Some devices are no longer managed as class I medical devices in China

Medical device manufacturer are not required to register for class I medical devices under the new medical device regulations (known as decree No. 650 ), and only required to record in CFDA, and the record keeping effects permanent once it approved by CFDA. It significantly simplifies the administrative approval process and reduces the cost and duration for applicant.

CFDA have modified the classification of class I medical devices and issued the "Catalogue of class I medical devices" on May 30^th 2014. Any devices not listed in this catalogue will be considered as non class I medical devices. There are some devices deemed to be no longer managed as class I medical devices in China:

• Sterile medical device
• Sanitary materials contained disinfectant
• Surgical instruments used with the endoscope
• Orthopedic surgical instruments directly contacted with intervertebral space when used
• Collective packing product contained higher control level medical devices

Foreign devices manufacturer need to understand that you are required to update your registration if the classification of your product changed. If you would like to confirm the new classification of your medical device and how to comply with it, please join CIRS regulatory assistant program (MDRAP).