CFDA issues the sencond batch medical deviceswhich clinical trail exempted for public comment - Regulatory News - Medical Devices

Dec 14^th, 2015, Center for Medical Device Evaluation.CFDA issued the exposure draft of the Second wave of catalogue of medical devices exempted from clinical trials in China. If the second wave of the catalogue is approved, clinical trial will no longer be required for 145 device types from 15 categories of Class II medical devices and 85 device types from 12 categories of Class III medical devices. What is more, the IVDs products of class II are listed in the catalogue for the first time.

The categories of Class II medical devices are as following:

No.	MD Code	Category Name
1	6804	Ophthalmic Surgical Devices
2	6810	Orthopedic Surgery (Orthopedic) Surgical Instrument
3	6821	Medical electronic equipment
4	6822	Medical Optical Equipment, Instruments And Endoscopic Equipment
5	6823	Medical Ultrasound Equipment And Related Equipment
6	6824	Medical Laser Equipment
7	6826	Physiotherapy And Rehabilitation Equipment
8	6840	In Vitro Diagnostic Reagents, Clinical examination and analysis instrumen
9	6841	Medical assay device and basic equipment
10	6845	Extracorporeal circulation and blood processing equipment
11	6854	Equipment And Appliance Used In Operating Rooms, Emergency Rooms, Clinics Room Utensils
12	6855	Equipment And Appliance For Department Of Stomatology
13	6857	Equipment and appliance for disinfection and sterilization
14	6866	Medical polymer materials and products
15	6877	Interventional Appliances

The categories of Class III medical devices are as following:

No.	MD Code	Category Name
1	6822	Medical Optical Equipment, Instruments And Endoscopic Equipment
2	6823	Medical Ultrasound Equipment And Related Equipment
3	6824	Medical Laser Equipment
4	6826	Physiotherapy And Rehabilitation Equipment
5	6845	Extracorporeal circulation and blood processing equipment
6	6846	Implant Materials And Artificial Organs
7	6854	Equipment And Appliance Used In Operating Rooms, Emergency Rooms, Clinics Room Utensils
8	6855	Equipment And Appliance For Department Of Stomatology
9	6863	Dental material
10	6864	Medical Hygienic Materials And Dressings
11	6866	Medical polymer materials and products
12	6877	Interventional Appliances

If you find your products in the catalogue, the products are expected to be exempted from clinical trials in 2016. But, it does not mean that you can submit the document without clinical evaluation data while you obtain the immunity of clinical trial. Instead, the clinical evaluation data shall be more comprehensive and sufficient.

CFDA has issued a technical guideline on medical devices clinical evaluation on may 19th, 2015, which amied to provide the reference and instruction for applicannt to conduct clinical evaluation. The guideline indicated that if your product listed in the catalogue, your product id free of clinical trial. But there is still two things need to be comfirmed:

Comparison between the information of your product and the description of corresponding device in above catalogue;
Comparison between your product and approved device in above catalogue, please see here for the comparative table.

If you want the detailed products list, you can contact us for a free.

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