The Department of General Affairs of the National Medical Products Administration ("NMPA") has recently distributed the Circular on Severely Cracking down on Illegal Production and Sale of Novel Coronavirus Test Reagents (the "Circular").
The Circular reads that: 1. Supervisory checks will be intensified among enterprises engaged in production and distribution of relevant diagnostic reagents, third-party platforms rendering services for online transactions of medical devices, and online distributors. 2. Parties that engage in production or distribution without authorization or produce or distribute unregistered or unapproved test reagent products, will be investigated and punished more severely as quickly as possible in accordance with law. Operators of third-party online platforms where medical devices are offered will be admonished through regulatory talks and ordered to make rectifications within the prescribed time limit, if they fail to perform their duty of registering on the books and checking the business operators doing business on their respective platform, or fail to timely deal with relevant false information on their platform. 3. Drug regulators shall strengthen coordination and cooperation with public security organs, cybersecurity regulators and telecoms regulators, notify cybersecurity regulators and telecoms regulators in a timely manner of websites and applications (Apps) involved in the release of false information or the production or distribution of illegal novel coronavirus test reagents, and in the case of any crimes, promptly refer the cases to public security organs in accordance with the law.