Chinese Medical Device Classification

Rules for Classification of Medical …

http://english.nmpa.gov.cn/2019-10/11/c_415411.htm

Article 9 The China Food and Drug Administration may organize a medical device classification experts committee to formulate and adjust the medical device classification catalogue. …

Overview of Medical Device Regulation in China - Morgan Lewis

https://www.morganlewis.com/pubs/2020/02/overview-of-medical-device-regulation-in-china

NMPA Classification Specifications

https://chinameddevice.com/services/regulatory-services/ra-strategy/nmpa-classification/

In China, all medical devices are divided into three classes by their risk levels: Class I. Low-risk medical devices whose safety and effectiveness are ensured through routine administration. Class II. …

China Medical Device Regulatory Database …

http://cirs-md.com/resources/cmdrd

CMDRD provides a simple, easy-to-use interface for quick access to medical device classification, regulation, standard and other important information. Medical Devices Classification Search …

About China Medical Device Classification - China Med …

https://chinameddevice.com/about-china-medical-device-classification/

January 7, 2020. China’s current NMPA medical device classification system has been in place since August 1, 2018, which specifies that “classifications should be …

The Catalog of Chinese Medical Device Classification | Zhixie Info

http://www.nmpa-classification.com/

The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). …

China Medical Device Regulations – An …

https://chinameddevice.com/medical-device-regulations-in-china/

In addition, all included product information, packaging, and labels, etc. need to be translated into simplified Chinese. For a Class I devices, you just need to do simple product filing to NMPA. …

China Medical Device Registration

https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/china/

The first step in registering your medical device in China is to classify your product in China. China classifications range from Classes 1-3. However, just because your product is registered as a Class 2 …

Medical Device Classification in China - 4 …

https://chinameddevice.com/medical-device-classification-in-china-4-things-you-must-know/

There are 4 areas with significant updates to regulations. I. Clinical Trials. Again, Class I devices and most Class II devices do not require clinical trials. Class III devices are only …

China NMPA Regulatory Approval Process for …

https://www.emergobyul.com/resources/china-nmpa-regulatory-approval-process-medical-devices

Compile application dossier. Step 6. For Class II and III devices: Send devices to China for testing to be carried out by an NMPA-authorized test center. Prepare China Clinical Evaluation.***. Data from clinical …