CFDA collaborates with the US Department of Health and Human Services on medical device regulation. Link to Memoranda of Understanding here.
Clinical Trial Data Requirements
Clinical trial requirements for medical devices are outlined in "Provisions for Clinical Trials of Medical Devices." Clinical trials of medical devices is categorized as clinical testing and clinical verification. Clinical testing is the verification of basic structure, performance, operating safety during clinical application, and effectiveness. This is for medical devices that have not yet been available on the market, and have undetermined safety and effectiveness profiles. Clinical verification is identical to clinical testing, but pertains to the verification of products that are already on the market. The extent of clinical verification is dependent on the kinds of similar products that have already been on the market, and the nature its safety and effectiveness profiles would have to be verified.
There are three classes of medical devices. Class I is of lowest risk, and Class III is of highest risk (examples include implant and life-sustaining devices). Clinical trials must be conducted for some Class II and all Class II medical devices. On March 7, 2014, the CFDA published "Administrative Regulation on the Supervision and Administration of Medical Devices," which became effective June 1, 2014. The new regulations introduce numerous changes aimed at increasing efficiency of medical device clinical testing and registration. These changes include different filing procedures, longer term of registration that can be extended through renewal, and removal of clinical trial requirements for low-risk medical devices. A summary of changes is available here. The new regulation (in English) is currently unavailable.
Clinical Trial Timelines
According to the Emergo Group, the review process takes approximately 12 months for Class 1 devices, 10-12 months for Class 2 devices, and 12-18 months for Class 3 devices.
Clinical Trial Import Authorization
Registration of imported medical devices must be submitted in both Chinese and English. Requirements are outlined here.
Clinical Trial Costs
Class 1: No official fees
Class 2: Testing fee ~$8,000
Class 3: Testing fees from $5,000 to $15,000
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
60 clinical trials approved from July 2012 to July 2014.
Product Registration Data Requirements
Medical device registration requirements are listed here.
Product Registration Process for Products Approved by SRA/WHO
If the foreign country's domestic RA has given approval, there is no need to additional clinical trials in China. Documentation needs to be provided and translated into Chinese
Post Registration Labeling Requirements
Labelling requirements are outlined in Chapter 12 of CFDA Order No. 28 ("Drug Registration Specifications and Insert Sheet"). This is available here.
Post Registration Pharmacovigilance Requirements
China is revising its medical device registration and is going to adopt stricter rules in regard to adverse events monitoring.
Product Registration Timelines
According to Emergo Group, registration can take 18 months for class 2 devices and 36 months for class 3 devices.
September 24, 2014.