8 docs tagged with "start-here"

Introduction to the mandatory China Agent (代理人) role for imported medical devices under MDSAR 2021.

English and Chinese regulatory terminology for China medical device regulation under NMPA.

The full regulatory lifecycle of a medical device in China — from classification through to re-registration.

Overview of China's medical device regulatory framework — NMPA, CMDE, provincial bureaux, and the three-tier authority split.

Definition of a medical device under MDSAR 2021 and how NMPA determines whether a product is a medical device.

Definition of in vitro diagnostic reagents and devices under China's regulatory framework.

Products excluded from China's medical device definition under MDSAR 2021.

Who is subject to China medical device regulation — domestic manufacturers, importers, China Agents, distributors, and hospitals.