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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.covingtonblogs.com/2023/11/22/china-issues-draft-rules-governing-the-discretion-of-administrative-penalties-for-drugs-devices-and-cosmetics/