Q&A – IVD/CDx

How is IVD classified in China?

Same as FDA, NMPA categorizes IVD products into one of three classes – Class I, II, or III – based on their risk level. The IVD reagents classification catalog, “6840 In Vitro Diagnostics Reagents Classification Sub-catalog” was first published in 2013, which divides IVD reagents into 22 categories. It must be noted that, IVD reagents used for blood screening and IVD reagents labeled by radionuclide are regulated as drugs in China.

Is a clinical trial mandatory for NMPA registration of IVD reagents?

A2 IVD products including instrumentation platforms, corresponding software and IVD regent are regulated in China in accordance with the relevant regulations for medical devices. According to Decree No. 650, clinical trial is not required if class II and III devices are on the clinical trial exempt List. As of December 2020, a total of 431 IVDs are exempt from clinical trials in China, including 383 Class II IVD reagents and 48 Class III IVD reagents.

For IVD reagents on the clinical trial exempt list, the applicant can choose to perform predicate comparison study instead of clinical trial. But different from general medical device products, for predicate comparison of IVD reagents, the applicant is required to perform methodology comparison studies for the predicate and the product to be marketed under non-clinical trial settings to prove their equivalency.

What documents are required for manufacturing site change?

A3 To change the manufacturing site of imported overseas IVD reagents, besides the documents (application form, home country approval of the change, statement/description about the change etc.) needed for all permission item changes, NMPA also require the applicant to submit the following documents (CFDA Circular [2014] NO. 44):

1. The quality system assessment report of the manufacturing site change (if applicable)
2. Documents which can prove that the new manufacturing site can meet the Quality Management System requirements of the country (region) where the site is located or the documents which can prove that the new manufacturing site has passed the quality management system certification.
3. The analytical performance study data using the products produced at the new manufacturing site.
4. Updated IFU and label artwork.

NMPA (CFDA) does not indicate specific requirements on the analytical performance evaluation data, however, all verification and validation documents are used as supportive documents to demonstrate the equivalency between the products before and after the change of manufacturing site. The analytical characteristics in registered Product Technical Requirements are recommended to be tested and verified.

Please be noted that documents requirements listed above are not applicable for transferring the manufacturing site of products with Imported Medical Device Certificate to local enterprise in China.

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