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China Update: IVD Classification Rules, Medical Device Self-testing Requirements

Chinese regulators issue new IVD classification rules based on CFDA and IMDRF efforts, plus requirements for self-testing and self-inspection for medical device registrants

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November 16, 2021

The China National Medical Products Administration (NMPA) has published new classification rules for in-vitro diagnostic (IVD) medical devices, as well as requirements for manufacturers to self-test their devices for Chinese market registration.

New IVD classification rules issued

The NMPA’s Classification Rules for In Vitro Diagnostic Reagents (link in Chinese) are based on requirements implemented by the regulator’s predecessor organization, the China Food and Drug Administration (CFDA), and reflect principles for IVD classification developed by the International Medical Device Regulators Forum, or IMDRF.

Although the new rules took effect in late October, related IVD classification catalogues will still apply until NMPA issues their revisions.

Medical device self-testing regulations

In addition, the NMPA has issued Regulations for the Management of Medical Device Registration Self-Testing (link in Chinese). These regulations cover requirements for registrants’ capacity for self-testing, as well as self-inspection and related obligations.

The NMPA regulation also includes required templates for self-testing submissions.


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