In late October, the NMPA broadcasted the Rules for Applicable Discretion of Administrative Penalties in Drug Supervision and Administration for stakeholders’ feedback. The updated draft applies to medical devices, drugs, and cosmetics and outlines how the Chinese government will gather evidence of infringement and determine the final penalties. In the updated draft, if a registered medical product follows post-market surveillance and encounters unforeseen defects, no penalties will be issued. Also, minor infractions that are quickly fixed without causing harm may result in no penalties for first-time offenders. On the other hand, severe penalties will be implemented if the device, drug, or cosmetic is fake, does not match appropriate required technical standards, or cause significant injuries.
These updated draft penalties for medical companies closely follow the initial regulation – the 2012 Rules for Applicable Discretion of Administrative Penalties for Drugs and Medical Devices. However, the above-mentioned updates are important for companies to follow and fully comprehend. It is expected that this draft registration will be finalized soon.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------