New Medical Device Registration and Filing Rules to Take Effect in China

by Grace Wang Sep 18, 2021

On Aug. 26, China State Administration for Market Regulation released Administrative Measures for Medical Device Registration and Filing1 (hereafter referred to as Measures), set to take effect on Oct. 1, 2021.

The Measures was formulated pursuant to the Regulations for the Supervision and Administration of Medical Devices2, which came into force on June 1, 2021.

The content of this article is as follows:

  1. Application scope of the Measures;

  2. Medical device classification in China;

  3. Introduction to medical device registration;

  4. Introduction to medical device filing;

  5. Qualification of registration/filing applicant/agent;

  6. Competent authority to submit application/file documentation to;

  7. Detailed introduction to registration application/filing documentation;

  8. Conditions for clinical evaluation exemption;

  9. Special approval for medical devices;

  10. Product change and validity extension;

  11. Adjustment to the class of a registered medical device.

Grace Wang
ChemLinked Regulatory Analyst
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