The in vitro diagnostics (IVD) market in China is growing very quickly.
In China, the China Food and Drug Administration (CFDA) is the main agency that oversees drugs, medical devices, and IVDs. However, there is currently no formal IVD consultation process in China. The majority of IVD products are regulated as medical devices in an independent sub-category, while only a few IVDs are regulated as a drug.
In October 2014, new regulations were released, in which imported IVDs were required to undergo new CFDA requirements.
IVD Product Registration in China
The IVD registration process and review timeline follows the same requirements as for medical device products. Under the 2014 regulations, a Class I IVD only requires filing a notification application with the CFDA and no longer requires registration. Class II and III IVD registration processes follow those of Class II and III medical devices. However, almost all Class II and III IVD products require local clinical studies.
For imported Class II and III IVDs with no local clinical trials, the registration timeframe includes the following steps before the registration application is submitted:
- Preparing and shipping documents and samples: requires around 2 months
- Sample testing at a CFDA certified testing center in China: requires around 4 months
- Conducting clinical trials in a CFDA certified clinical center in China: time required depends on the clinical trial protocol (CTP)
- Collecting technical files, legal documents, sample testing report, and clinical data to submit with the application to the CFDA: requires around 2 months
After the registration application is submitted, the remaining steps include:
- Submitting the registration application to the CFDA: requires 5 working days
- Preliminary review by the Acceptance Office of the CFDA: requires 3 working days
- Technical review by the Center for Medical Device Evaluation (CMDE): requires 60-90 working days
- Supplement dossier preparation: requires a maximum of 1 year
- Further technical review by the CMDE: requires 60 working days for Class II IVDs, 90 working days for Class III IVDs
- If the supplementary documents are not sufficient, a supplement notice will be issued to the applicant and another technical review must be done
- CFDA final review and granting of registration approval: requires about 30 working days
China IVD Type Testing Process
Type testing requirements for imported IVDs follow the same requirements as for medical devices. The CFDA testing centers for IVD type testing will follow the specifications and testing methods set in the Product Technical Specification File, which is drafted by the foreign company. Only performance and safety specifications on the finished product need to be included in the Product Technical Specification.
Clinical Trials for IVD Products in China
Generally, for Class II and III IVDs, foreign data and samples do not exempt foreign companies from having to conduct local clinical trials in China.
According to CFDA regulations, IVD clinical trials must be conducted on the clinical samples collected from patients or healthy subjects. This study should compare the method with an accepted “gold standard.” For new methods or new IVDs, if there is no other similar IVD product, recognized clinical diagnosis criteria (like a CT or MRI) can be used as the “gold standard.” The objective of the IVD study is to evaluate the accuracy (including the sensitivity and specificity) of the new IVD product compared with the selected comparison method.
Class III IVD clinical trials require a minimum sample size of 1,000, including positive and negative samples. Trials must be multi-entry studies with at least 3 clinical sites.
For an IVD registration trial, clinical trial protocol is not required, but the study protocol must be reviewed by the Ethical Committee (EC) of the clinical sites or hospitals. The hospital’s EC will issue an EC approval letter or an EC exemption letter after the review. This letter must be submitted as part of the clinical data after the clinical trial is completed and the company files the product registration application to the CFDA.