The State Food and Drug Administration of the PRC (“SFDA”) issued a notice on December 10, 2012 with respect to the classifications of 17 medical devices. This notice was the fourth one related to medical device classifications issued by SFDA in 2012.
Under the Chinese medical device regulatory system, medical devices are classified into three classes based on their risks to humans and are subject to different regulatory oversight.
- Class I covers low risk devices and requires only general controls.
- Class II covers medium risk devices that require certain specific controls.
- Class III covers high risk devices — such as implant devices and life-supporting and life-sustaining devices — that require strict controls.
According to SFDA’s latest notice, two medical devices, ultrasound tumor therapy system and skin diagnostic imaging device, are classified as Class III medical devices. Ten medical devices are classified under Class II, including pressure distribution measuring system, sweat sensor for traditional Chinese medication, medical image processing software, fluorescence imaging and graphics software, exhalation heating and filter for ventilator, medical laser fiber, cochlear implant signal converter, contrast sensitivity device with glare, fibercholedochoscopy, and diffused optical tomography with ultrasound in the diagnosis of breast conditions. Non-contact viewing devices for ophthalmic surgeries are classified as Class I.
Additionally, SFDA confirms in the notice that four products are not regulated as medical devices, namely, high-efficiency disposal device for injection needles for medical purposes, manufacturing system for one-stop irrigation solvent, air purifier for medical purposes, and mobile carts.