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CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices

3. September 2015

The China Food and Drug Administration (CFDA, chin: 国家食品药品监督管理总局) recently formulated and issued three appendixes for good manufacturing practice for medical devices. The purpose is to strengthen the supervision and management of medical devices, improve enterprises’ quality management level, and to ensure the safety and effectiveness of medical devices.

The three appendixes on Promulgation of Good Manufacturing Practice for Medical Devices are the following:

  1. Appendix for Sterile Medical Devices (No. 101 Announcement of 2015)
  2. Appendix for Implantable Medical Devices (No. 102 Announcement of 2015)
  3. Appendix for In Vitro Diagnosis Reagents (No. 103 Announcement of 2015)

These appendixes were created in accordance with the “Regulations for the Supervision and Administration of Medical Devices” (chin: 医疗器械 监督管理条例(修订草案) (State Council Decree No. 650) and the Administrative Measures for the Supervision of Medical Device Manufacturing (CFDA Order No. 7).

In the three appendixes, there is particular emphasis on the Good Manufacturing Practice of sterile medical devices, implantable medical devices and in vitro diagnosis reagents, which will come into effect as of October 1, 2015.
Chinese Female Woman Scientist & Microscope In LaboratoryIt is expected that there will be more announcements, reforms and changes to the CFDA regulations in the near future. In our News section on our website, we will keep you informed regarding the official announcements.

If you want to learn more about CFDA certification for medical devices and products, please visit the CFDA section on our website. We also provide more detailed knowledge regarding CFDA in our free brochure “CFDA China – The Booklet” that can be downloaded here.

Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673) or email and we will be happy to answer questions.


MPR Author

About the author: Julian Busch is founder and Managing Director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150