Chinese Regulators Expand List of Medical Devices Exempt from Clinical Trial Requirements
The China Food and Drug Administration (CFDA) has issued two new draft lists of medical devices to exempt from clinical trial requirements.
The regulator is seeking comments (link in Chinese) on additional Class II moderate-risk and Class III high-risk devices that would not need to undergo clinical trials in China prior to registration for sale in the country. The lists identify 259 Class II and 93 Class III devices that would qualify for clinical trial exemption.
Class II devices identified by the CFDA for exemption include preoperative skin preparations, neurosurgical equipment such as clamps and cutters, hemostatic gauze and bone surgery equipment.
Among Class III devices included in the list are disposable and single-use syringes with needles, disposable insulin pen needles, ultrasound imaging equipment, planing power systems and implant sealants.
The CFDA is accepting comments on these proposed exemptions through June 20, 2016. If these exemptions go through, many device manufacturers will not have to meet significant clinical trial requirements in order to obtain Chinese market registration.