New Provisions for the Sale of Medical Devices in China

September 09, 2022 | BY

Susan Mok

Jianwei (Jerry) Fang, Chao (David) Lv and Runyang Liu of Zhong Lun Law Firm highlight the newly revised regulatory measures for medical devices business enterprises and discuss heightened compliance requirements.

 

Summary

  • The New Measures enable applicants for the registration or record-filing to entrust the sale of the medical device to medical device business enterprises.
  • To simplify application procedures, the administrative approval process and requirements for application have been comprehensively optimized.
  • Business enterprises of medical devices are required to establish quality management systems and control measures covering the whole circulation process.
  • The overall supervision has been strengthened by means of enhancing external supervision measures and increasing the penalty for illegal acts.
  • Foreign enterprises are advised to formulate comprehensive compliance systems to fully comply with tightened regulations.

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