require special measures to strictly control and manage them to ensure their safety and effectiveness. Non-invasive ventilators are classified as Class II medical devices which are intended for patients with spontaneous breathing and are not used for life support.
Ventilators can be used for cardiopulmonary resuscitation, respiratory failure first aid, ventilation assistance, respiratory support, etc., and are the intensive care treatment equipment for Covid-19 Infection.”
NMPA has granted 176 ventilator approvals, including 69 from overseas manufacturers which account for about 40%.
Full Ventilator NMPA List
The 69 imported ventilators are from manufacturers including but not limited to the following. One producer may have multiple approvals.
- MAQUET CRITICAL CARE AB
- Covidien llc
- Hamilton Medical AG
- Respironics,Inc.
- ResMed Limited
- Datex-Ohmeda, Inc.
- Vyaire Medical, Inc.
- CARL REINER GmbH
- Thornhill Research Inc.
- ACUTRONIC Medical Systems AG
- SLE Limited
- Draegerwerk AG & Co. KGaA
- ACUTRONIC Medical Systems AG
- Löwenstein Medical SE ＆ Co.KG
- Heyer Medical AG
- Breas Medical AB
- Flight Medical Innovations Ltd.
- eVent Medical,Ltd
- Air Liquide Medical Systems S.A.
- … …
Feel free to contact us at info@chinameddevice.com for any additional questions about this list of ventilator manufacturers.